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1.  Early proximal migration of cups is associated with late revision in THA 
Acta Orthopaedica  2012;83(6):583-591.
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.
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.
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.
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.
PMCID: PMC3555453  PMID: 23126575
2.  5-year clinical and radiostereometric analysis (RSA) follow-up of 39 CUT femoral neck total hip prostheses in young osteoarthritis patients 
Acta Orthopaedica  2012;83(4):334-341.
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.
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.
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.
PMCID: PMC3427622  PMID: 22880707
3.  The Exeter femoral stem continues to migrate during its first decade after implantation 
Acta Orthopaedica  2012;83(2):129-134.
Due to its collarless, double-tapered polished design, the Exeter femoral stem is known to migrate distally in the first 5 years after implantation. However, its long-term migration pattern has not been investigated.
Patients and methods
39 consecutive patients (41 total hip arthroplasties) received a cemented Exeter stem and had prospective clinical and RSA follow-up. Patients were evaluated postoperatively at 6, 12, 26, and 52 weeks, and annually thereafter. Short-term results have been reported. In this study, the mean length of follow-up was 9.4 years (SD 3.2 years). No patients were lost to follow-up. 15 patients died during follow-up.
No stems were revised. In 4 stems, fractures of the cement mantle were noted within the first 3 postoperative years. In 3 stems, this resulted in a complete circumferential cement mantle discontinuity. For the 37 well-performing stems, continuous but small migration was measured between 2 and 12 years of follow-up. Continued subsidence of 0.08 mm/year (95% CI: 0.05–0.12, p < 0.001) was seen in combination with continued rotation in retroversion of 0.07°/year (95% CI: 0.02–0.12, p = 0.01). At 10 years of follow-up, mean subsidence was 2.1 (SD 1.2) mm and mean retroversion was 1.8° (SD 2.0). Two-thirds of this occurred during the first 2 postoperative years. In the 3 stems with a complete circumferential cement fracture, a sudden and disproportionately high increase in subsidence was measured in the time period of occurrence.
The Exeter femoral stem continues to migrate during the first decade after implantation. Absolute stability is not required for good long-term survival if this is compatible with the design of the implant.
PMCID: PMC3339525  PMID: 22401676
4.  RSA prediction of high failure rate for the uncoated Interax TKA confirmed by meta-analysis 
Acta Orthopaedica  2012;83(2):142-147.
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.
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).
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.
PMCID: PMC3339527  PMID: 22530953
5.  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.
PMCID: PMC4159610  PMID: 25208953

Results 1-5 (5)