Background Early controlled motion (ECM) of the ankle is widely used in the non-operative treatment of acute Achilles tendon rupture, although its safety and efficacy have not been investigated properly in a randomised set-up.
Purpose/Aim of the study To investigate if ECM of the ankle was superior to immobilisation in the treatment of acute Achilles tendon rupture.
Materials and methods This was an assessor-blinded, randomised controlled trial with patients allocated in a 1:1 ratio to one of two parallel groups. Patients aged 18–70 years were eligible for inclusion. The ECM group performed movements of the ankle five times a day from week 3 to week 8 after rupture. The control group was immobilised for 8 weeks. The primary outcome was the Achilles tendon Total Rupture Score (ATRS) evaluated at 1-year postinjury. The secondary outcomes were heel-rise work test (HRW), Achilles tendon elongation and rate of rerupture. Analysis was conducted as intention-to-treat using inverse probability weighting.
Findings/Results 189 patients were assessed for eligibility and 130 were included from February 2014 to December 2016. There were 64 patients in the ECM group and 58 in the immobilisation group. There were no statistically significant differences (p>0.3) between the ECM and the immobilisation groups at 1 year: mean (SD) ATRS was 74 (18) and 75 (18), respectively. HRW was 60% (21) and 60% (21) of the uninjured limb, and elongation was 18 mm (13) and 16 mm (11), respectively. Correspondingly, there were six and seven reruptures.
Conclusions ECM revealed no benefit compared with immobilisation in any of the investigated outcomes.
Trial registration number NCT02015364
- achilles tendon
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Contributors All authors have contributed to planning, conduct and reporting of the work described in the article. KWB planned and conducted the study, analysed the results, and wrote the paper. He is responsible for the overall content as guarantor. MSH was clinically responsible for the inclusion, randomisation and treatment of the patients. She contributed to the interpretation of the results and review of the paper. PH, MTK and AT contributed to study design, analysis plan, interpretation of the results and review of the paper.
Funding This study was funded by Gigtforeningen (€11 000) and DJO Nordic (€44 000).
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval Ethical approval was obtained on 18 December 2013 from the Ethical Review Board of the Capital Region of Denmark (identifier: H-4-2013-176).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon request.
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