Revision rates after total ankle arthroplasty in sample-based clinical studies and national registries.
ABSTRACT The aim of this study was to evaluate the outcome of specific implants in total ankle arthroplasty as reported in clinical studies and determined by national registries. MATERIALS and
A structured literature review was conducted regarding sample-based clinical studies and national registry data. To allow for comparative analyses, registry data had to be available for the implants included. These were STAR Ankle, Büchel-Pappas, Hintegra, Mobility, Agility, and Ramses Total Ankle Arthroplasty. The revision rate was used as the main outcome parameter.
On average, the revision rates published in sample-based clinical studies were about half the value found in registries. Implant developers represent a share of almost 50% of the published content and are therefore over-represented in scientific publications. The inventors of STAR Ankle and BP total ankle implants published data which was statistically significantly superior to the outcome achieved in average patients as documented in registries. Irrespective of the implant, the average revision rate to be expected according to the registry data available is 21.8% after 5 years, and 43.5% after 10 years.
The average revision rate published in peer-reviewed scientific articles was significantly lower than the outcome achieved according to national arthroplasty registry data, which reflect actual average patient care in the respective countries. Publications by some research groups, particularly by implant inventors, show a deviation from the outcome published by other users and those shown in registry data.
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ABSTRACT: Surgical treatments for end-stage ankle arthritis include total ankle replacement and ankle arthrodesis. Although arthrodesis is a reliable procedure, ankle replacement is often preferred by patients. This prospective study evaluated intermediate-term outcomes of ankle replacement and arthrodesis in a large cohort at multiple centers, with variability in ankle arthritis type, prosthesis type, surgeon, and surgical technique. We hypothesized that patient-reported clinical outcomes would be similar for both procedures. Patients in the Canadian Orthopaedic Foot and Ankle Society (COFAS) Prospective Ankle Reconstruction Database were treated with total ankle replacement (involving Agility, STAR, Mobility, or HINTEGRA prostheses) or ankle arthrodesis by six subspecialty-trained orthopaedic surgeons at four centers between 2001 and 2007. Data collection included demographics, comorbidities, and the Ankle Osteoarthritis Scale (AOS) and Short Form-36 (SF-36) scores. The preoperative and latest follow-up scores for patients with at least four years of follow-up were analyzed. Sensitivity analyses excluded ankles that had undergone revision. A linear mixed-effects regression model compared scores between the groups, adjusting for age, sex, side, smoking status, body mass index, inflammatory arthritis diagnosis, baseline score, and surgeon. Of the 388 ankles (281 in the ankle replacement group and 107 in the arthrodesis group), 321 (83%; 232 ankle replacements and eighty-nine arthrodeses) were reviewed at a mean follow-up of 5.5 ± 1.2 years. Patients treated with arthrodesis were younger, more likely to be diabetic, less likely to have inflammatory arthritis, and more likely to be smokers. Seven (7%) of the arthrodeses and forty-eight (17%) of the ankle replacements underwent revision. The major complications rate was 7% for arthrodesis and 19% for ankle replacement. The AOS total, pain, and disability scores and SF-36 physical component summary score improved between the preoperative and final follow-up time points in both groups. The mean AOS total score improved from 53.4 points preoperatively to 33.6 points at the time of follow-up in the arthrodesis group and from 51.9 to 26.4 points in the ankle replacement group. Differences in AOS and SF-36 scores between the arthrodesis and ankle replacement groups at follow-up were minimal after adjustment for baseline characteristics and surgeon. Intermediate-term clinical outcomes of total ankle replacement and ankle arthrodesis were comparable in a diverse cohort in which treatment was tailored to patient presentation; rates of reoperation and major complications were higher after ankle replacement. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence. PEER REVIEW This article was reviewed by the Editor-in-Chief and one Deputy Editor, and it underwent blinded review by two or more outside experts. It was also reviewed by an expert in methodology and statistics. The Deputy Editor reviewed each revision of the article, and it underwent a final review by the Editor-in-Chief prior to publication. Final corrections and clarifications occurred during one or more exchanges between the author(s) and copyeditors.The Journal of Bone and Joint Surgery 01/2014; 96(2):135-42. · 4.31 Impact Factor
- The Journal of arthroplasty 01/2014; · 2.37 Impact Factor
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ABSTRACT: Tibiotalocalcaneal arthrodesis with an intramedullary hindfoot nail is an established procedure for fusion of the ankle and subtalar joints. In cases involving ankle bone loss, such as in failed total ankle replacement, it can be difficult to salvage with sufficient bone restoration stability and a physiologic leg length and avoiding below the knee amputation. In addition to the alternatives of using a structural allograft or metal bone substitution, we describe the use of autologous ipsilateral circular pillar fibula augmentation in tibiotalocalcaneal retrograde nail arthrodesis combined with a ventral (anterior) plate in a prospective series of 6 consecutive cases with a mean follow-up duration of 26 ± 9.95 (range 12 to 34) months. The 6 patients (3 female and 3 male), with a mean age of 55 ± 13.89 (range 38 to 73) years were treated with revision surgery of the ankle (1 after talectomy, 5 [83.33%] after failed ankle replacement). The visual analog scale for pain and the American Orthopaedic Foot and Ankle Society hindfoot score were used to assess functional outcome, and radiographs and computed tomography scans were used to determine the presence of fusion. All patients improved clinically from pre- to postoperatively in regard to the mean pain visual analog scale score (from 7.5 to 2.0) and American Orthopaedic Foot and Ankle Society hindfoot score (from 29 to 65 points, of an 86-point maximum for fused joints). Radiologically, no loss in the reduction or misalignment of the hindfoot was detected, and all cases fused solid. One patient (16.67%) required hardware removal. The fixation construct provided good clinical and radiologic outcomes, and we recommend it as an alternative to structural allografts or metallic bone grafts for revision ankle surgery with severe bone loss.The Journal of foot and ankle surgery: official publication of the American College of Foot and Ankle Surgeons 04/2014;