The Exeter femoral stem continues to migrate during its first decade after implantation: 10–12 years of follow-up with radiostereometric analysis (RSA)

Optimising joint reconstruction management in arthritis and bone tumour patient

Effect of surgical experience and spine subspecialty on the reliability of the {AO} Spine Upper Cervical Injury Classification System

OBJECTIVE The objective of this paper was to determine the interobserver reliability and intraobserver reproducibility of the AO Spine Upper Cervical Injury Classification System based on surgeon experience (< 5 years, 5–10 years, 10–20 years, and > 20 years) and surgical subspecialty (orthopedic spine surgery, neurosurgery, and "other" surgery). METHODS A total of 11,601 assessments of upper cervical spine injuries were evaluated based on the AO Spine Upper Cervical Injury Classification System. Reliability and reproducibility scores were obtained twice, with a 3-week time interval. Descriptive statistics were utilized to examine the percentage of accurately classified injuries, and Pearson’s chi-square or Fisher’s exact test was used to screen for potentially relevant differences between study participants. Kappa coefficients (κ) determined the interobserver reliability and intraobserver reproducibility. RESULTS The intraobserver reproducibility was substantial for surgeon experience level (< 5 years: 0.74 vs 5–10 years: 0.69 vs 10–20 years: 0.69 vs > 20 years: 0.70) and surgical subspecialty (orthopedic spine: 0.71 vs neurosurgery: 0.69 vs other: 0.68). Furthermore, the interobserver reliability was substantial for all surgical experience groups on assessment 1 (< 5 years: 0.67 vs 5–10 years: 0.62 vs 10–20 years: 0.61 vs > 20 years: 0.62), and only surgeons with > 20 years of experience did not have substantial reliability on assessment 2 (< 5 years: 0.62 vs 5–10 years: 0.61 vs 10–20 years: 0.61 vs > 20 years: 0.59). Orthopedic spine surgeons and neurosurgeons had substantial intraobserver reproducibility on both assessment 1 (0.64 vs 0.63) and assessment 2 (0.62 vs 0.63), while other surgeons had moderate reliability on assessment 1 (0.43) and fair reliability on assessment 2 (0.36). CONCLUSIONS The international reliability and reproducibility scores for the AO Spine Upper Cervical Injury Classification System demonstrated substantial intraobserver reproducibility and interobserver reliability regardless of surgical experience and spine subspecialty. These results support the global application of this classification system

Appraisal of evidence base for introduction of new implants in hip and knee replacement: a systematic review of five widely used device technologies

Objective To determine the evidence of effectiveness and safety for introduction of five recent and ostensibly high value implantable devices in major joint replacement to illustrate the need for change and inform guidance on evidence based introduction of new implants into healthcare. Design Systematic review of clinical trials, comparative observational studies, and registries for comparative effectiveness and safety of five implantable device innovations. Data sources PubMed (Medline), Embase, Web of Science, Cochrane, CINAHL, reference lists of articles, annual reports of major registries, summaries of safety and effectiveness for pre-market application and mandated post-market studies at the US Food and Drug Administration. Study selection The five selected innovations comprised three in total hip replacement (ceramic-on-ceramic bearings, modular femoral necks, and uncemented monoblock cups) and two in total knee replacement (high flexion knee replacement and gender specific knee replacement). All clinical studies of primary total hip or knee replacement for symptomatic osteoarthritis in adults that compared at least one of the clinical outcomes of interest (patient centred outcomes or complications, or both) in the new implant group and control implant group were considered. Data searching, abstraction, and analysis were independently performed and confirmed by at least two authors. Quantitative data syntheses were performed when feasible. Results After assessment of 10 557 search hits, 118 studies (94 unique study cohorts) met the inclusion criteria and reported data related to 15 384 implants in 13 164 patients. Comparative evidence per device innovation varied from four low to moderate quality retrospective studies (modular femoral necks) to 56 studies of varying quality including seven high quality (randomised) studies (high flexion knee replacement). None of the five device innovations was found to improve functional or patient reported outcomes. National registries reported two to 12 year follow-up for revision occurrence related to more than 200 000 of these implants. Reported comparative data with well established alternative devices (over 1 200 000 implants) did not show improved device survival. Moreover, we found higher revision occurrence associated with modular femoral necks (hazard ratio 1.9) and ceramic-on-ceramic bearings (hazard ratio 1.0-1.6) in hip replacement and with high flexion knee implants (hazard ratio 1.0-1.8). Conclusion We did not find convincing high quality evidence supporting the use of five substantial, well known, and already implemented device innovations in orthopaedics. Moreover, existing devices may be safer to use in total hip or knee replacement. Improved regulation and professional society oversight are necessary to prevent patients from being further exposed to these and future innovations introduced without proper evidence of improved clinical efficacy and safety

New Vertebral Fractures after Percutaneous Vertebroplasty for Painful Osteoporotic Vertebral Compression Fractures: A Clustered Analysis and the Relevance of Intradiskal Cement Leakage

Optimising joint reconstruction management in arthritis and bone tumour patient

Early subsidence of shape-closed hip arthroplasty stems is associated with late revision

<div><p><b>Background and purpose —</b> 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.</p><p><b>Patients and methods —</b> 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).</p><p><b>Results —</b> 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%.</p><p><b>Interpretation —</b> 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.</p></div

5-year clinical and radiostereometric analysis (RSA) follow-up of 39 CUT femoral neck total hip prostheses in young osteoarthritis patients

BACKGROUND: As the number of young patients receiving total hip arthroplasty increases, bone-saving implantations facilitating possible future revision, such as the CUT femoral neck prosthesis, are gaining importance. There have been few medium-term results reported for this prosthesis, however, and its migration pattern has not been analyzed. PATIENTS AND METHODS: 39 consecutive CUT femoral neck prostheses were implanted in 32 patients, mean age 37 (17–58) years, with symptomatic osteoarthritis and either less than 55 years of age or with an anatomic anomaly preventing implantation of a diaphyseal stem (n = 1). Patients were followed prospectively using routine clinical examination and radiostereometric analysis (RSA) at 6, 12, 26, and 52 weeks postoperatively and annually thereafter. This study evaluated the 5-year follow-up results. RESULTS: The mean Harris hip score increased from 26 (3–51) points preoperatively to 84 (66–98), 86 (55–98), and 87 (47–98) points at 3, 12, and 60 months. 3 stems were revised: 1 after luxation following excessive subsidence due to an undersized component and 2 due to persistent strong thigh pain. 5-year survival was 95% (95% CI: 87–100). Initial migration varied widely in magnitude; median total tip migration was 0.42 mm (0.09–9.4) at 6 weeks, 0.92 mm (0.18–5.9) at 1 year, and 1.10 mm (0.13–6.4) at 5 years. Even after high initial migration, stabilization was achieved in 31 of the 35 RSA-evaluable implants. 3 prostheses showed progressive continuous migration throughout the entire follow-up period, and were considered to be loose, suggesting reduced long-term survival. INTERPRETATION: Currently, we cannot recommend the CUT femoral neck prosthesis as a routine treatment option in (young) patients requiring THA. The CUT prosthesis may not reach the 90% survival benchmark at 10 years, and the prosthesis is difficult to implant. If initial stabilization is achieved, however, aseptic loosening is unlikely. A good clinical outcome was seen in the surviving prostheses. We will continue to follow this patient group

RSA prediction of high failure rate for the uncoated Interax TKA confirmed by meta-analysis

BACKGROUND AND PURPOSE: In a previous radiostereometric (RSA) trial the uncoated, uncemented, Interax tibial components showed excessive migration within 2 years compared to HA-coated and cemented tibial components. It was predicted that this type of fixation would have a high failure rate. The purpose of this systematic review and meta-analysis was to investigate whether this RSA prediction was correct. MATERIALS AND METHODS: We performed a systematic review and meta-analysis to determine the revision rate for aseptic loosening of the uncoated and cemented Interax tibial components. RESULTS: 3 studies were included, involving 349 Interax total knee arthroplasties (TKAs) for the comparison of uncoated and cemented fixation. There were 30 revisions: 27 uncoated and 3 cemented components. There was a 3-times higher revision rate for the uncoated Interax components than that for cemented Interax components (OR = 3; 95% CI: 1.4–7.2). INTERPRETATION: This meta-analysis confirms the prediction of a previous RSA trial. The uncoated Interax components showed the highest migration and turned out to have the highest revision rate for aseptic loosening. RSA appears to enable efficient detection of an inferior design as early as 2 years postoperatively in a small group 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