Alendronate prevents femoral periprosthetic bone loss following total hip arthroplasty: prospective randomized double-blind study.

Following total hip arthroplasty (THA), femoral periprosthetic bone undergoes a remodeling process that results in bone loss in its proximal regions that may compromise the long-term outcome of THA. Periprosthetic bone loss mainly occurs during the first postoperative months. The question is whether a postoperative treatment with alendronate is effective in reducing periprosthetic bone loss and which doses and duration of treatment are required. In a 12-month prospective, randomized double-blind study, 51 patients undergoing cementless THA were treated postoperatively either with a daily dose of 20 mg alendronate for 2 months and 10 mg for 2 months thereafter (group I), with 20 mg of alendronate for 2 months and 10 mg for 4 months thereafter (group II), or treated with placebo (group III). Proximal femoral bone mineral density (BMD) was measured with dual-energy X-ray absorptiometry (DEXA) and serum biochemical markers of bone turnover bone specific alkaline phosphatase, osteocalcin, and C-terminal telopeptides (CTX-I) were assayed. Six months of alendronate treatment significantly reduced (p<0.001) bone loss in proximal medial region (-10%) compared with placebo (-26%). All biochemical markers of bone turnover were suppressed by alendronate. These data suggest that alendronate administered for the first 6 postoperative months following THA was effective in preventing early periprosthetic bone loss.     

A randomized trial of hydroxyapatite-coated femoral stems in total hip arthroplasty: a 13-year follow-up

A prospective randomized trial comparing hydroxyapatite (HA)-coated and non-HA-coated femoral total hip arthroplasty components was conducted. Sixty-one consecutive patients undergoing primary hip arthroplasty were randomized to receive an identical femoral component with or without HA. Forty-eight hips were available for review at an average of 13 years and 5 months after surgery. The only femoral stem revised was secondary to femoral fracture after mitral valve area. All femoral stems were well fixed on x-ray with no evidence of loosening. There was no statistically significant difference in the revision rates or in the Harris hip score between the HA vs non-HA-coated groups. This study suggests there is no clinical advantage to the use of a hydroxyapatite coating on the femoral component of this design for primary total hip arthroplasty.     

Sequential changes in periprosthetic bone mineral density following total hip arthroplasty: a 3-year follow-up

 We sequentially measured the periprosthetic bone mineral density (BMD) of the femur after cementless total hip arthroplasty, using dual-energy X-ray absorptiometry, over a 3-year period. The periprosthetic bone was divided into three regions (proximo-medial, middle, and distal to the prosthetic stem). After the insertion of a fully porous coated stem in 21 patients, the BMD was measured within 3 weeks, and 6, 12, 24, and 36 months after surgery. At 6 months, all zones showed a decrease in BMD relative to the BMD within 3 weeks, but subsequently the BMD was unchanged. The lower the BMD within 3 weeks of surgery, or the lower the body weight, the higher the percent loss of BMD at 6 months. Received: September 9, 2002 / Accepted: December 12, 2002 RID="*" ID="*" Offprint requests to: H. Ohta     

Altered load history affects periprosthetic bone loss following cementless total hip arthroplasty

Dual energy x-ray absorptiometry was used to measure periprosthetic, distal femoral, and proximal tibial bone mass in the affected and contralateral limbs of eight patients 10 years after unilateral total hip arthroplasty with a cementless, porous-coated titanium alloy femoral stem. Gait analyses to assess the presence of asymmetries in loading of the lower extremities were also performed 10 years postoperatively. The patients had excellent clinical results and no other significant lower extremity pathology. On the basis of comparison of the affected and unaffected proximal femora, bone loss adjacent to the proximal medial aspect of the femoral stem was determined to be 34% (p < 0.001). However, the patients also had 16% less bone in the ipsilateral proximal tibia (p = 0.003) and 15% less bone in the ipsilateral femur 3 cm distal to the prosthesis (p = 0.007) compared with the contralateral limb. When normalized to the asymmetry in tibial bone mineral content, the estimated proximal medial periprosthetic bone loss was still statistically significant, but the magnitude was reduced from 34 to 17% (p = 0.009). The gait analyses indicated that several measures that influence the loads at the hip and knee joints were reduced in the involved limb compared with the contralateral limb. Furthermore, the bilateral difference in the vertical component of the external force acting on the proximal tibia was correlated with the bilateral difference in tibial bone mineral content (r = 0.80, p = 0.02). These data suggest that two mechanical factors, the local stress-shielding effect of the prosthesis and the global effect of decreased loading of the limb, can both make significant contributions to periprosthetic bone loss. It is apparent that the magnitude of the periprosthetic bone loss related to stress-shielding has been overestimated by as much as 50% in retrospective studies.     

Effect of pamidronate in preventing local bone loss after total hip arthroplasty: a randomized, double-blind, controlled trial.

Acute periprosthetic bone loss occurs after total hip arthroplasty. Bone loss undermines the support of the implant and may contribute to prosthetic failure. At present, there is no established prophylaxis for this process. We studied the effect of a single-dose infusion of 90 mg of pamidronate on early periprosthetic bone mineral density (BMD), biochemical markers of bone turnover, radiological, and clinical outcome in a 26-week, prospective, randomized, double-blinded study of 47 men and women undergoing total hip arthroplasty. Pamidronate therapy led to a significant reduction in bone loss compared with placebo for both the proximal femur and the pelvis (repeated measures analysis of variance [ANOVA]); p = 0.001 and p = 0.01, respectively). Pamidronate therapy was associated with suppression of all biochemical markers of bone turnover compared with placebo (repeated measures ANOVA; p < 0.05 for all comparisons), with the exception of urinary free deoxypyridinoline. Pamidronate did not interfere with the clinical improvement in symptoms after total hip arthroplasty, or radiological outcome, and was not associated with an increase in adverse events. This study provides clinical data on the efficacy and safety of bisphosphonates for the prevention of bone loss after total hip arthroplasty and supports the establishment of larger-scale clinical trials to determine the long-term clinical efficacy of this intervention using implant failure as the primary endpoint.     

Alendronate reduces periprosthetic bone loss after uncemented primary total hip arthroplasty: a prospective randomized study.

Periprosthetic bone loss, especially in the proximal part of the femur, is common after cemented and uncemented total hip arthroplasty (THA). Bone loss can be progressive and, in the extreme, may threaten survival of the prosthesis. To study whether alendronate therapy can reduce bone loss adjacent to prostheses, 13 uncemented primary THA patients were randomized to the study. They received 10 mg alendronate + 500 mg calcium (n = 8) or 500 mg calcium only (n = 5) daily for 6 months follow-up after THA. Periprosthetic bone mineral density (BMD) was measured with dual energy X-ray absorptiometry (DXA). Decreases in periprosthetic BMD in the alendronate-treated group were lower compared with the changes in the calcium-only group in the same regions of interest at the same follow-up time. In the proximal femur, the mean BMD decrease was 17.1% in the calcium-only group, whereas in the alendronate-treated group the decrease was only 0.9% (p = 0.019). The mean periprosthetic BMD change was also significantly different in the total periprosthetic area between the study groups at the end of the follow-up (calcium-only group -9.9% vs. alendronate-treated group -2.6%; p = 0.019). Alendronate therapy led to a significant reduction in periprosthetic bone loss after primary uncemented THA compared with the changes found in patients without therapy. This kind of bone response may improve the support of the prosthesis and may result in better survival of the prosthesis. However, in this study the follow-up time was too short and the study population was too small to make any long-term conclusions as to the prognosis for THA patients treated with alendronate.     

Effect of alendronate on periprosthetic bone loss after total knee arthroplasty: a one-year,randomized, controlled trial of 19 patients

Undesired bone loss around implants is considered to occur mainly because of a stress-shielding phenomenon. Bone surrounding the total knee arthroplasty (TKA) adjusts its mineral density and structure to meet new mechanical demands. Immobilization, in combination with local operative trauma to the bone and soft tissues, has an additional impact on bone loss. The clinical survival of TKA is associated with the quality and quantity of the surrounding bone environment. Poor bone quality and quantity may predispose to aseptic implant loosening and periprosthetic fractures. We investigated the efficacy of oral bisphosphonate (alendronate, Fosamax) with calcium (Calcichew) for the inhibition of early bone mineral density (BMD) loss after TKA in a prospective, randomized, one-year follow-up study. Periprosthetic BMD changes were measured with fan-beam dual-energy X-ray absorptiometry (DXA) in 19 patients with knee osteoarthrosis. Patients (n = 8) treated with 10 mg alendronate and 500 mg calcium daily maintained distal femoral BMD values close to the baseline values (P > 0.04), while patients receiving only 500 mg of calcium daily (n = 11) showed significant bone loss during the one-year follow-up (P < 0.015). The treatment groups differed significantly in metaphyseal anterior, posterior, diaphyseal, and metaphyseal total regions of interest (ROIs) (repeated measures ANOVA analyses, P = 0.019, P = 0.010, P = 0.022, and P = 0.024, respectively). Our results indicate that oral alendronate reduces early postoperative periprosthetic bone loss significantly. This therapeutic strategy may improve the results and longevity of primary total knee arthroplasties.     

Treatment of periprosthetic femoral fractures following total hip arthroplasty with femoral component revision

BACKGROUND: Revision total hip arthroplasty is indicated for most periprosthetic fractures that occur around the stem of the femoral implant. The purpose of the present study was to assess the results and complications of revision total hip arthroplasty for the treatment of periprosthetic femoral fractures. METHODS: We evaluated 118 hips in 116 patients who underwent revision total hip arthroplasty because of an acute Vancouver type-B periprosthetic femoral fracture. The femoral implant used for the revision was a cemented stem in forty-two hips, a proximally porous-coated uncemented stem in twenty-eight, an extensively porous-coated stem in thirty, and an allograft-prosthesis composite or tumor prosthesis in eighteen. The mean duration of follow-up was 5.4 years. RESULTS: Kaplan-Meier analysis demonstrated that the probability of survival was 90% at five years and 79.2% at ten years with revision or removal of the femoral implant for any reason as the end point. Sixteen femoral components were rerevised: ten were rerevised because of loosening; three, because of loosening in association with a fracture nonunion; two, because of recurrent dislocation; and one, because of a new periprosthetic fracture. Additionally, six femoral implants were resected because of deep infection (five) or prosthetic loosening (one). Radiographs of the ninety-six hips with a surviving implant showed that twenty-one had evidence of loosening of the femoral implant, four had a nonunion of the femoral fracture, and two had both a nonunion and loosening of the femoral implant. CONCLUSIONS: Revision total hip arthroplasty for the treatment of a periprosthetic fracture around the stem of the femoral implant successfully restored function for most patients. The greatest long-term problems were prosthetic loosening and fracture nonunion. Better results were seen when an uncemented, extensively porous-coated stem was used.     

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.     

No positive effect of autologous platelet gel after total knee arthroplasty: A double-blind randomized controlled trial: 102 patients with a 3-month follow-up

Background and purpose Activated platelets release a cocktail of growth factors, some of which are thought to stimulate repair. We investigated whether the use of autologous platelet gel (PG) in total knee arthroplasty (TKA) would improve wound healing and knee function, and reduce blood loss and the use of analgesics.Patients and methods 102 patients undergoing TKA were randomly assigned to a PG group (n = 50) or to a control (C) group (n = 52). The primary analysis was based on 73 participants (PG: 32; C: 41) with comparison of postoperative wound scores, VAS, WOMAC, knee function, use of analgesics, and the pre- and postoperative hemoglobin values after a follow-up of 3 months. 29 participants were excluded due to insufficient data.Results The characteristics of the protocol-compliant patients were similar to those of the patients who were excluded. Analysis was per protocol and focused on the remaining 73 patients. At baseline and after 3 months of follow-up, there were no statistically significant differences between both groups regarding age, height, weight, sex, side of operation, platelet count, hemoglobin values, severity of complaints (WOMAC), and level of pain.Interpretation In our patients undergoing TKA, application of PG to the wound site did not promote wound healing. Also, we found that PG had no effect on pain, knee function, or hemoglobin values.     

Perioperative local infiltration anesthesia with ropivacaine has no effect on postoperative pain after total hip arthroplasty: A randomized,double-blind,placebo-controlled trial with 116 patients

Background and purpose — The local infiltration analgesia (LIA) technique has been widely used to reduce opioid requirements and to improve postoperative mobilization following total hip arthroplasty (THA). However, the evidence for the efficacy of LIA in THA is not yet clear. We determined whether single-shot LIA in addition to a multimodal analgesic regimen would reduce acute postoperative pain and opioid requirements after THA.Patients and methods — 116 patients undergoing primary THA under spinal anesthesia were included in this randomized, double-blind, placebo-controlled trial. All patients received oral opioid-sparing multimodal analgesia: etoricoxib, acetaminophen, and glucocorticoid. The patients were randomized to receive either 150 mL ropivacaine (2 mg/mL) and 0.5 mL epinephrine (1 mg/mL) or 150 mL 0.9% saline. Rescue analgesic consisted of morphine and oxycodone as needed. The primary endpoint was pain during mobilization in the recovery unit. Secondary endpoints were pain during mobilization on the day after surgery and total postoperative opioid requirements on the first postoperative day.Results — The levels of pain during mobilization—both in the recovery unit and on the day after surgery—and consumption of opioids on the first postoperative day were similar in the 2 groups.Interpretation — LIA did not provide any extra analgesic effect after THA over and above that from the multimodal analgesic regimen used in this study.Implementation of accelerated clinical pathways based on the fast-track principles reduces morbidity and enhances recovery for patients undergoing THA (Kehlet and Wilmore 2008). One of the key prerequisites is optimized pain relief, allowing early postoperative mobilization (Kehlet and Wilmore 2008). This requires that the pain treatment should be safe and effective, both at rest and during activity (Srikandarajah and Gilron 2011).The concept of multimodal analgesia for acute postoperative pain is to combine analgesics with additive or synergistic effects, which is meant to reduce the use of—and the adverse effects of—opioids and to allow early mobilization (Kehlet and Dahl 1993, Kehlet et al. 1999, Buvanendran and Kroin 2009). Multimodal analgesia in THA usually includes analgesics such as opioids, gabapentin, NSAIDs, acetaminophen, glucocorticoids, and local infiltration (Kardash et al. 2008, Kerr and Kohan 2008, Toms et al. 2008, Fredheim et al. 2011, Maund et al. 2011, Zhang et al. 2011).Kerr and Kohan (2008) reported reduced opioid requirements and reduced hospital stay with the use of LIA consisting of ropivacaine and NSAIDs. However, trials investigating the effect of ropivacaine in LIA have not determined whether ropivacaine alone gives similar improvements following THA (Lunn et al. 2011, Dobie et al. 2012, Zoric et al. 2014). Studies using LIA have often combined different analgesics (Kerr and Kohan 2008, Kuchalik et al. 2013), and this complicates interpretation of the results regarding the extent to which ropivacaine alone contributes to the outcome.Various studies have shown that LIA does not provide any additional analgesic benefit or reduce opioid consumption after THA (Lunn et al. 2011, Dobie et al. 2012, Solovyova et al. 2013, Zoric et al. 2014), and some authors do not recommend LIA in addition to a multimodal analgesic regimen after THA (Andersen et al. 2011, Lunn et al. 2011). Other studies have shown that LIA reduces the opioid consumption (Andersen et al. 2007, Kerr and Kohan 2008, Busch et al. 2010, Murphy et al. 2012, Kuchalik et al. 2013) and shortens the hospital stay after THA (Kerr and Kohan 2008, Scott et al. 2012) The results are thus conflicting, and the role of LIA in THA surgery still needs to be clarified.We investigated whether a single-shot LIA with ropivacaine in addition to a multimodal analgesic regimen would reduce acute postoperative pain and opioid requirements after THA.     

Cement-in-cement stem revision for Vancouver type B periprosthetic femoral fractures after total hip arthroplasty: A 3-year follow-up of 23 cases

Background and purpose Revision surgery for periprosthetic femoral fractures around an unstable cemented femoral stem traditionally requires removal of existing cement. We propose a new technique whereby a well-fixed cement mantle can be retained in cases with simple fractures that can be reduced anatomically when a cemented revision is planned. This technique is well established in femoral stem revision, but not in association with a fracture.Patients and methods We treated 23 Vancouver type B periprosthetic femoral fractures by reducing the fracture and cementing a revision stem into the pre-existing cement mantle, with or without supplementary fixation.Results 3 patients died in the first 6 months for reasons unrelated to surgery. In addition, 1 was too frail to attend follow-up and was therefore excluded from the study, and 1 patient underwent revision surgery for a nonunion. The remaining 18 cases all healed with radiographic union after an average time of 4.4 (2–11) months. There was no sign of loosening or subsidence of the revision stems within the old cement mantle in any of these cases at the most recent follow-up after an average of 3 (0.3–9) years.Interpretation Our results support the use of the cement-in-cement revision in anatomically reducible periprosthetic fractures with a well-preserved pre-existing cement mantle. This technique is particularly useful for the elderly patient and for those who are not fit for prolonged surgical procedures.     

No effect of fibrin sealant on drain output or functional recovery following simultaneous bilateral total knee arthroplasty: A randomized,double-blind,placebo-controlled study

We determined proprioception in replaced and unreplaced arthrotic knees by measuring threshold levels for the perception of passive knee motion. In addition, results of these proprioception measurements were compared with the clinical outcomes in patients with a total knee arthroplasty. Threshold detection levels were significantly higher in the replaced than in the unreplaced knees. Moreover, detection-failure rates were significantly higher in the replaced knees as well. In contrast to this diminished movement sense in the replaced knees, clinical examination of these knees showed good or excellent outcome in all cases. A correlation between the clinical outcome and the ability to perceive passive motion in either patient group could not be found. We hypothesize that our findings may be due to the operative removal of intraarticular receptor-rich tissue that is affected by arthrosis. This would not only contribute to marked clinical improvements but also to a significant decrease in proprioception.     

Changes of femoral periprosthetic bone mineral density 6 years after treatment with alendronate following total hip arthroplasty

Earlier osteodensitometric results of femoral periprosthetic bone showed that postoperative antiresorptive treatment with alendronate following total hip arthroplasty (THA) reduces the periprosthetic bone loss that commonly occurs in the first months after surgery. However, whether alendronate can prevent periprosthetic bone loss over the long term, or if bone loss occurs after discontinuing alendronate is unknown. Femoral periprosthetic bone mineral density (BMD) was assessed in 49 patients 6 years after cementless total hip arthroplasty using dual energy X‐ray absorptiometry. Twenty‐nine patients were treated postoperatively with alendronate and 20 control patients received no treatment. All patients were followed up at 12 months after surgery in a prospective randomized study. The bone mineral density was evaluated in 7 regions of interest according to the Gruen protocol. Six years after total hip arthroplasty, no significant changes were detected in femoral periprosthetic BMD when compared with results at 1 year, and the bone loss in patients with postoperative alendronate treatment was still significantly less than those without treatment. These results suggest that the prevention of femoral periprosthetic bone loss following THA achieved by postoperative antiresorptive treatment with alendronate is of long‐standing effect, and further bone loss does not occur after the first postoperative year. © 2008 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 27:183–188, 2009     

Restoration of proximal periprosthetic bone loss by denosumab in cementless total hip arthroplasty

Summary

Denosumab contributed to the restoration of proximal periprosthetic bone loss around the femoral stem that were measured using a DEXA, especially in zone 7, at 1 year after cementless THA in elderly osteoporotic patients.

Introduction

Although bone quality is an important issue in elderly osteoporotic patients who underwent total hip arthroplasty (THA) with a cementless stem, periprosthetic bone mineral density (BMD) in the proximal femur has been reported to be decreased by 15–40% postoperatively. Some authors have examined the use of several types of bisphosphonates to prevent decreases in BMD in the proximal femur after cementless THA; however, few reports have demonstrated success in restoring BMD in the proximal medial femoral bone, such as zone 7.

Methods

We conducted prospective study comparing patients who underwent cementless THA administered with denosumab (10 patients) and without denosumab (10 patients). BMD around the femoral stem were measured using a DEXA immediately after surgery, and at 6 months and at 1 year after surgery. No difference was found between the two groups referred to the patient’s demographic data.

Results

We found that denosumab displayed definitive effects in increasing the % change in periprosthetic BMD at zone 7 by an average of 7.3% in patients with cementless THA, compared to control group who were given only vitamin D.

Conclusion

Denosumab is one of a number of anti-osteoporotic agents to have a definitive effect on the restoration of proximal periprosthetic bone loss, especially in zone 7, after cementless THA. Denosumab contributed to the restoration of decreased periprosthetic BMD to normal levels. As the decrease in BMD in the proximal femur after THA is considered to be apparent at 6–12 months after surgery, it is believed that prevention of the deterioration of bone quality is important in the proximal femur immediately after cementless THA for elderly female patients with osteoporosis.