Early migration of tibial components is associated with late revision

Purpose We performed two parallel systematic reviews and meta-analyses to determine the association between early migration of tibial components and late aseptic revision.

Methods One review comprised early migration data from radiostereometric analysis (RSA) studies, while the other focused on revision rates for aseptic loosening from long-term survival studies. Thresholds for acceptable and unacceptable migration were determined according to that of several national joint registries: < 5% revision at 10 years.

Results Following an elaborate literature search, 50 studies (involving 847 total knee prostheses (TKPs)) were included in the RSA review and 56 studies (20,599 TKPs) were included in the survival review. The results showed that for every mm increase in migration there was an 8% increase in revision rate, which remained after correction for age, sex, diagnosis, hospital type, continent, and study quality. Consequently, migration up to 0.5 mm was considered acceptable during the first postoperative year, while migration of 1.6 mm or more was unacceptable. TKPs with migration of between 0.5 and 1.6 mm were considered to be at risk of having revision rates higher than 5% at 10 years.

Interpretation There was a clinically relevant association between early migration of TKPs and late revision for loosening. The proposed migration thresholds can be implemented in a phased, evidence-based introduction of new types of knee prostheses, since they allow early detection of high-risk TKPs while exposing only a small number of patients.     

Early proximal migration of cups is associated with late revision in THA

Background and purpose The association between excessive early migration of acetabular cups and late aseptic revision has been scantily reported. We therefore performed 2 parallel systematic reviews and meta-analyses to determine the association between early migration of acetabular cups and late aseptic revision.

Methods One review covered early migration data from radiostereometric analysis (RSA) studies, while the other focused on revision rates for aseptic loosening from long-term survival studies. Thresholds for acceptable and unacceptable migration were classified according the Swedish Hip Arthroplasty Register and the Australian National Joint Replacement Registry: < 5% revision at 10 years.

Results Following an elaborate literature search, 26 studies (involving 700 cups) were included in the RSA review and 49 studies (involving 38,013 cups) were included in the survival review. For every mm increase in 2-year proximal migration, there was a 10% increase in revision rate, which remained after correction for age, sex, diagnosis, hospital type, continent, and study quality. Consequently, proximal migration of up to 0.2 mm was considered acceptable and proximal migration of 1.0 mm or more was considered unacceptable. Cups with proximal migration of between 0.2 and 1.0 mm were considered to be at risk of having revision rates higher than 5% at 10 years.

Interpretation There was a clinically relevant association between early migration of acetabular cups and late revision due to loosening. The proposed migration thresholds can be implemented in a phased evidence-based introduction, since they allow early detection of high-risk cups while exposing a small number of patients.     

Early subsidence of shape-closed hip arthroplasty stems is associated with late revision: A systematic review and meta-analysis of 24 RSA studies and 56 survival studies

Background and purpose

Few studies have addressed the association between early migration of femoral stems and late aseptic revision in total hip arthroplasty. We performed a meta-regression analysis on 2 parallel systematic reviews and meta-analyses to determine the association between early migration and late aseptic revision of femoral stems.

Patients and methods

Of the 2 reviews, one covered early migration data obtained from radiostereometric analysis (RSA) studies and the other covered long-term aseptic revision rates obtained from survival studies with endpoint revision for aseptic loosening. Stems were stratified according to the design concept: cemented shape-closed, cemented force-closed, and uncemented. A weighted regression model was used to assess the association between early migration and late aseptic revision, and to correct for confounders. Thresholds for acceptable and unacceptable migration were determined in accordance with the national joint registries (≤ 5% revision at 10 years) and the NICE criteria (≤ 10% revision at 10 years).

Results

24 studies (731 stems) were included in the RSA review and 56 studies (20,599 stems) were included in the survival analysis review. Combining both reviews for the 3 design concepts showed that for every 0.1-mm increase in 2-year subsidence, as measured with RSA, there was a 4% increase in revision rate for the shape-closed stem designs. This association remained after correction for age, sex, diagnosis, hospital type, continent, and study quality. The threshold for acceptable migration of shape-closed designs was defined at 0.15 mm; stems subsiding less than 0.15 mm in 2 years had revision rates of less than 5% at 10 years, while stems exceeding 0.15 mm subsidence had revision rates of more than 5%.

Interpretation

There was a clinically relevant association between early subsidence of shape-closed femoral stems and late revision for aseptic loosening. This association can be used to assess the safety of shape-closed stem designs. The published research is not sufficient to allow us to make any conclusions regarding such an association for the force-closed and uncemented stems.Over 1 million total hip arthroplasties (THAs) are performed every year worldwide, and this number is expected to double within the next 2 decades (Pivec et al. 2012). The design and method of fixation of a THA determines the stability of the implant, and these are therefore crucial factors for achievement of long-term survival. However, most of the new THA designs have been introduced onto the market without demonstrating good performance (Sheth et al. 2009). This has led to several THAs having high failure rates, such as the Charnley Elite Plus (Hauptfleisch et al. 2006). To prevent future disasters with orthopedic implants, several countries have developed guidelines to guarantee patient safety, e.g. the NICE guidelines (NHS). Furthermore, it has become increasingly evident that a phased evidence-based introduction, as is common with pharmaceuticals, is necessary to regulate the introduction of new THA designs to the market (Malchau 2000, McCulloch et al. 2009, Schemitsch et al. 2010). This should include systematic assessment and early detection of aseptic loosening in small groups of patients.Although it may take as long as 10 years for aseptic loosening of implants to become manifest, it is possible to detect the loosening process as early as 1–2 years postoperatively, using radiostereometric analysis (RSA). Since RSA allows in vivo, 3D measurement of the migration of THAs with an accuracy of 0.2 mm for translations and 0.5 degrees for rotations, only a small number of patients is needed to compare a new innovative design to a gold-standard design (Grewal et al. 1992, Karrholm et al. 1994, Ryd et al. 1995, Thanner et al. 1995, Hauptfleisch et al. 2006, Nieuwenhuijse et al. 2012). Thus, only a few patients will have been exposed if that design turns out to be a poor one. RSA could therefore play an important role in phased evidence-based market introduction of new THA designs (Faro and Huiskes 1992, Bulstrode et al. 1993, Malchau 1995, 2000, Nelissen et al. 2011).Following on from our 2 earlier studies on the association between early migration and late aseptic revision of tibial components and acetabular cups, this systematic review and meta-analysis focused on the femoral stem (Pijls et al. 2012a, b). We hypothesized that early migration, as measured with RSA, is associated with late revision for aseptic loosening. We systematically reviewed the association between early migration and late revision for aseptic loosening of the femoral stem in primary THA. This could eventually lead to clinical guidelines, to be used in a phased introduction of new THA designs.     

Dextrose prolotherapy in knee osteoarthritis: A systematic review and meta-analysis

ObjectiveTo summarize the evidence for dextrose prolotherapy in knee osteoarthritis.Data sourcesThe authors searched PubMed and Embase from inception to September 2020. All publications in the English language were included without demographic limits.Study selectionRandomized clinical trials comparing the effects of any active interventions or placebo versus dextrose prolotherapy in patients with knee osteoarthritis were included.Data extractionPotential articles were screened for eligibility, and data was extracted independently. The risk of bias was assessed using the Cochrane Risk of Bias tool. Meta-analysis was performed on clinical trials with similar parameters. The Strength of Recommendation Taxonomy (SORT) was used for evaluating the strength of recommendations.Data synthesisIn total, eleven articles (n = 837 patients) met the search criteria and were included. The risk-of-bias analysis revealed two studies to be of low risk. The overall effectiveness was calculated using a meta-analysis method. Prolotherapy was no different from platelet-rich plasma on the pain subscale at the 6-month time point. Prolotherapy was inferior to platelet-rich plasma at 6 months (MD 0.45, 95% CI 0.06–0.85, p = 0.03) on the stiffness subscale. Prolotherapy was found to be safe with no major adverse effects.ConclusionProlotherapy in knee osteoarthritis confers potential benefits for pain but the studies are at high risk of bias. Based on two well-designed studies, dextrose prolotherapy may be considered in knee osteoarthritis (strength of recommendation B). This treatment is safe and may be considered in patients with limited alternative options (strength of recommendation C).     

Results of revision total knee arthroplasties using condylar prostheses. A review of fifty knees

Revisions of total knee arthroplasties for aseptic failure have provided varied results. In this review of fifty revisions in which a condylar prosthesis was used in carefully selected knees, the results were rated good or excellent in 76 per cent after an average length of follow-up of 4.8 years. At the follow-up examination, radiolucent lines were seen in 17 per cent of the knees. The complications included loosening of one or both prosthetic components in three knees (of which two were revised again); a hematoma in one knee; and a piece of loose cement, which had to be removed, in one knee. There were no deep infections. On the basis of these results, we concluded that revision total knee arthroplasty using a condylar prosthesis will have infrequent complications and will provide a satisfactory result in properly selected patients.     

Inflammatory bowel disease is associated with worse sexual function: a systematic review and meta-analysis

BackgroundSeveral studies report that sexuality is often affected by inflammatory bowel diseases (IBD). The aim of this meta-analysis was to investigate the association between IBD and sexual function.MethodsA literature search was conducted in PubMed, Web of Science, and EMBASE databases (up to September 1, 2020). Scores of sexual functions with a standard deviation and odds ratio (OR) or relative risk (RR) with a 95% CI were used to analysis the association between IBD and sexual function.ResultsEleven studies with 7,018 male IBD cases and 1,803 female IBD cases were included in the meta-analysis. In male individuals, the pooled results revealed that IBD was significantly associated with impaired erectile function and poor sexual satisfaction (RR for erectile function =1.50, 95% CI: 1.22 to 1.84, P<0.0001; standard mean difference for sexual satisfaction =−0.24, 95% CI: −0.33 to −0.15, P<0.0001). And among female individuals, IBD had impact on most sub-domains of sexual function, except pains.ConclusionsIBD is associated with worse sexual function. It has significant impact on erectile function and satisfaction for male individuals and has impact on most sub-domains of sexual function for female individuals.     

Intramedullary tibial nailing using infrapatellar and suprapatellar approaches: A systematic review and meta-analysis

IntroductionIntramedullary nailing of diaphyseal tibial fractures has become the gold standard method of fixation with high rates of union and low complication rates reported. The suprapatellar (SP) approach may have many advantages over the traditional infrapatellar (IP) approach. Controversy exists due to potential damage to the patellofemoral joint leading to persistent anterior knee pain. This systematic review and meta-analysis aims to evaluate the clinical and procedural outcomes of the SP approach in comparison to the traditional IP approach.MethodIn this PRISMA compliant systematic review and meta-analysis, five databases including MEDLINE, EMBASE, Web of Science, Cochrane Library and CINAHL were searched from inception until May 2020. Randomised controlled trials (RCTs) and comparative observational studies involving adults with tibial fractures treated with intramedullary nail fixation using either the suprapatellar or infrapatellar approach were included. Data extracted included demographics, functional knee scores, fluoroscopy exposure, insertional accuracy and adverse events. The primary outcome was validated functional knee scores. Risk of bias was calculated using the Cochrane risk of bias tool version 2 (RoB 2) and Newcastle-Ottawa Scale (NOS).ResultsIn total 16 studies were included consisting of 5 RCTs and 11 comparative observational studies. This included 1750 total operations with 810 in the SP group and 940 in the IP group. Meta-analysis was performed on the studies where appropriate data was reported. The SP approach demonstrated superior Lysholm scores (Mean Difference (MD) 5.63 [95% Confidence Interval (CI): 2.81 to 8.44]), reduced fluoroscopy times (MD -38.12 sec [95% CI: -47.96 to -28.28]) and increased entry point accuracy (Standard Mean Difference (SMD) -0.90 [95% CI: -1.22 to –0.59]). No differences in complication rates or blood loss were found.ConclusionBased on the data presented in this review, intramedullary nailing of the tibia using the SP approach demonstrates superior Lysholm knee scores, greater entry point accuracy and reduced fluoroscopy exposure with equivalent risk of developing complications when compared to the IP approach.     

Total knee arthroplasty after high tibial osteotomy. A systematic review

Background  

Previous osteotomy may compromise subsequent knee replacement, but no guidelines considering knee arthroplasty after prior osteotomy have been developed. We describe a systematic review of non-randomized studies to analyze the effect of high tibial osteotomy on total knee arthroplasty.     

Early migration of prostheses related to long-term survivorship. Comparison of tibial components in knee replacement.

We determined the cumulative survival rates, in arthroplasty of the knee, of three designs of tibial component, using a change of position on standard radiographs or revision for aseptic loosening as criteria of failure. The average migration of each of the three designs in the first postoperative year is known from roentgen stereophotogrammetric analysis reported by other authors. The ranking order of the components as judged by cumulative survival is the same as that determined by early migration. This finding supports the view that the measurement of early migration can predict late aseptic loosening and therefore that such measurements are clinically of value.     

The risk of revision in total knee arthroplasty is not affected by previous high tibial osteotomy: A 15-year follow-up of 32,476 total knee arthroplasties in the Norwegian Arthroplasty Register

Background and purpose — Previous studies have found different outcomes after revision of knee arthroplasties performed after high tibial osteotomy (HTO). We evaluated the risk of revision of total knee arthroplasty with or without previous HTO in a large registry material.Patients and methods — 31,077 primary TKAs were compared with 1,399 TKAs after HTO, using Kaplan-Meier 10-year survival percentages and adjusted Cox regression analysis.Results — The adjusted survival analyses showed similar survival in the 2 groups. The Kaplan-Meier 10-year survival was 93.8% in the primary TKA group and 92.6% in the TKA-post-HTO group. Adjusted RR was 0.97 (95% CI: 0.77–1.21; p = 0.8).Interpretation — In this registry-based study, previous high tibial osteotomy did not appear to compromise the results regarding risk of revision after total knee arthroplasty compared to primary knee arthroplasty.High tibial osteotomy (HTO) is a well-established joint preserving procedure for the treatment of medial knee osteoarthritis. The goal is to achieve unloading of the affected medial compartment of the knee to prevent or postpone the need for an artificial knee joint. This is performed by slightly overcorrecting the knee joint from varus malalignment to valgus or neutral position. Osteotomy was a standard treatment option for unicompartmental knee osteoarthritis in earlier years before knee arthroplasty was a surgical option, but osteotomy lost importance in the 1980s because of the success of knee replacement surgery (Smith et al. 2013). However, there has been an increase in osteotomies during the last 15 years, especially in younger patients in some countries (Seil et al. 2013). National arthroplasty registers have demonstrated higher risk of revision for knee arthroplasty in younger patients (under the age of 60) (NAR 2014, SKAR 2013). The 2 most commonly used methods for HTO are lateral closing wedge and medial opening wedge osteotomy. Both methods have shown improvement in knee pain and function (Naudie et al. 1999, van Raaij et al. 2008, Efe et al. 2011, W-Dahl et al. 2012). Nevertheless, some patients later require a second procedure, a total knee arthroplasty (Naudie et al. 1999), depending on the degree of osteoarthritis, their level of pain and function, and the degree of correction achieved. Although total knee arthroplasty appears to be technically more challenging after HTO in cases with severe overcorrection, bone stock loss, altered joint line (Figures 1 and ​and2),2), or patella infera, only a few studies have found inferior results compared to primary TKA (Windsor et al. 1988, Parvizi et al. 2004, Haslam et al. 2007, Farfalli et al. 2012). The aim of this study was to evaluate the risk of revision after TKA, comparing primary TKA with and without previous high tibial osteotomy using data from the Norwegian Arthroplasty Register (NAR).Open in a separate windowFigure 1.Example of extra-articular malalignment after high tibial osteotomy (HTO) with opening wedge technique. The red line on the left radiograph (a) indicates the mechanical axis lateral to the knee joint. The radiograph to the right (b) indicates the extra-articular angulation of the tibia in the osteotomy area.Open in a separate windowFigure 2.Example of intra-articular malalignment after high tibial osteotomy (WTO) with closing wedge technique. The solid red line indicates that the tibial plateau has been elevated medially and is not perpendicular to the tibial axis.     

Antibiotic cement was associated with half the risk of re-revision in 1,154 aseptic revision total knee arthroplasties

ResultsThere were 114 re-revisions (10%) with a median time to reoperation of 3.6 years (interquartile range (IQR): 2.6–5.2). The infection rate was 2.9% (34/1,154) and accounted for 30% of re-revisions (34 of 114). In adjusted models, use of antibiotic-loaded cement was associated with a 50% lower risk of all-cause re-revision surgery (hazard ratio (HR) = 0.5, 95% CI: 0.3–0.9), age with a 20% lower risk for every 10-year increase (HR = 0.8, CI: 0.7–1.0), body mass index (BMI) with a 20% lower risk for every 5-unit increase (HR = 0.8, CI: 0.7–1.0), and a surgeon’s greater cumulative experience (≥ 20 cases vs. < 20 cases) with a 3 times higher risk of re-revision (HR = 2.8, CI: 1.5–5).InterpretationRevised TKAs were at high risk of subsequent failure. The use of antibiotic-loaded cement, higher age, and higher BMI were associated with lower risk of further revision whereas a higher degree of surgeon experience was associated with higher risk.ResultsThe study cohort consisted of 1,154 aseptic revision TKAs. The mean age of the cohort was 65 (SD 10) years old, 61% were female, 32% were diabetic, 64% were white, 28% had a BMI greater than 35, and 52% had an ASA score of < 3. (2006a, Mortazavi et al. 2011, Bae et al. 2013, Luque et al. 2014). Sierra et al. (2004) reported a 40% cumulative revision risk at 20 years in 1,814 cases operated over a 30-year period. The Finnish Arthroplasty Register reported 79% survivorship of revision TKA at 10 years in 2,637 revision TKAs (Sheng et al. 2006b). In a smaller and more recent study by Luque et al. (2014), 125 aseptic revisions were reported with a minimum follow-up of 7 years and an 8-year survival of 88%. The causes of revision in our cohort parallel those presented in other studies where infection, aseptic loosening, and pain due to instability or stiffness consistently remain the leading causes of revision (Sheng et al. 2006a, Mortazavi et al. 2011, Bae et al. 2013, Luque et al. 2014).We found that the use of antibiotic cement at the time of the index revision was associated with half the risk of future all-cause revision. In a recent randomized controlled trial, the effect of vancomycin-loaded cement use in the context of 183 low-risk, aseptic revision TKAs was evaluated and a statistically significant reduction in postoperative deep infections at a minimum follow-up of 36 months was reported (none in the intervention group became infected, as compared to 7% in the control group) (Chiu and Lin 2009). However, several studies that have evaluated the association between antibiotic-loaded cement and infection after primary TKA surgery have arrived at inconsistent results. A review did not find antibiotic-loaded cement to be consistently associated with a lower risk of infection in modern, primary TKA (Jiranek et al. 2006). Also, a study by Namba et al. (2013), using the same data source as in our study, found that—paradoxically—antibiotic-loaded cement was associated with a slightly higher risk of surgical site infection after TKA. The higher risk of infection in revision TKA than in primary TKA procedures is probably the reason why we identified such a substantially lower risk of re-revision surgery in cases where antibiotic-loaded cement was used. Furthermore, the use of antibiotic bone cement in cases of subclinical or undiagnosed infections might favorably affect the results of the procedure.A second factor, the surgeon’s cumulative experience at the time of the index revision, was associated with a higher risk of re-revision surgery. As the most complex and high-risk cases are referred to more experienced surgeons, we believe that this finding is probably a proxy for case complexity, which is something we could not adjust for in our analysis. To our knowledge, the finding that higher BMI was associated with a small but statistically significantly lower risk of revision has not been reported elsewhere with respect to outcomes of revision TKA surgery, while the decrease in risk with older age has (Sheng et al. 2006b). We can only infer that activity levels may be lower in older patients or in those with a higher BMI, and that a combination of higher morbidity, higher perceived risk, and lower demand may lead to a lower revision risk associated with increasing age (Sheng et al. 2006b).After adjusting for all other risk factors, we did not find sex, race, ASA score, diabetic status, surgeon volume, hospital volume, surgeon’s TJA fellowship training, or use of hinged prosthesis at index revision to be associated with the risk of re-revision surgery.Our study had several limitations and strengths. Among the limitations, some of the data sourced for this study required voluntary surgeon participation (currently at 95%) with non-differential rates of participation across sites. There were missing data, but they were handled in the statistical analysis using multiple imputations. We do not feel that either of these limitations would affect outcomes. In addition, due to our sample size, which limited by the number of factors that could be evaluated at this time, in our analysis we were not able to evaluate the influence of surgical factors such as fixation method (i.e. cemented, uncemented, or hybrid), the extent of the index revision (i.e. 1, 2, or more components revised) and structural issues such as bone quality. Doing this might identify other risk factors for early revision. Furthermore, our decision to limit the cohort to those patients for whom the primary procedure had been captured in the registry limited us to a short follow-up period. Longer follow-up might have shown a higher percentage of patients revised for component wear or loosening. It is also likely that, as with any study of revision TKA, some patients in the cohort may have had an undiagnosed low-grade infection and that this might have skewed the overall risk of infection. Regarding surgeon experience, we note that the results can only reflect the period of data collection for the study and not lifetime experience.Among the strengths of the present study, we can include the large number of cases treated across multiple medical centers in a community-based setting, which should have provided data comparable to the experience of the majority of community surgeons. Furthermore, there was only a small possibility of data-handling bias due to the use of our integrated electronic medical record. Additionally, all of the outcomes evaluated in this study were manually adjudicated by a trained research assistant to guarantee the accuracy and integrity of the information reported, thus ensuring the high internal validity of the information reported.In summary, the most striking finding from our study of 1,154 aseptic TKA revisions is that the use of antibiotic-loaded cement was associated with half the risk of subsequent revision surgery. Infection, instability, pain, and aseptic loosening remain ongoing challenges associated with a 20% cumulative probability of failure at 5 years. Surgeons and patients alike must be cognizant of the potential for poor long-term outcomes following revision TKA.All the authors contributed to the study design and contributed substantially to collecting the data, interpreting the results, drafting the article, and to revision. PHC and MCSI conducted the statistical analysis.No competing interests declared.     

Higher cumulative revision rate of knee arthroplasties in younger patients with osteoarthritis

This study was designed to test the hypothesis that younger patients treated for osteoarthritis and similar conditions using total knee arthroplasty and unicompartmental knee arthroplasty have a lower implant survival rate when compared with older patients. Previous studies have been done on a small number of patients and only included the younger patients. In many cases patients treated for rheumatoid arthritis have been included in the studies and exceptional survival rates have been reported. The current study compared the cumulative revision rate of the components in 33,251 patients older than 60 years and 2606 patients younger than 60 years treated with total knee arthroplasty or unicompartmental knee arthroplasty for osteoarthritis or similar conditions. Cox regression was used to compare the risk for revision between the two age groups and between gender and the effect of year of operation. The results showed a higher cumulative revision rate for the group of younger patients in all statistical analyses and the risk ratio for revision was significantly lower for the group of older patients. The risk for revision decreased for both groups when considering the year of surgery. This is probably attributable to better implant components and surgical techniques.