• Kristoffer Weisskirchner Barfod, Maria Swennergren Hansen, Per Holmich, Anders Troelsen, and Morten Tange Kristensen.
• Department of Orthopedic Surgery, Clinical Orthopedic Research Hvidovre, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, Hvidovre, 2650, Denmark. kbarfod@dadlnet.dk.
• Trials. 2016 Nov 29; 17 (1): 564.

BackgroundEarly controlled ankle motion is widely used in the non-operative treatment of acute Achilles tendon rupture, though its safety and efficacy have never been investigated in a randomized setup. The objectives of this study are to investigate if early controlled motion of the ankle affects functional and patient-reported outcomes.Methods/DesignThe study is performed as a blinded, randomized, controlled trial with patients allocated in a 1:1 ratio to one of two parallel groups. Patients aged from 18 to 70 years are eligible for inclusion. The intervention group performs early controlled motion of the ankle in weeks 3-8 after rupture. The control group is immobilized. In total, 130 patients will be included from one big orthopedic center over a period of 2½ years. The primary outcome is the patient-reported Achilles tendon Total Rupture Score evaluated at 12 months post-injury. Secondary outcome measures are the heel-rise work test, Achilles tendon elongation, and the rate of re-rupture. The primary analysis will be conducted as intention-to-treat analyses.DiscussionThis trial is the first to investigate the safety and efficacy of early controlled motion in the treatment of acute Achilles tendon rupture in a randomized setup. The study uses the patient-reported outcome measure, the Achilles tendon Total Rupture Score, as the primary endpoint, as it is believed to be the best surrogate measure for the tendon's actual capability to function in everyday life.Trial RegistrationClinicalTrials.gov: NCT02015364 . Registered on 13 December 2013.

34 keywords...

hide…