Acute Achilles tendon rupture: minimally invasive surgery versus non operative treatment, with immediate full weight bearing. Design of a randomized controlled trial

BACKGROUND: We present the design of an open randomized multi-centre study on surgical versus conservative treatment of acute Achilles tendon ruptures. The study is designed to evaluate the effectiveness of conservative treatment in reducing complications when treating acute Achilles tendon rupture. METHODS/DESIGN: At least 72 patients with acute Achilles tendon rupture will be randomized to minimally invasive surgical repair followed by functional rehabilitation using tape bandage or conservative treatment followed by functional rehabilitation with use of a functional bracing system. Both treatment arms use a 7 weeks post-rupture rehabilitation protocol. Four hospitals in the Netherlands will participate. Primary end-point will be reduction in complications other than re-rupture. Secondary end-point will be re-rupturing, time off work, sporting activity post rupture, functional outcome by Leppilahti score and patient satisfaction. Patient follow-up will be 12 month. DISCUSSION: By making this design study we wish to contribute to more profound research on AT rupture treatment and prevent publication bias for this open-labelled randomized trial. TRIAL REGISTRATION: ISRCTN50141196