Background: Achilles tendon rupture affects > 11,000 people each year in the UK, leading to prolonged periods away from work, sports and social activities. Traditionally, the ruptured tendon is held still in a plaster cast for ≥ 8 weeks. Functional bracing is an alternative treatment that allows patients to mobilise earlier, but there is little evidence about how bracing affects patients' recovery.
Objectives: To measure the Achilles Tendon Rupture Score, quality of life, complications and resource use of patients receiving non-operative treatment for an Achilles tendon rupture treated with plaster cast compared with those treated with functional bracing.
Design: This was a multicentre, randomised, pragmatic, two-group superiority trial.
Setting: The setting was 39 NHS hospitals.
Participants: A total of 540 adult patients treated non-operatively for Achilles tendon rupture were randomised from July 2016 to May 2018. Exclusion criteria included presenting after 14 days, having had previous rupture and being unable to complete questionnaires.
Interventions: A total of 266 participants had a plaster cast applied, with their toes initially pointing to the floor. The cast was changed over 8 weeks to bring the foot into a walking position. A total of 274 patients had a functional brace that facilitated immediate weight-bearing. The foot position was adjusted within the brace over the same 8-week period.
Main outcome measures: Achilles Tendon Rupture Score is patient reported and assesses symptoms and physical activity related to the Achilles tendon (score 0-100, with 100 being the best possible outcome). The secondary outcomes were quality of life, complications and resource use at 8 weeks and at 3, 6 and 9 months.
Results: Participants had a mean age of 48.7 years, were predominantly male (79%) and had ruptured their tendon during sports (70%). Over 93% of participants completed follow-up. There was no statistically significant difference in Achilles Tendon Rupture Score at 9 months post injury (-1.38, 95% confidence interval -4.9 to 2.1). There was a statistically significant difference in Achilles Tendon Rupture Score at 8 weeks post injury in favour of the functional brace group (5.53, 95% confidence interval 2.0 to 9.1), but not at 3 or 6 months post injury. Quality of life showed the same pattern, with a statistically significant difference at 8 weeks post injury but not at later time points. Complication profiles were similar in both groups. Re-rupture of the tendon occurred 17 times in the plaster cast group and 13 times in the functional brace group. There was no difference in resource use.
Conclusions: This trial provides strong evidence that early weight-bearing in a functional brace provides similar outcomes to traditional plaster casting and is safe for patients receiving non-operative treatment of Achilles tendon rupture. The probability that functional bracing is cost-effective exceeds 95% for the base-case imputed analysis, assuming a cost-effectiveness threshold of £20,000 per quality-adjusted life-year. On average, functional brace is associated with lower costs (-£103, 95% confidence interval -£290 to £84) and more quality-adjusted life-years (0.015, 95% confidence interval -0.0013 to 0.030) than plaster cast.
Limitations: Some patients declined to participate in the trial, but only a small proportion of these declined because they had a preference for one treatment or another. Overall, 58% of eligible patients agreed to participate, so the participants are broadly representative of the population under investigation.
Future work: Although the UK Study of Tendo Achilles Rehabilitation provides guidance with regard to early management, rehabilitation following Achilles tendon rupture is prolonged and further research is required to define the optimal mode of rehabilitation after the initial cast/brace has been removed.
Trial registration: Current Controlled Trials ISRCTN62639639.
Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 8. See the NIHR Journals Library website for further project information.
Keywords: ACHILLES; ANKLE; REHABILITATION; RUPTURE; TENDON.
Achilles tendon rupture affects > 11,000 people each year in the UK, leading to prolonged periods away from work, sports and social activities. Traditionally, after a ruptured tendon, the foot and ankle are held still in a plaster cast for ≥ 8 weeks. Functional bracing is an alternative treatment that allows patients to mobilise earlier, but there is little evidence about how it affects later recovery. This study aimed to compare traditional plaster casting with functional bracing for adult patients with Achilles tendon rupture. The participants reported their own recovery using the Achilles Tendon Rupture Score, which consists of 10 questions about symptoms and physical activity (in which a score of 100 is the best possible outcome). We also recorded quality of life, complications, including re-rupture of the tendon, and costs from both the NHS and the patients’ perspective. A total of 540 patients, treated at 39 hospitals, agreed to take part and were assigned by chance to either plaster cast or functional brace. Patients reported their recovery at 8 weeks and at 3, 6 and 9 months.
What did the trial find?: Patients recovered steadily after their injury but were still not back to normal at 9 months. The average Achilles Tendon Rupture Score rose from 38 out of 100 at 8 weeks to 73 out of 100 at 9 months. Patents who had the functional brace reported that their recovery was a little better at 8 weeks than did the patients having the plaster cast, but there was no evidence of a difference after that. There were 17 cases of re-rupture of the Achilles tendon in the plaster cast group and 13 cases in the functional brace group. There was no evidence of a difference in costs. In conclusion, this study provides strong evidence that early weight-bearing in a functional brace provides similar outcomes to traditional plaster casting and is safe for patients having treatment for Achilles tendon rupture.