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Rehabilitation strategy after non-surgical treatment of Achilles tendon rupture : UKSTAR, a multicentre RCT
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UKSTAR Trial Collaborators (Including: Costa, Matthew L., Achten, Juul, Marian, Ioana R., Dutton, Susan J., Lamb, Sarah E., Ollivere, Benjamin, Maredza, Mandy, Petrou, Stavros and Kearney, Rebecca S.). (2020) Rehabilitation strategy after non-surgical treatment of Achilles tendon rupture : UKSTAR, a multicentre RCT. Health Technology Assessment, 24 (8). doi:10.3310/hta24080 ISSN 1366-5278.
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WRAP-rehabilitation-strategy-non-surgical-achilles-rupture-RCT-Costa-2020.pdf - Accepted Version - Requires a PDF viewer. Download (2900Kb) | Preview |
Official URL: https://doi.org/10.3310/hta24080
Abstract
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.
| Item Type: | Journal Article | ||||||||||||
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| Subjects: | R Medicine > RD Surgery | ||||||||||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Achilles tendon -- Wounds and injuries , Achilles tendon -- Wounds and injuries -- Treatment, Ankle -- Fractures , Ankle -- Fractures -- Treament, Tendons -- Wounds and injuries -- Treatment | ||||||||||||
| Journal or Publication Title: | Health Technology Assessment | ||||||||||||
| Publisher: | NIHR Health Technology Assessment programme | ||||||||||||
| ISSN: | 1366-5278 | ||||||||||||
| Official Date: | February 2020 | ||||||||||||
| Dates: |
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| Volume: | 24 | ||||||||||||
| Number: | 8 | ||||||||||||
| DOI: | 10.3310/hta24080 | ||||||||||||
| Status: | Peer Reviewed | ||||||||||||
| Publication Status: | Published | ||||||||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||||||||
| Date of first compliant deposit: | 4 February 2020 | ||||||||||||
| Date of first compliant Open Access: | 18 February 2021 | ||||||||||||
| RIOXX Funder/Project Grant: |
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