A randomized, controlled trial comparing local infiltration analgesia with epidural infusion for total knee arthroplasty

Background

There have been few studies describing wound infiltration with additional intraarticular administration of multimodal analgesia for total knee arthroplasty (TKA). In this study, we assessed the efficacy of wound infiltration combined with intraarticular regional analgesia with epidural infusion on analgesic requirements and postoperative pain after TKA.

Methods

40 consecutive patients undergoing elective, primary TKA were randomized into 2 groups to receive either (1) intraoperative wound infiltration with 150 mL ropivacaine (2 mg/mL), 1 mL ketorolac (30 mg/mL), and 0.5 mL epinephrine (1 mg/mL) (total volume 152 mL) combined with intraarticular infusion (4 mL/h) of 190 mL ropivacaine (2 mg/mL) plus 2 mL ketorolac (30 mg/mL) (group A), or (2) epidural infusion (4 mL/h) of 192 mL ropivacaine (2 mg/mL) combined with 6 intravenous administrations of 0.5 mL ketorolac (30 mg/mL) for 48 h postoperatively (group E). For rescue analgesia, intravenous patient-controlled-analgesia (PCA) morphine was used.Morphine consumption, intensity of knee pain (0–100 mm visual analog scale), and side effects were recorded. Length of stay and corrected length of stay were also recorded (the day-patients fulfilled discharge criteria).

Results

The median cumulated morphine consumption, pain scores at rest, and pain scores during mobilization were reduced in group A compared to group E. Corrected length of stay was reduced by 25% in group A compared to group E.

Interpretation

Peri- and intraarticular analgesia with multimodal drugs provided superior pain relief and reduced morphine consumption compared with continuous epidural infusion with ropivacaine combined with intravenous ketorolac after TKA.Total knee arthroplasty (TKA) usually results in severe postoperative pain. Continuous epidural infusion with a local anesthetic is a standard regime for postoperative analgesia after TKA. Epidural analgesia and also peripheral nerve block analgesia have been shown to reduce opioid consumption compared with intravenous patient-controlled analgesia (PCA). Even though both modalities reduce the occurrence of the well-known side effects of opioid drugs, they involve extra equipment and are associated with substantial side effects (Choi et al. 2003, Davies et al. 2004, Boezaart 2006). Wound infiltration with multimodal analgesia has been a controversial issue for many years (Dahl et al. 1994). Different modes of perioperative analgesia either without or combined with intraarticular infusion or bolus injection(s) for both TKA and total hip arthroplasty have been described (Bianconi et al. 2003, Rasmussen et al. 2004, Reilly et al. 2005, Andersen et al. 2007a, b). Only a few studies have described high-volume peri- and intraarticular analgesia for TKA (Busch et al. 2006, Vendittoli et al. 2006, Toftdahl et al. 2007). The hypothesis in our trial was that wound infiltration and intraarticular infusion of ropivacaine and ketorolac would reduce opioid consumption during the active treatment period (0–48 h postoperatively) after TKA compared to epidural infusion of ropivacaine and intravenous ketorolac. Primary outcome was 48-h opioid use. Secondary outcomes included pain at rest and during mobilization, side effects, length of hospital stay (LOS), and corrected length of stay (the day-patients fulfilled discharge criteria).     

Pain control after total knee arthroplasty: a randomized trial comparing local infiltration anesthesia and continuous femoral block

Background and purpose

Pain after total knee arthroplasty (TKA) is usually severe, and epidural analgesia or femoral nerve block has been considered to be an effective pain treatment. Recently, local infiltration analgesia (LIA) has become increasingly popular but the outcome of this method regarding the analgesic effect has not been fully evaluated. We compared local infiltration analgesia and femoral block with regard to analgesia and morphine demand during the first 24 h after TKA.

Methods

40 patients undergoing TKA under spinal anesthesia were randomized to receive femoral nerve block (group F) or peri- and intraarticular infiltration analgesia (group LIA) with a mixture containing ropivacaine, ketorolac, and epinephrine. All patients had access to intravenous patient-controlled analgesia (PCA) with morphine postoperatively. Pain intensity at rest and upon movement was assessed on a numeric rating scale (0–10) on an hourly basis over 24 h if the patients were awake.

Results

The average pain at rest was marginally lower with LIA (1.6) than with femoral block (2.2). Total morphine consumption per kg was similar between the 2 groups. Ancillary analysis revealed that 1 of 20 patients in the LIA group reported a pain intensity of > 7 upon movement, as compared to 7 out of 19 in the femoral block group (p = 0.04).

Interpretation

Both LIA and femoral block provide good analgesia after TKA. LIA may be considered to be superior to femoral block since it is cheaper and easier to perform.Pain after total knee arthroplasty (TKA) is usually severe and difficult to manage, and insufficient pain relief may delay recovery. The most effective pain treatment has traditionally been epidural analgesia or femoral nerve block (Singelyn et al. 1998, Ganapathy et al. 1999, Chelly et al. 2001, Davies et al. 2004, Ilfeld et al. 2006) in combination with opioid analgesics and non-steroidal anti-inflammatory drugs (NSAIDs, cyclooxygenase (cox) inhibitors). Each of these methods has its specific side effects. Urinary retention and muscular weakness are often reported after epidural analgesia. Unpleasant numbness of a large part of the lower extremity is common after femoral block. Opioid analgesics often cause sedation, nausea and vomiting, and also urinary retention. Non-selective cox inhibitors may cause gastrointestinal bleeding, renal complications, and epidural hematoma, especially in combination with anti-thrombotic prophylaxis with low-molecular-weight heparin (Afzal et al. 2006).An alternative method for postoperative pain relief after TKA, which has attracted growing interest in recent years, is multimodal wound infiltration analgesic technique consisting of peri- and intraarticular infiltration of local anesthetics and NSAID in the knee (LIA) (Andersen et al. 2008a, b, Kerr and Kohan 2008). This technique appears to offer several advantages over traditional methods, since the analgesia affects only the surgical area with limited interference of the muscle strength. Thus, easier rehabilitation of the operated extremity and earlier discharge from the hospital can be expected (Reilly et al. 2005, Essving et al. 2009). Furthermore, recent studies have shown that the LIA technique reduces the requirement for postoperative analgesia with opioids (Tanaka et al. 2001, Busch et al. 2006, Vendittoli et al. 2006).Only a few investigators have randomly compared LIA with other methods with proven analgesic effect, such as femoral block or epidural analgesia (Parvataneni et al. 2007, Toftdahl et al 2007). Parvatanemi and collaborators (2007) have shown that a combination of a femoral block and local administration of bupivacaine, morphine, and epinephrine results in better pain relief and patient satisfaction than femoral block. Toftdahl and collaborators (2007) presented data suggesting that LIA with ropivacaine, ketorolac, and epinephrine results in faster postoperative activation, as indicated by being better able to walk more than 3 m on the first postoperative day as compared to femoral block. A retrospective comparison (DeWeese et al. 2001) indicated that epidural anesthesia with fentanyl and bupivacaine resulted in better pain relief and less use of other analgesics than did continuous infiltration of the knee with bupivacaine.Femoral block is known to be an effective pain treatment after TKA (Szczukowski et al. 2004, Navas et al. 2005, Duarte et al. 2006). We compared the LIA technique with femoral block regarding efficacy of pain management at rest and upon movement after TKA. We also investigated whether LIA reduced the demand for intravenous morphine, administered via a patient-controlled analgesia (PCA) pump during the first 24 h postoperatively.     

High-volume infiltration analgesia in bilateral hip arthroplasty. A randomized, double-blind placebo-controlled trial

Background and purpose

High-volume infiltration analgesia may be effective in postoperative pain management after hip arthroplasty but methodological problems prevent exact interpretation of previous studies.

Methods

In a randomized, double-blind placebo-controlled trial in 12 patients undergoing bilateral total hip arthroplasty (THA) in a fast-track setting, saline or high-volume (170 mL) ropivacaine (0.2%) with epinephrine (1:100,000) was administered to the wound intraoperatively along with supplementary postoperative injections via an intraarticular epidural catheter. Oral analgesia was instituted preoperatively with a multimodal regimen (gabapentin, celecoxib, and acetaminophen). Pain was assessed repeatedly for 48 hours postoperatively, at rest and with 45° hip flexion.

Results

Pain scores were low and similar between ropivacaine and saline administration. Median hospital stay was 4 (range 2–7) days.

Interpretation

Intraoperative high-volume infiltration with 0.2% ropivacaine with repeated intraarticular injections postoperatively may not give a clinically relevant analgesic effect in THA when combined with a multimodal oral analgesic regimen with gabapentin, celecoxib, and acetaminophen.Continuous epidural analgesia (Choi et al. 2003) or continuous or single-shot peripheral nerve blocks (Boezaart 2006, Ilfeld et al. 2008) may provide sufficient analgesia after total hip arthroplasty (THA), but both techniques are associated with potential motor blockade, thereby hindering early rehabilitation (Choi et al 2003, Boezaart 2006, Ilfeld et al. 2008).Local infiltration analgesia (LIA) (Röstlund and Kehlet 2007, Kerr and Kohan 2008, Otte et al. 2008) with intraoperative infiltration of local anesthetic in the surgical wound and subsequent supplementary postoperative intraarticular or wound injections has been reported to be effective in knee arthroplasty (Andersen et al. 2008). However, for THA only limited and inconclusive data are available from placebo-controlled and randomized trials (Bianconi et al. 2003, Andersen et al. 2007 a, b, Busch et al. 2010) and from non-randomized cohort studies (Kerr and Kohan 2008, Otte et al. 2008). We therefore decided to evaluate the analgesic efficacy of LIA in a placebo-controlled, randomized and double-blind trial in fast-track bilateral hip arthroplasty with administration of either ropivacaine or saline to the wound, thereby limiting the large inter-individual pain response to THA. This design has proven valid in assessing the analgesic value of LIA in TKA (Andersen et al. 2008). The primary endpoint was pain on flexion of the hip joint 8 hours postoperatively.     

Why still in hospital after fast-track hip and knee arthroplasty?

Background and purpose

Length of stay (LOS) following total hip and knee arthroplasty (THA and TKA) has been reduced to about 3 days in fast-track setups with functional discharge criteria. Earlier studies have identified patient characteristics predicting LOS, but little is known about specific reasons for being hospitalized following fast-track THA and TKA.

Patients and methods

To determine clinical and logistical factors that keep patients in hospital for the first postoperative 24–72 hours, we performed a cohort study of consecutive, unselected patients undergoing unilateral primary THA (n = 98) or TKA (n = 109). Median length of stay was 2 days. Patients were operated with spinal anesthesia and received multimodal analgesia with paracetamol, a COX-2 inhibitor, and gabapentin—with opioid only on request. Fulfillment of functional discharge criteria was assessed twice daily and specified reasons for not allowing discharge were registered.

Results

Pain, dizziness, and general weakness were the main clinical reasons for being hospitalized at 24 and 48 hours postoperatively while nausea, vomiting, confusion, and sedation delayed discharge to a minimal extent. Waiting for blood transfusion (when needed), for start of physiotherapy, and for postoperative radiographic examination delayed discharge in one fifth of the patients.

Interpretation

Future efforts to enhance recovery and reduce length of stay after THA and TKA should focus on analgesia, prevention of orthostatism, and rapid recovery of muscle function.Total hip and total knee arthroplasty (THA and TKA) are frequent operations with an average length of stay (LOS) of about 6–12 days in the United Kingdom, Germany, and Denmark (Husted et al. 2006, Bundesauswertung 2009, NHS 2010).During the last decade, however, there has been increased interest in optimal multimodal perioperative care to enhance recovery (the fast-track methodology). Improvement of analgesia; reduction of surgical stress responses and organ dysfunctions including nausea, vomiting, and ileus; early mobilization; and oral nutrition have been of particular interest (Kehlet 2008, Kehlet and Wilmore 2008). These principles have also been applied to THA and TKA, resulting in improvements in pain treatment with multimodal opioid-sparing regimens including a local anesthetic infiltration technique (LIA) or peripheral nerve blocks to facilitate early mobilization (Ilfeld et al. 2006a, b, 2010a, Andersen et al. 2008, Kerr and Kohan 2008), and allowing functional rehabilitation to be initiated a few hours postoperatively (Holm et al. 2010)—ultimately leading to a reduction in LOS (Husted et al. 2008, Barbieri et al. 2009, Husted et al. 2010a, b). Using these evidence-based regimens combined with an improved logistical setup, LOS is reduced to about 2–4 days (Kerr and Kohan 2008, Husted et al. 2010 a,b,c, Lunn et al. 2011).Having well-defined functional discharge criteria is imperative in order to ensure a safe discharge—and it is mandatory if meaningful comparison of LOS is done following alterations in the track (Husted et al. 2008). In the same fast-track setting, an earlier study focused on patient characteristics predicting LOS (Husted et al. 2008). However, little is known about the specific reasons for why patients are hospitalized during the first 1–3 days after THA or TKA; i.e. why can patients not be discharged?We therefore analyzed clinical and organizational factors responsible for being hospitalized in a well-defined prospective setup in a fast-track unit. This unit had previously documented LOS of about 2–3 days (Andersen et al. 2008, Holm et al. 2010, Husted et al. 2010b, c, Lunn et al. 2011).     

Locking plate osteosynthesis in displaced 4-part fractures of the proximal humerus

Background and purpose

There is considerable uncertainty about the optimal treatment of displaced 4-part fractures of the proximal humerus. Within the last decade, locking plate technology has been considered a breakthrough in the treatment of these complex injuries.

Methods

We systematically identified and reviewed clinical studies on the benefits and harms after osteosynthesis with locking plates in displaced 4-part fractures.

Results

We included 14 studies with 374 four-part fractures. There were 10 case series, 3 retrospective observational comparative studies, 1 prospective observational comparative study, and no randomized trials. Small studies with a high risk of bias precluded reliable estimates of functional outcome. High rates of complications (16–64%) and reoperations (11–27%) were reported.

Interpretation

The empirical foundation for the value of locking plates in displaced 4-part fractures of the proximal humerus is weak. We emphasize the need for well-conducted randomized trials and observational studies.There is considerable uncertainty about the optimal treatment of displaced 4-part fractures of the proximal humerus (Misra et al. 2001, Handoll et al. 2003, Bhandari et al. 2004, Lanting et al. 2008). Only 2 small inconclusive randomized trials have been published (Stableforth 1984, Hoellen et al. 1997). A large number of interventions are used routinely, ranging from a non-operative approach to open reduction and internal fixation (ORIF), and primary hemiarthroplasty (HA).In the last decade, locking plate technology has been developed and has been heralded as a breakthrough in the treatment of fractures in osteoporotic bone (Gautier and Sommer 2003, Sommer et al. 2003, Haidukewych 2004, Miranda 2007). Locking plate technique is based on the elimination of friction between the plate and cortex, and relies on stability between the subchondral bone and screws. Multiple multidirectional convergent and divergent locking screws enhance the angular stability of the osteosynthesis, possibly resulting in better postoperative function with reduced pain. Reported complications include screw cut-out, varus fracture collapse, tuberosity re-displacement, humeral head necrosis, plate impingement, and plate or screw breakage (Hall et al. 2006, Tolat et al. 2006, van Rooyen et al. 2006, Agudelo et al. 2007, Gardner et al. 2007, Khunda et al. 2007, Ring 2007, Smith et al. 2007, Voigt et al. 2007, Egol et al. 2008, Kirchhoff et al. 2008, Owsley and Gorczyca 2008, Brunner et al. 2009, Micic et al. 2009, Sudkamp et al. 2009). The balance between the benefit and harms of the intervention seems delicate.Several authors of narrative reviews and clinical series have strongly recommended fixation of displaced 4-part fractures of the humerus with locking plates (Bjorkenheim et al. 2004, Hente et al. 2004, Hessler et al. 2006, Koukakis et al. 2006, Kilic et al. 2008, Korkmaz et al. 2008, Shahid et al. 2008, Papadopoulos et al. 2009, Ricchetti et al. 2009) and producers of implants unsurprisingly strongly advocate them (aap Implantate 2010, Stryker 2010, Synthes 2010, Zimmer 2010). Despite the increasing use of locking plates (Illert et al. 2008, Ricchetti et al. 2009), we have been unable to identify systematic reviews on the benefits and harms of this new technology in displaced 4-part fractures. Thus, we systematically identified and reviewed clinical studies on the benefits and harms after osteosynthesis with locking plates in displaced 4-part fractures of the proximal humerus.     

Perioperative mortality after hemiarthroplasty related to fixation method

Background and purpose

The appropriate fixation method for hemiarthroplasty of the hip as it relates to implant survivorship and patient mortality is a matter of ongoing debate. We examined the influence of fixation method on revision rate and mortality.

Methods

We analyzed approximately 25,000 hemiarthroplasty cases from the AOA National Joint Replacement Registry. Deaths at 1 day, 1 week, 1 month, and 1 year were compared for all patients and among subgroups based on implant type.

Results

Patients treated with cemented monoblock hemiarthroplasty had a 1.7-times higher day-1 mortality compared to uncemented monoblock components (p < 0.001). This finding was reversed by 1 week, 1 month, and 1 year after surgery (p < 0.001). Modular hemiarthroplasties did not reveal a difference in mortality between fixation methods at any time point.

Interpretation

This study shows lower (or similar) overall mortality with cemented hemiarthroplasty of the hip.The frequency of hip fractures is increasing with our ageing population, with an annual incidence of between 1.4 and 5 per 103 per year (Lonnroos et al. 2006, Icks et al. 2008, Varez-Nebreda et al. 2008). Health model projections have estimated that 6.3 million hip fractures will occur annually worldwide within the next 40 years (Cooper et al. 1992), imposing a significant economic health burden. There is a large reported perioperative mortality rate in this population, ranging from 2.4% to 8.2% at 1 month (Parvizi et al. 2001, Radcliff et al. 2008) and over 25% at 1 year (Elliott et al. 2003, Jiang et al. 2005). Furthermore, it was recently reported that the current mortality rate is higher now than 25 years ago (Vestergaard et al. 2007a). Today, it is generally accepted that displaced intracapsular fractures are best treated with arthroplasty rather than internal fixation (Keating et al. 2006, Leighton et al. 2007). In the at-risk population, however, multiple comorbidities are common and the best form of component fixation is in question.Bone cement implantation syndrome is a well-described complication of cemented hip arthroplasty. It is characterized by a systemic drop in systolic blood pressure, hypoxemia, pulmonary hypertension, cardiac dysrhythmias, and occasionally cardiac arrest and death (Rinecker 1980, Orsini et al. 1987, Parvizi et al. 1999). The prevailing theory to explain the pathophysiology of this phenomenon is embolism of fat, marrow contents, bone, and to some degree methylmethacrylate to the lung (Rinecker 1980, Elmaraghy et al. 1998, Parvizi et al. 1999, Koessler et al. 2001). An increased degree of pulmonary insult with fat microemboli has been demonstrated (mostly in randomized controlled trials) during insertion of a cemented femoral stem rather than an uncemented implant (Orsini et al. 1987, Ries et al. 1993, Christie et al. 1994, Pitto et al. 1999), presumably due to increased intramedullary femoral canal pressures in the cemented group (Kallos et al. 1974, Orsini et al. 1987). These pressures can be reduced by the use of distal venting holes in the femur during stem insertion (Engesæter et al. 1984). It has been shown previously by single-institutional review that patients undergoing cemented hip arthroplasty have a higher intraoperative mortality rate relative to uncemented arthroplasty, presumably due to a reduced incidence of fat embolism in the latter group (Parvizi et al. 1999). The increased mortality risk was also present at 30 days in the treatment of acute fractures with cemented arthroplasty, also from a single-institutional review (Parvizi et al. 2004). Although cement-related mortality is rare (Dearborn and Harris 1998, Parvizi et al. 1999, 2001, 2004, Weinrauch et al. 2006), it is a devastating complication—often reported through observational studies or literature reviews. Proponents of uncemented hip arthroplasty often cite this concern to support their reluctance to use cemented hip arthroplasty in both elective procedures and fracture management. However, many different types of studies have been unable to identify any increased mortality risk with the use of cement (Lausten and Vedel 1982 (observational), Emery et al. 1991 (RCT), Lo et al. 1994 (observational), Khan et al. 2002a,b (literature review), Parker and Gurusamy 2004 (literature review)) and others have shown a decrease in mortality at 30 days when cement is used (Foster et al. 2005).Cemented hip hemiarthroplasty appears to offer improved rate of return to baseline function, reduced postoperative pain, and superior long-term survivorship relative to uncemented arthroplasty (Khan et al. 2002a, b, Parker and Gurusamy 2004). We reasoned that failure to return to baseline function after hemiarthroplasty may be another risk factor for perioperative mortality (Hannan et al. 2001, Braithwaite et al. 2003). Lower revision rates for cemented prostheses and increased mortality at revision surgery contribute further to reducing the overall mortality risk. We evaluated the relationship between the method of fixation of hip arthroplasty and perioperative mortality using a large national joint replacement registry.     

Role of preoperative pain,muscle function,and activity level in discharge readiness after fast-track hip and knee arthroplasty

Methods Before surgery, hip pain (THA) or knee pain (TKA), lower-extremity muscle power, functional performance, and physical activity were assessed in a sample of 150 patients and used as independent variables to predict the outcome (dependent variable)—readiness for hospital discharge —for each type of surgery. Discharge readiness was assessed twice daily by blinded assessors.Results Median discharge readiness and actual length of stay until discharge were both 2 days. Univariate linear regression followed by multiple linear regression revealed that age was the only independent predictor of discharge readiness in THA and TKA, but the standardized coefficients were small (≤ 0.03).Interpretation These results support the idea that fast-track THA and TKA with a length of stay of about 2–4 days can be achieved for most patients independently of preoperative functional characteristics.Over the last decade, length of stay (LOS) with discharge to home after primary THA and TKA has declined from about 5–10 days to about 2–4 days in selected series and larger nationwide series (Malviya et al. 2011, Raphael et al. 2011, Husted et al. 2012, Kehlet 2013, Hartog et al. 2013, Jørgensen and Kehlet 2013). However, there is a continuing debate about whether selected patients only or all patients should be scheduled for “fast-track” THA and TKA in relation to psychosocial factors and preoperative pain and functional status (Schneider et al. 2009, Hollowell et al. 2010, Macdonald et al. 2010, Antrobus and Bryson 2011, Jørgensen and Kehlet 2013), or whether organizational or pathophysiological factors in relation to the surgical trauma may determine the length of stay (Husted et al. 2011, Husted 2012).We studied the role of THA and TKA patients’ preoperative pain and functional characteristics in discharge from 2 orthopedic departments with well-established fast-track recovery regimens (Husted et al. 2010).     

Prognostic factors in lumbar spinal stenosis surgery: A prospective study of imaging- and patient-related factors in 109 patients who were operated on by decompression

Background and purpose

A considerable number of patients who undergo surgery for spinal stenosis have residual symptoms and inferior function and health-related quality of life after surgery. There have been few studies on factors that may predict outcome. We tried to find predictors of outcome in surgery for spinal stenosis using patient- and imaging-related factors.

Patients and methods

109 patients in the Swedish Spine Register with central spinal stenosis that were operated on by decompression without fusion were prospectively followed up 1 year after surgery. Clinical outcome scores included the EQ-5D, the Oswestry disability index, self-estimated walking distance, and leg and back pain levels (VAS). Central dural sac area, number of levels with stenosis, and spondylolisthesis were included in the MRI analysis. Multivariable analyses were performed to search for correlation between patient-related and imaging factors and clinical outcome at 1-year follow-up.

Results

Several factors predicted outcome statistically significantly. Duration of leg pain exceeding 2 years predicted inferior outcome in terms of leg and back pain, function, and HRLQoL. Regular and intermittent preoperative users of analgesics had higher levels of back pain at follow-up than those not using analgesics. Low preoperative function predicted low function and dissatisfaction at follow-up. Low preoperative EQ-5D scores predicted a high degree of leg and back pain. Narrow dural sac area predicted more gains in terms of back pain at follow-up and lower absolute leg pain.

Interpretation

Multiple factors predict outcome in spinal stenosis surgery, most importantly duration of symptoms and preoperative function. Some of these are modifiable and can be targeted. Our findings can be used in the preoperative patient information and aid the surgeon and the patient in a shared decision making process.Decompressive surgery for lumbar spinal stenosis is the most frequently performed spine operation in many countries (Weinstein et al. 2006, Strömqvist et al. 2009). However, one third of patients are not satisfied with the outcome because of residual leg and back pain, inferior function, and poor health-related quality of life (Katz et al. 1995, Airaksinen et al. 1997, Jönsson et al. 1997, Jansson et al. 2009, Strömqvist et al. 2009, Hara et al. 2010).2 recent randomized studies have shown surgery to be superior to nonoperative treatment in lumbar spinal stenosis (Malmivaara et al. 2007, Weinstein et al. 2008), but many patients improve without surgical treatment (Malmivaara et al. 2007). The question remains as to who benefits most from surgery. Identification of prognostic factors that can aid in selection of patients for surgery is therefore important. Prognostic factors in lumbar spinal stenosis surgery have been studied, but they are not well defined (Turner et al. 1992, Aalto et al. 2006). Aalto et al. (2006) reviewed studies of lumbar spinal stenosis surgery and found that only 21 studies of 885 were of sufficient quality to merit identification of prognostic factors. The main reason for exclusion was a retrospective study design and a limited number of predictors. Cardiovascular and overall comorbidity, disorders influencing walking ability, self-rated health, income, severity of central stenosis, and severity of scoliosis were found to be predictors of outcome, but no single study could identify more than one of these predictors. More recently, smoking, depression, psychiatric illness, and high body mass index have been found to be predictive of negative outcome, as have long duration of symptoms and preoperative resting numbness (Ng et al. 2007, Hara et al. 2010, Athiviraham et al. 2011, Radcliff et al. 2011, Sandén et al. 2011, Sinikallio et al. 2011).Cross-sectional imaging (most often MRI) has an important role in confirming the diagnosis of spinal stenosis, and is essential for surgical planning. Even so, the prognostic value of the narrowness of the dural sac area is not well established (Jönsson et al 1997, Amundsen et al. 2000, Yukawa et al. 2002). Studies incorporating both imaging and patient-related factors in a systematic way have been exceedingly rare (Amundsen et al. 2000, Yukawa et al. 2002).We used patient data from the Swedish Spine Register protocol (Strömqvist et al. 2009) and MRI measurements of central dural sac area, multilevel stenosis, and spondylolisthesis to find predictors of outcome in terms of function, HRLQoL, and leg and back pain after decompression for lumbar spinal stenosis.     

Effects of metal-on-metal wear on the host immune system and infection in hip arthroplasty

Background and purpose

Joint replacement with metal-on-metal (MOM) bearings have gained popularity in the last decades in young and active patients. However, the possible effects of MOM wear debris and its corrosion products are still the subject of debate. Alongside the potential disadvantages such as toxicity, the influences of metal particles and metal ions on infection risk are unclear.

Methods

We reviewed the available literature on the influence of degradation products of MOM bearings in total hip arthroplasties on infection risk.

Results

Wear products were found to influence the risk of infection by hampering the immune system, by inhibiting or accelerating bacterial growth, and by a possible antibiotic resistance and heavy metal co-selection mechanism.

Interpretation

Whether or not the combined effects of MOM wear products make MOM bearings less or more prone to infection requires investigation in the near future.Many young patients with painful coxarthrosis want to return to a high level of activity and require an implant that provides durability. The low wear rates of metal-on-metal (MOM) bearings have led to a resurgence in the use of MOM bearings (Wagner and Wagner 2000, Silva et al. 2005, Pollard et al. 2006, Vendittoli et al. 2007, Delaunay et al. 2008). 35% of all prostheses in the United States in 2006 (Bozic et al. 2009) and 16% of all prostheses implanted in Australia from 1999 through 2007 had MOM bearings (Graves et al. 2008).Metal alloys used in MOM bearings degrade through wear, from corrosion, or by a combination of the two (Yan et al. 2006, Jacobs et al. 2008). Consequently, MOM bearings produce nanometer- to submicrometer-sized metal particles (Campbell et al. 1996, Doorn et al. 1998). The high number of these very small particles presents a large cumulative surface area for corrosion. The biological effects of these particles and their corrosion products in the human body are for the most part unclear. Since the renewed interest in MOM bearings, extensive research has been done to determine the consequences of local and systemic exposure to wear particles and accompanying biologically active corrosion products (Amstutz and Grigoris 1996). It is well known that metal debris can induce pathological changes such as the release of inflammatory cytokines from macrophages, histiocytosis, fibrosis, and necrosis (Basle et al. 1996, Granchi et al. 1998, Caicedo et al. 2008, 2009). Metal debris is also thought to be associated with hypersensitivity and osteolysis (Hallab et al. 2000, 2010, Goodman 2007b, Carr and DeSteiger 2008, Huber et al. 2009). However, there is very little literature on the bacteriological effects of these degradation products (Anwar et al. 2007, Hosman et al. 2009). It is therefore unclear whether they can influence the risk of infection.The Australian and New Zealand joint registries have shown that between 9% and 15% of all total hip arthroplasty (THA) revisions are carried out because of infections related to the primary prosthesis (Rothwell et al. 2007, Graves et al. 2008). In cases of infection, bacteria adopt a biofilm mode of growth on the surface of the prosthesis, thus increasing the antibiotic resistance and resulting in major difficulties in treatment (Trampuz and Widmer 2006). Removal and replacement of an infected implant is usually required to eliminate the infection (Bozic and Ries 2005, Vincent et al. 2006). Recent research has suggested that particulate debris of any composition promotes bacterial growth by providing a scaffold for bacterial adhesion and biofilm growth (Anwar et al. 2007). On the other hand, high concentrations of metal ions have been shown to have bacteriostatic properties (Hosman et al. 2009).Considering the paucity of publications on the effects of MOM particles on infection, we performed a review of the literature on the influence of MOM wear particles and their corrosion products on the risk of infection.     

No clinical benefit of gender-specific total knee arthroplasty: A systematic review and meta-analysis of 6 randomized controlled trials

Background and purpose

There is no consensus regarding the clinical relevance of gender-specific prostheses in total knee arthroplasty (TKA). We summarize the current best evidence in a comparison of clinical and radiographic outcomes between gender-specific prostheses and standard unisex prostheses in female patients.

Methods

We used the PubMed, Embase, Cochrane, Science Citation Index, and Scopus databases. We included randomized controlled trials published up to January 2013 that compared gender-specific prostheses with standard unisex prostheses in female patients who underwent primary TKAs.

Results

6 trials involving 423 patients with 846 knee joints met the inclusion criteria. No statistically significant differences were observed between the 2 designs regarding pain, range of motion (ROM), knee scores, satisfaction, preference, complications, and radiographic results. The gender-specific design (Gender Solutions; Zimmer Inc, Warsaw, Indiana) reduced the prevalence of overhang. However, it had less overall coverage of the femoral condyles compared to the unisex group. In fact, the femoral prosthesis in the standard unisex group matched better than that in the gender-specific group.

Interpretation

Gender-specific prostheses do not appear to confer any benefit in terms of clinician- and patient-reported outcomes for the female knee.Women account for almost two-thirds of knee arthroplasties (Kurtz et al. 2007). Recently, a possible effect of gender on functional outcomes and implant survivorship has been identified (Vincent et al. 2006, Ritter et al. 2008, Kamath et al. 2010, Parsley et al. 2010, O’Connor 2011). Gender differences in the anatomy of the distal femur are well documented (Conley et al. 2007, Yue et al. 2011a, b, Yan et al. 2012, Zeng et al. 2012). Women tend to have a less prominent anterior condyle (Conley et al. 2007, Fehring et al. 2009), a higher quadriceps angle (Q-angle) (Hsu et al. 1990, Woodland et al. 1992), and a reduced mediolateral to anteroposterior aspect ratio (Chin et al. 2002, Chaichankul et al. 2011). Investigators have found that standard unisex knee prostheses may not equally match the native anatomy in male and female knees (Clarke and Hentz 2008, Yan et al. 2012). A positive association between the femoral component size and the amount of overhang was observed in females, and femoral component overhang (≥ 3 mm) may result in postoperative knee pain or reduced ROM (Hitt et al. 2003, Lo et al. 2003, Mahoney et al. 2010).The concept of gender-specific knee prostheses was introduced to match these 3 anatomic differences in the female population (Conley et al. 2007). It includes a narrower mediolateral diameter for a given anteroposterior dimension, to match the female knee more closely. Additionally, the anterior flange of the prothesis was modified to include a recessed patellar sulcus and reduced anterior condylar height (to ovoid “overstuffing” during knee flexion) and a lateralized patellar sulcus (to accommodate the increased Q-angle associated with a wider pelvis).Several randomized controlled trials (RCTs) have failed to establish the superiority of the gender-specific prosthesis over the unisex knee prosthesis in the female knee (Kim et al. 2010a, b, Song et al. 2012a, Thomsen et al. 2012, von Roth et al. 2013). In contrast, other studies have found higher patient satisfaction and better radiographic fit in the gender-specific TKAs than in the standard unisex TKAs (Clarke and Hentz 2008, Parratte et al. 2011, Yue et al. 2014). We therefore performed a systematic review and meta-analysis to compare the clinical and radiographic results of TKA in female patients receiving gender-specific prostheses or standard unisex prostheses.     

Persistent pain is common 1–2 years after shoulder replacement: A nationwide registry-based questionnaire study of 538 patients

Results 538 patients were available for analysis. The prevalence of persistent pain was 22% (CI: 18–25), and the prevalence of presumed neuropathic pain was 13% (CI: 10–16). Persistent pain was more frequent in fracture patients (29%) than in osteoarthritis patients (16%), while the prevalence of neuropathic pain was similar. Severe pain during the first postoperative week increased the risk of persistent pain. Risk also increased with hemiprosthesis (as compared to total prosthesis) in osteoarthritis patients, and with previous osteosynthesis and pain elsewhere in fracture patients.Interpretation Persistent pain after shoulder replacement is a daily burden for many patients. Further studies should address patient and prosthesis selection, postoperative pain management, and follow-up of these patients.There is a substantial amount of literature documenting that there is a possible risk of persistent pain after almost any surgical procedure (Macrae 2001, Johansen et al. 2012). The prevalence rates are highly dependent on the type of surgery, and vary from 5% to 85% (Kehlet et al. 2006, Macrae 2008). The consequences of chronic or persistent postsurgical pain are significant, not only in terms of suffering and reduced quality of life for the individual patient, but also with regard to the subsequent costs to healthcare services and social services. Many authors have reported putative risk factors for persistent pain, including genetic factors, age, psychosocial factors, type of anesthesia, pain elsewhere than the surgical site, other comorbidities, preoperative pain, and acute postoperative pain (Althaus et al. 2012, VanDenKerkhof et al. 2013). Intraoperative nerve damage and the extent of surgery are also important risk factors (Katz and Seltzer 2009). In fact, many patients with persistent postsurgical pain present with characteristic symptoms of neuropathic pain in the affected area (Kehlet et al. 2006).There is a scarcity of data on persistent postsurgical pain after orthopedic surgery. To our knowledge, previous studies focusing on persistent postsurgical pain in orthopedic patients have concerned mainly amputation or hip or knee replacement (Nikolajsen et al. 2006, Lundblad et al. 2008, Beswick et al. 2012, Liu et al. 2012, Jansen et al. 2014). Trials of shoulder replacement surgery have more commonly reported pain relief, or a composite score including pain, rather than the prevalence of pain at follow-up. There has been very little research on predictive factors for persistent postsurgical pain following shoulder replacement, but the general outcome has been shown to be associated with diagnosis and prosthesis type (Radnay et al. 2007, Fevang et al. 2013) and with previous shoulder surgery, age, and preoperative Short Form-36 mental score and DASH functional score (Simmen et al. 2008). Identification of subgroups at increased risk is important in order to establish interventions to prevent or minimize the impact of persistent postsurgical pain.We investigated the prevalence of, the characteristics of, and risk factors for persistent pain 1–2 years after more than 500 shoulder replacements performed in Denmark.     

Fast-track revision knee arthroplasty. A feasibility study

Background and purpose

Fast-track surgery has reduced the length of hospital stay (LOS), morbidity, and convalescence in primary hip and knee arthroplasty (TKA). We assessed whether patients undergoing revision TKA for non-septic indications might also benefit from fast-track surgery.

Methods

29 patients were operated with 30 revision arthroplasties. Median age was 67 (34–84) years. All patients followed a standardized fast-track set-up designed for primary TKA. We determined the outcome regarding LOS, morbidity, mortality, and satisfaction.

Results

Median LOS was 2 (1–4) days excluding 1 patient, who was transferred to another hospital for logistical reasons (10 days). None of the patients died within 3 months, and 3 patients were re-admitted (2 for suspicion of DVT, which was not found, and 1 for joint mobilization). Patient satisfaction was high.

Interpretation

Patients undergoing revision TKA for non-septic reasons may be included in fast-track protocols. Outcome appears to be similar to that of primary TKA regarding LOS, morbidity, and satisfaction. Our findings call for larger confirmatory studies and studies involving other indications (revision THA, 1-stage septic revisions).For more than a decade, favorable outcomes following fast-track protocols rather than more conventional hospital stays have been reported from numerous studies on primary THA and TKA. In the last few years, outcomes have been further improved, mainly due to improved multimodal opioid-sparing analgesia and early mobilization, allowing patients to fulfill functional discharge criteria within 2–3 days (Husted et al. 2008, 2010 a,b,c,d, Larsen et al. 2008 a,b,c, 2009, Andersen et al. 2009, Barbieri et al. 2009, Rotter et al. 2010). The addition of local infiltration analgesia (LIA) has improved early analgesia and facilitated early recovery, allowing patients to ambulate with full weight bearing within 2–3 hours of surgery (Andersen et al. 2008 a,b, 2009, Holm et al. 2010).So far, however, no one has reported the potential benefits of the fast-track methodology (including multimodal opioid-sparing analgesia, perioperative LIA, and early mobilization) for revision TKA, with its more extensive surgical trauma leading to a corresponding increase in the surgical stress responses. We therefore investigated the feasibility of our well-documented fast-track primary TKA program on a consecutive cohort of revision TKA patients.     

Hospital volume affects outcome after total knee arthroplasty: A nationwide registry analysis of 80 hospitals and 59,696 replacements

ResultsThe greater the volume of the hospital, the shorter was the average LOS and LUIC. Smaller hospital volume was not unambiguously associated with increased revision, re-admission, or MUA rates. The smaller the annual hospital volume, the more often patients were discharged home.InterpretationLOS and LUIC ought to be shortened in lower-volume hospitals. There is potential for a reduction in length of stay in extended institutional care facilities.Total knee replacement (TKR) is one of the most common orthopedic procedures, and it is expected to increase markedly in volume (Kurtz et al. 2007). Due to the potentially severe complications and the high economic impact of the procedure, efforts to minimize the risks and optimize perioperative efficiency are important.It has been suggested that increased hospital volume and reduction in length of stay (LOS) at the operating hospital after TKR are related, but there is no consensus (Yasunaga et al. 2009, Marlow et al. 2010, Paterson et al. 2010, Bozic et al. 2010, Styron et al. 2011). In addition, results on the association of hospital volume with re-admission rates (Soohoo et al. 2006b, Judge et al. 2006, Bozic et al. 2010, Cram et al. 2011) and revision risk have been inconclusive (Shervin et al. 2007, Manley et al. 2009, Bozic et al. 2010, Paterson et al. 2010). No-one has tried to study the association between length of uninterrupted institutional care (LUIC), incidence of manipulation under anesthesia (MUA) after TKR, and hospital volume.By combining 5 national-level registries, we examined possible associations between hospital volume and LOS, LUIC, discharge disposition, number of re-admissions within 14 and 42 days, MUA, and revisions after TKR for all knee arthroplasties performed in Finland between 1998 and 2010.     

Metal-backed versus all-polyethylene tibial components in primary total knee arthroplasty

Background and purpose

The choice of either all-polyethylene (AP) tibial components or metal-backed (MB) tibial components in total knee arthroplasty (TKA) remains controversial. We therefore performed a meta-analysis and systematic review of randomized controlled trials that have evaluated MB and AP tibial components in primary TKA.

Methods

The search strategy included a computerized literature search (Medline, EMBASE, Scopus, and the Cochrane Central Register of Controlled Trials) and a manual search of major orthopedic journals. A meta-analysis and systematic review of randomized or quasi-randomized trials that compared the performance of tibial components in primary TKA was performed using a fixed or random effects model. We assessed the methodological quality of studies using Detsky quality scale.

Results

9 randomized controlled trials (RCTs) published between 2000 and 2009 met the inclusion quality standards for the systematic review. The mean standardized Detsky score was 14 (SD 3). We found that the frequency of radiolucent lines in the MB group was significantly higher than that in the AP group. There were no statistically significant differences between the MB and AP tibial components regarding component positioning, knee score, knee range of motion, quality of life, and postoperative complications.

Interpretation

Based on evidence obtained from this study, the AP tibial component was comparable with or better than the MB tibial component in TKA. However, high-quality RCTs are required to validate the results.The design of the tibial component is an important factor for implant failure in total knee arthroplasty (TKA) (Pagnano et al. 1999, Forster 2003, Gioe et al. 2007b, Willie et al. 2008, Garcia et al. 2009, KAT Trial Group 2009). The metal-backed (MB) design of tibial component has become predominant in TKA because it is thought to perform better than the all-polyethylene (AP) design (Muller et al. 2006, Gioe et al. 2006, 2007a,b). In theory, the MB tibial component reduces bending strains in the stem, reduces compressive stresses in the cement and cancellous bone beneath the baseplate (especially during asymmetric loading), and distributes load more evenly across the interface (Bartel et al. 1982, 1985, Taylor et al. 1998). However, critics of the MB tibial component claim that there are expensive implant costs, reduced polyethylene thickness with the same amount of bone resection, backside wear, and increased tensile stresses at the interface during eccentric loading (Bartel et al. 1982, 1985, Pomeroy et al. 2000, Rodriguez et al. 2001, Li et al. 2002, Muller et al. 2006, Blumenfeld and Scott 2010, Gioe and Maheshwari 2010).In the past decade, several randomized controlled trials (RCTs) have been performed to assess the effectiveness of the MB tibial component (Adalberth et al. 2000, 2001, Gioe and Bowman 2000, Norgren et al. 2004, Hyldahl et al. 2005a, b, Muller et al. 2006, Gioe et al. 2007, Bettinson et al. 2009, KAT Trial Group 2009). However, data have not been formally and systematically analyzed using quantitative methods in order to determine whether the MB tibial component is indeed optimal for patients in TKA. In this study, we wanted (1) to determine the scientific quality of published RCTs comparing the AP and MB tibial components in TKA using Detsky score (Detsky et al. 1992) and (2) to conduct a meta-analysis and systematic review of all published RCTs that have compared the effects of AP and MB tibial components on the radiographic and clinical outcomes of TKA.     

More accurate component alignment in navigated total knee arthroplasty has no clinical benefit at 5-year follow-up

Background and purpose

Computer navigation in total knee arthroplasty is somewhat controversial. We have previously shown that femoral component positioning is more accurate with computed navigation than with conventional implantation techniques, but the clinical impact of this is unknown. We now report the 5-year outcome of our previously reported 2-year outcome study.

Methods

78 of initially 84 patients (80 of 86 knees) were clinically and radiographically reassessed 5 (5.1–5.9) years after conventional, image-based, and image-free total knee arthroplasty. The methodology was identical to that used preoperatively and at 2 years, including the Knee Society score (KSS) and the functional score (FS), and AP and true lateral standard radiographs.

Results

Although a more accurate femoral component positioning in the navigated groups was obtained, clinical outcome, number of reoperations, KSS, FS, and range of motion were similar between the groups.

Interpretation

The increased costs and time for navigated techniques did not translate into better functional and subjective medium-term outcome compared to conventional techniques.Abnormal wear patterns and component loosening are mainly results of component malalignment and complications of the extensor mechanism, the most common reasons for early failure of TKA (Ritter et al. 1994, Rand et al. 2003, Vince 2003, Bathis et al. 2004). It has been suggested that a varus or valgus malalignment of more the 3° leads to faster wear and debris, followed by early failure of TKA (Ecker et al. 1987, Archibeck and White 2003, Nizard et al. 2004).Several surgical navigation systems for TKA have been introduced to optimize component positioning (Delp et al. 1998, DiGioia et al. 1998, Krackow et al. 1999). It has been shown that navigation provides a more precise component positioning and fewer outliers (Bathis et al. 2004, Nabeyama et al. 2004, Stockl et al. 2004, Victor and Hoste 2004, Anderson et al. 2005, Zumstein et al. 2006). Nevertheless, comparing computer-navigated total knee arthroplasty with conventional implantation techniques, there is no evidence in the current literature of any significant improvement in clinical outcome and in component loosening (Bathis et al. 2004, Jenny et al. 2005, Yau et al. 2005, Bonutti et al. 2008, Molfetta and Caldo 2008).In a prospective study involving 86 patients in 3 different groups (image-based navigation, image-free navigation, and conventional), we showed that femoral component positioning was more accurate with navigation than with conventional implantation techniques, but tibial positioning showed similar results (Zumstein et al. 2006).Although other medium-term data on navigated total knee arthroplasty have already been reported (Ishida et al. 2011, Schmitt et al. 2011), there has been no prospective cohort series with reporting of the clinical, functional, and radiographic outcome with all 3 techniques: image-based navigated, image-free navigated, or conventional TKA. We therefore determined the clinical, functional, and radiographic 5-year results after each of the 3 techniques.     

PCR-hybridization after sonication improves diagnosis of implant-related infection

Purpose

We wanted to improve the diagnosis of implant-related infection using molecular biological techniques after sonication.

Methods

We studied 258 retrieved implant components (185 prosthetic implants and 73 osteosynthesis implants) from 126 patients. 47 patients had a clinical diagnosis of infection (108 components) and 79 patients did not (150 components). The fluids from sonication of retrieved implants were tested in culture and were also analyzed using a modified commercial PCR kit for detection of Gram-positive and Gram-negative bacteria (GenoType BC; Hain Lifescience) after extraction of the DNA.

Results

38 of 47 patients with a clinical diagnosis of infection were also diagnosed as being infected using culture and/or PCR (35 by culture alone). Also, 24 patients of the 79 cases with no clinical diagnosis of infection were identified microbiologically as being infected (4 by culture, 16 by PCR, and 4 by both culture and PCR). Comparing culture and PCR, positive culture results were obtained in 28 of the 79 patients and positive PCR results were obtained in 35. There were 21 discordant results in patients who were originally clinically diagnosed as being infected and 28 discordant results in patients who had no clinical diagnosis of infection.

Interpretation

For prosthetic joint infections and relative to culture, molecular detection can increase (by one tenth) the number of patients diagnosed as having an infection. Positive results from patients who have no clinical diagnosis of infection must be interpreted carefully.Management of orthopedic implant-related infections starts with a proper etiological diagnosis, which is required for specific antibiotic treatment. Different approaches are used to obtain such a diagnosis (Trampuz et al. 2006, Del Pozo and Patel 2009) and these must take into account the importance of the development of bacterial biofilms in the pathogenesis and management of implant-related infections (Trampuz et al. 2003, 2006, Costerton 2005).The use of low-intensity ultrasound that releases biofilms is an alternative to classical culture methods from implants, and several protocols have been developed for this purpose (Trampuz et al. 2007, Dora et al. 2008, Esteban et al. 2008, Piper et al. 2009, Achermann et al. 2010). In these reports, the use of sonication of retrieved implants was reported to have similar sensitivity to or higher sensitivity than conventional techniques. Nevertheless, there are still patients with a clinical diagnosis of infection and negative cultures (Berbari et al. 2007). Previous use of antibiotics has been implicated as one of the main causes of this problem (Trampuz et al. 2007), but other causes are also possible. To solve the problem, molecular biological techniques have been proposed in order to obtain faster and more accurate results than conventional culture (Tunney et al. 1999, Sauer et al. 2005, Dempsey et al. 2007, Fihman et al. 2007, Moojen et al. 2007, Gallo et al. 2008, Kobayashi et al. 2008, Vandercam et al. 2008, De Man et al. 2009, Piper et al. 2009, Achermann et al. 2010, Riggio et al. 2010, Marin et al. 2012). Most of these reports were based on protocols that were developed in-house, which are difficult to integrate into clinical microbiology routines, even though they may give good results. Recently, however, commercial kits have been designed to work under common routine laboratory conditions. Here, we describe a study on the diagnosis of infection in a broad range of orthopedic implant-related infections, comparing conventional culture with detection of microbial DNA using a commercial kit—in both cases after sonication of retrieved implants.     

Intraarticular location predicts cartilage filling and subchondral bone changes in a chondral defect

Background and purpose

The natural history of, and predictive factors for outcome of cartilage restoration in chondral defects are poorly understood. We investigated the natural history of cartilage filling subchondral bone changes, comparing defects at two locations in the rabbit knee.

Animals and methods

In New Zealand rabbits aged 22 weeks, a 4-mm pure chondral defect (ICRS grade 3b) was created in the patella of one knee and in the medial femoral condyle of the other. A stereo microscope was used to optimize the preparation of the defects. The animals were killed 12, 24, and 36 weeks after surgery. Defect filling and the density of subchondral mineralized tissue was estimated using Analysis Pro software on micrographed histological sections.

Results

The mean filling of the patellar defects was more than twice that of the medial femoral condylar defects at 24 and 36 weeks of follow-up. There was a statistically significant increase in filling from 24 to 36 weeks after surgery at both locations.The density of subchondral mineralized tissue beneath the defects subsided with time in the patellas, in contrast to the density in the medial femoral condyles, which remained unchanged.

Interpretation

The intraarticular location is a predictive factor for spontaneous filling and subchondral bone changes of chondral defects corresponding to ICRS grade 3b. Disregarding location, the spontaneous filling increased with long-term follow-up. This should be considered when evaluating aspects of cartilage restoration.Focal articular cartilage injuries of the knee are common (Hjelle et al. 2002, Aroen et al. 2004) and they can impair patients'' quality of life as much as severe osteoarthritis (Heir et al. 2010). The literature concerning the natural history of focal cartilage defects in patients, and the intrinsic factors affecting it, is limited (Linden 1977, Messner and Gillquist 1996, Drogset and Grontvedt 2002, Shelbourne et al. 2003, Loken et al. 2010). In experimental studies evaluating cartilage restoration in general, the importance of intrinsic factors such as the depth and size of the lesion and the time from when the lesion was made to evaluation have been emphasized (Shapiro et al. 1993, Hunziker 1999, Lietman et al. 2002). Which part of the joint is affected and whether or not the defect is weight-bearing are also of interest (Hurtig 1988, Frisbie et al. 1999). Most of these studies have, however, concerned defects penetrating the subchondral mineralized tissues corresponding to ICRS grade 4 (Brittberg and Winalski 2003). Access to bone marrow elements in these defects might be one of the strongest predictive factors for filling of the defect, making the importance of other factors difficult to evaluate (Hunziker 1999).In experimental studies on pure chondral defects that do not penetrate the subchondral mineralized tissues, corresponding to ICRS grade 3b (Brittberg and Winalski 2003), the type of animal studied, the size of the lesion, and the location of the defects vary, and there is limited data on the influence of these parameters on outcome (Breinan et al. 2000). The information on spontaneous filling comes mainly from observations of untreated defects serving as controls (Grande et al. 1989, Brittberg et al. 1996, Breinan et al. 1997, 2000, Frisbie et al. 1999, 2003, Dorotka et al. 2005) and the information on subchondral bone changes is even more limited (Breinan et al. 1997, Frisbie et al. 1999). Although most human focal cartilage lesions are located on the medial femur condyle (Aroen et al. 2004), there have been few experimental studies involving untreated ICRS grade 3b defects on the medial femur condyle (Dorotka et al. 2005). According to a PubMed search, the rabbit knee is the most widely used experimental animal model for cartilage restoration (Årøen 2005). The locations of ICRS grade 3 chondral defects in the rabbit knee evaluated for spontaneous changes have included the patella (Grande et al. 1989, Brittberg et al. 1996) and, in one study, defects at the distal surface of the femur (Mitchell and Shepard 1976). The latter report did not, however, include quantitative data.To our knowledge, the influence of the intraarticular location on the outcome of cartilage restoration and subchondral bone changes has not been thoroughly studied. Thus, the main purpose of our study was to test the hypothesis that the intraarticular location influences the spontaneous filling of a chondral defect that does not penetrate the subchondral bone. Secondly, we wanted to evaluate whether the intraarticular location would influence changes in the subchondral bone and degenerative changes as evaluated from macroscopic appearance and proteoglycan content of synovial fluid (Messner et al. 1993a).     

Cancer incidence and cause-specific mortality in patients with metal-on-metal hip replacements in Finland: A population-based study with a mean follow-up of 4.6 (1–11) years

Background and purpose

Metal-on-metal hip implants have been widely used, especially in the USA, Australia, England and Wales, and Finland. We assessed risk of death and updated data on the risk of cancer related to metal-on-metal hip replacements.

Patients and methods

A cohort of 10,728 metal-on-metal hip replacement patients and a reference cohort of 18,235 conventional total hip replacement patients were extracted from the Finnish Arthroplasty Register for the years 2001–2010. Data on incident cancer cases and causes of death until 2011 were obtained from the Finnish Cancer Registry and Statistics Finland. The relative risk of cancer and death were expressed as standardized incidence ratio (SIR) and standardized mortality ratio (SMR). SIR/SIR ratios and SMR/SMR ratios, and Poisson regression were used to compare the cancer risk and the risk of death between cohorts.

Results

The overall risk of cancer in the metal-on-metal cohort was not higher than that in the non-metal-on-metal cohort (RR = 0.91, 95% CI: 0.82–1.02). The risk of soft-tissue sarcoma and basalioma in the metal-on-metal cohort was higher than in the non-metal-on-metal cohort (SIR/SIR ratio = 2.6, CI: 1.02–6.4 for soft-tissue sarcoma; SIR/SIR ratio = 1.3, CI: 1.1–1.5 for basalioma). The overall risk of death in the metal-on-metal cohort was less than that in the non-metal-on-metal cohort (RR = 0.78, CI: 0.69–0.88).

Interpretation

The overall risk of cancer or risk of death because of cancer is not increased after metal-on-metal hip replacement. The well-patient effect and selection bias contribute substantially to the findings concerning mortality. Arthrocobaltism does not increase mortality in patients with metal-on-metal hip implants in the short term. However, metal-on-metal hip implants should not be considered safe until data with longer follow-up time are available.Metal-on-metal hip implants have been widely used, especially in the USA, Australia, England and Wales, and Finland (AOANJRR 2010, NJR 2011, Cohen 2012, Seppänen et al. 2012). The theoretical health risks related to chronically elevated blood metal ion concentrations induced by abnormal wear and corrosion of the metal-on-metal implants—apart from local symptoms around the failing implant—include systemic symptoms of poisoning (Steens et al. 2006, Oldenburg et al. 2009, Rizzetti et al. 2009, Tower 2010, 2012, Mao et al. 2011, Sotos and Tower 2013, Zyviel et al. 2013) and carcinogenesis (Mäkelä et al. 2012, Smith et al. 2012, Brewster et al. 2013). Systemic metal ion toxicity cases due to a failed hip replacement are rare. However, there have been several recent reports of systemic cobalt toxicity following revision of fractured ceramic components, and also in patients with a failed metal-on-metal hip replacement (Steens et al. 2006, Oldenburg et al. 2009, Rizzetti et al. 2009, Tower 2010, 2012, Mao et al. 2011, Sotos and Tower 2013, Zyviel et al. 2013). Possible clinical findings include fatigue, weakness, hypothyroidism, cardiomyopathy, polycythemia, visual and hearing impairment, cognitive dysfunction, and neuropathy. Fatal cardiomyopathy due to systemic cobalt toxicity after hip replacement has been reported (Zyviel et al. 2013).Metal debris from hip replacement may be associated with chromosomal aberrations and DNA damage (Case et al. 1996, Bonassi et al. 2000, Daley et al. 2004). However, the risk of cancer is not increased after conventional metal-on-polyethylene total hip replacement or after first-generation metal-on-metal total hip arthroplasty (Visuri et al. 1996, 2010a). The short-term overall cancer risk after modern metal-on-metal hip arthroplasty is not increased either (Mäkelä et al. 2012, Smith et al. 2012, Brewster et al. 2013). However, recent linkage studies of overall cancer risk are based on hospital episode statistics, which may have less quality assurance than cancer registry data (Smith et al. 2012, Brewster et al. 2013). Annual updating of cancer registry data concerning the metal-on-metal issue is advisable.In this paper, we update our earlier published results on risk of cancer (Mäkelä et al. 2012) and give an assessment of the overall and cause-specific mortality in primary metal-on-metal and non-metal-on-metal hip replacement patients who were operated on from 2001 to 2010, by combining data from the Finnish Arthroplasty Register, the Population Register Centre, and the Finnish Cancer Registry. The reason for this early updating of the cancer data was to be able to detect a cancerogenic effect of metal-on-metal implants as early as possible.     

Dissatisfied patients after total knee arthroplasty: A registry study involving 114 patients with 8–13 years of follow-up

Background and purpose

In 2003, an enquiry by the Swedish Knee Arthroplasty Register (SKAR) 2–7 years after total knee arthroplasty (TKA) revealed patients who were dissatisfied with the outcome of their surgery but who had not been revised. 6 years later, we examined the dissatisfied patients in one Swedish county and a matched group of very satisfied patients.

Patients and methods

118 TKAs in 114 patients, all of whom had had their surgery between 1996 and 2001, were examined in 2009–2010. 55 patients (with 58 TKAs) had stated in 2003 that they were dissatisfied with their knees and 59 (with 60 TKAs) had stated that they were very satisfied with their knees. The patients were examined clinically and radiographically, and performed functional tests consisting of the 6-minute walk and chair-stand test. All the patients filled out a visual analog scale (VAS, 0–100 mm) regarding knee pain and also the Hospital and Anxiety and Depression scale (HAD).

Results

Mean VAS score for knee pain differed by 30 mm in favor of the very satisfied group (p < 0.001). 23 of the 55 patients in the dissatisfied group and 6 of 59 patients in the very satisfied group suffered from anxiety and/or depression (p = 0.001). Mean range of motion was 11 degrees better in the very satisfied group (p < 0.001). The groups were similar with regard to clinical examination, physical performance testing, and radiography.

Interpretation

The patients who reported poor response after TKA continued to be unhappy after 8–13 years, as demonstrated by VAS pain and HAD, despite the absence of a discernible objective reason for revision.The results of TKA are regarded as being favorable (Robertsson et al. 2000, Kane et al. 2005, Nilsdotter et al. 2009, Carr et al. 2012) with few surgical complications and a revision rate of less than 5% after 10 years (Vessely et al. 2006, Robertsson et al. 2010). Poor outcome after primary TKA, apart from the revision, is between 6% and 14% (Anderson et al. 1996, Hawker et al. 1998, Heck et al. 1998, Robertsson et al. 2000, Robertsson and Dunbar 2001, Brander et al. 2003, Noble et al. 2006, Fisher et al. 2007, Wylde et al. 2008, Kim et al. 2009, Bourne et al. 2010, Scott et al. 2010). The reason for poor outcome after TKA may be related to problems with the knee surgery itself, although it has been suggested that extra-articular causes such as hip disease, spine disorder, vascular disease, or reflex sympathetic dystrophy may contribute. Some studies have suggested that factors not primarily related to structural tissue changes, but of psychological nature instead, may be involved (Wylde et al. 2007, Rolfson et al. 2009).The Swedish Knee Arthroplasty Register (SKAR) registers primary arthroplasties performed in Sweden as well as revisions, and has been estimated to capture 97% of the surgeries performed (SKAR 2012). The SKAR sends questionnaires regarding satisfaction to patients who were operated on during certain time periods (Robertsson et al. 2000, and Dunbar 2001). We used the SKAR to identify patients who had not undergone revision surgery and who were dissatisfied with their outcome 2–7 years after TKA surgery. As a reference we chose an age-, sex-, date-of-surgery-, and hospital-matched control group of highly satisfied patients who were operated during the same period. Our aim was to assess the differences between these 2 patient groups.     

Comparison of flanged and unflanged acetabular cup design: An experimental study using ceramic and cadaveric acetabuli

Background and purpose

Adequate depth of cement penetration and cement mantle thickness is important for the durability of cemented cups. A flanged cup, as opposed to unflanged, has been suggested to give a more uniform cement mantle and superior cement pressurization, thus improving the depth of cement penetration. This hypothesis was tested experimentally.

Materials and methods

The same cup design with and without flange (both without cement spacers) was investigated regarding intraacetabular pressure, cement mantle thickness, and depth of cement penetration. With machine control, the cups were inserted into open-pore ceramic acetabular models (10 flanged, 10 unflanged) and into paired cadaver acetabuli (10 flanged, 10 unflanged) with prior pressurization of the cement.

Results

No differences in intraacetabular pressures during cup insertion were found, but unflanged cups tended to migrate more towards the acetabular pole. Flanged cups resulted in thicker cement mantles because of less bottoming out, whereas no differences in cement penetration into the bone were observed.

Interpretation

Flanged cups do not generate higher cementation pressure or better cement penetration than unflanged cups. A possible advantage of the flange, however, may be to protect the cup from bottoming out, and there is possibly better closure of the periphery around the cup, sealing off the cement-bone interface.The main cause of aseptic loosening is inadequate surgical techniques and inferior prosthetic implants (Herberts and Malchau 2000). Sufficient cement penetration (3–5 mm) into cancellous bone and prevention of bottoming out of the cup, as seen from a uniform cement mantle that is at least 2 mm thick (i.e. cement penetration excluded), have been said to be crucial for cup fixation (Huiskes and Slooff 1981, Noble and Swarts 1983, Schmalzried et al. 1993, Mjöberg 1994, Ranawat et al. 1997, Lichtinger and Muller 1998). A clean bony surface with partly exposed cancellous bone together with cement pressurization before prosthetic implantation improves the depth of cement penetration, thus creating a stronger cement-bone interface (Krause et al. 1982, Rey, Jr. et al. 1987, Mann et al. 1997, Flivik et al. 2006, Abdulghani et al. 2007).Absence of postoperative demarcation at the acetabular cement-bone interface has been related to a reduced risk of aseptic cup loosening (Ranawat et al. 1995, Garcia-Cimbrelo et al. 1997, Ritter et al. 1999, Flivik et al. 2005). The use of a flanged polyethylene cup has demonstrated both less postoperative demarcation at the above interface (Hodgkinson et al. 1993) and less loosening (Garellick et al. 2000). This may be due to its ability to increase cement pressurization at the time of implantation and thereby the depth of cement penetration, though conflicting experimental findings have been reported (Oh et al. 1985, Shelley and Wroblewski 1988, Parsch et al. 2004, Lankester et al. 2007). The previous studies addressing the use of flanged cups have all had cups inserted without prior pressurization of cement, and only Parsch et al. (2004) implanted the cup into a porous material (cadaveric bone).Accordingly, we decided to compare the intraacetabular pressures, cement mantle thickness, and depth of cement penetration obtained using flanged and unflanged cups inserted in an open-pore ceramic acetabular model as well as in paired cadaveric acetabuli, using pressurization of the cement before implantation.