Aims

To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures.

Introduction. Surgeons, commissioners and patients are increasingly seeking more in depth details on outcomes of total ankle replacement (TAR). We set out to perform a detailed and up to date meta-analysis of the outcomes of TAR, with a focus on PROMS. Methods. We searched MEDLINE, Cochrane, EMBASE, CINAHL and the Science Citation Index databases using the terms “total”; “ankle”; “arthroplasty” or “replacement” to April 2012. We included all languages; series with greater than 20 TAR; minimum 2 years follow-up. We excluded papers on revisions; prostheses no longer marketed; and kin studies. We worked with the Cochrane Collaboration to adopt their methodology including the creation of a risk profile assessing all forms of bias. Results. Of 1841 papers identified, 51 remained for analysis, with a pool of 6719 patients. The mean patient age was 59.3(17–95) and mean BMI was 28.8(19.4–44). 53% of patients were male. The most common indication was posttraumatic osteoarthritis. The majority of the studies were level IV and more than half the studies had several forms of bias. Intraoperative complication rate was 9%, with medial malleolar fracture (4.4%) being the most common. The pooled mean pre-op VAS was 7.6 which improved to 1.5 at 4–5 years. The mean pre-op AOFAS was 39.7, improving to 79.9 for up-to 10 years. Range-of-motion increased after TAR from 22.8° preoperatively to 33.6° postoperatively. Radiographic abnormalities were found in 22% of cases with a mean follow up of 53 months, of which 7.9% were re-operated upon. Gait velocity, cadence, stride length and power all improve following TAR. Survival at 8–10 years was 89.4%, with a cumulative failure rate of 1.9%. Conclusion. This is the most comprehensive meta-analysis carried out on TAR to date. TAR provides patients with an increased range of motion and improvement postoperative PROMS maintained up to 10 years

We performed a systematic review and meta-analysis of modern total ankle replacements (TARs) to determine the survivorship, outcome, complications, radiological findings and range of movement, in patients with end-stage osteoarthritis (OA) of the ankle who undergo this procedure. We used the methodology of the Cochrane Collaboration, which uses risk of bias profiling to assess the quality of papers in favour of a domain-based approach. Continuous outcome scores were pooled across studies using the generic inverse variance method and the random-effects model was used to incorporate clinical and methodological heterogeneity. We included 58 papers (7942 TARs) with an interobserver reliability (Kappa) for selection, performance, attrition, detection and reporting bias of between 0.83 and 0.98. The overall survivorship was 89% at ten years with an annual failure rate of 1.2% (95% confidence interval (CI) 0.7 to 1.6). The mean American Orthopaedic Foot and Ankle Society score changed from 40 (95% CI 36 to 43) pre-operatively to 80 (95% CI 76 to 84) at a mean follow-up of 8.2 years (7 to 10) (p < 0.01). Radiolucencies were identified in up to 23% of TARs after a mean of 4.4 years (2.3 to 9.6). The mean total range of movement improved from 23° (95% CI 19 to 26) to 34° (95% CI 26 to 41) (p = 0.01).

Our study demonstrates that TAR has a positive impact on patients’ lives, with benefits lasting ten years, as judged by improvement in pain and function, as well as improved gait and increased range of movement. However, the quality of evidence is weak and fraught with biases and high quality randomised controlled trials are required to compare TAR with other forms of treatment such as fusion.

Cite this article: Bone Joint J 2013;95-B:1500–7.