2015 ISAKOS Biennial Congress Paper #0

Achilles Tendon Gait Dynamics After Rupture: A Three-Armed Randomized Controlled Trial Comparing An Individualized Treatment Algorithm Vs. Operative Or Non-Operative Treatment

Maria Swennergren Hansen, PT, PhD, Copenhagen DENMARK
Jesper Bencke, PhD, Copenhagen DENMARK
Morten Tange Kristensen, PT, PhD, Prof., København Nv DENMARK
Thomas Kallemose, MSc, Copenhagen DENMARK
Per Hölmich, DMSc, Prof., Copenhagen DENMARK
Kristoffer W. Barfod, MD, PhD, Virum DENMARK

1. Sports Orthopedic Research Center – Copenhagen (SORC-C), Department of Orthopedic Surgery, Copenhagen University Hospital Amager-Hvidovre, Copenhagen, DENMARK

FDA Status Not Applicable

Summary: This study presents the first evaluation of an ultrasound-based individualized treatment algorithm for patients with an Achilles tendon rupture, in a randomized controlled set up with valid functional outcomes.

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Abstract:

Introduction

Individual treatment selection has been proposed as the key to optimized treatment for patients with an Achilles tendon rupture. The purpose was to determine if walking pattern, Achilles tendon elongation and patient reported outcome measure differ between patients having their treatment selected using the individualized treatment algorithm Copenhagen Achilles Rupture Treatment Algorithm (CARTA) and patients treated as usual (operative or non-operative by default).

Materials And Methods

The trial was performed as a three-armed randomized controlled trial with the patients randomized in a 1:1:1 order to one of three parallel groups; 1) Intervention group: Participants treated according to the individualized ultrasound based treatment algorithm CARTA, 2) Control group: Participants treated non-operatively, 3) Control group: Participants treated operatively.
The present study evaluates the newly developed CARTA, an individualized treatment algorithm based on an ultrasonographic examination. Firstly, the degree of overlap at the site of rupture was examined by looking at the cross-sectional area. If the investigator could identify a transverse picture with less than 25% fibers of the cross-sectional area, the rupture was evaluated not to overlap. If more than 25%, the tendon was evaluated to overlap. If no overlap was present operation was indicated. Secondly, the tendon elongation was measured by using the Copenhagen Achilles Length Measure. Both legs were examined and the difference between the sides was calculated as the elongation and was given in percent of the length of the non-injured tendon. Patients with up to 7% elongation were treated non-operatively and patients with 7% or more were treated operatively.
Patients aged 18-65 years were eligible for inclusion. The primary outcome was peak ankle plantarflexor power during push when walking at 12 months measured in a 3D gait laboratory. Secondary outcomes were peak ankle plantarflexor moment, peak ankle dorsiflexion during stance phase, tendon elongation and Achilles tendon Total Rupture Score (ATRS). Analysis was conducted as intention-to-treat.

Results

156 patients were assessed for eligibility. 21 were allocated to the intervention group and 20 and 19 to the control groups. The results indicated no statistically significant differences between the intervention group and the control groups at 6- and 12-months follow-up for the primary or any of the secondary outcomes.

Conclusion

Individualized treatment selection for operative vs non-operative treatment based on CARTA did not seem to result in less affected gait dynamics or less tendon elongation than usual care.