A Prospective Randomized Comparison of Functional Bracing Versus Rigid Immobilization After Modified Percutaneous Achilles Tendon Repair Under Local Anesthesia

Rationale & background information There is ongoing controversy over the optimal treatment and rehabilitation strategy of an acute Achilles tendon rupture. Percutaneous suturing seems to bridge the gap between open surgical and conservative treatment, but still raises scepticism due to concerns like strength of the repair, approximation of torn ends, re-rupture rate, sural nerve injuries, early functional rehabilitation and thus final outcome. The highest general complication rate (15.6%) is reported in patients treated with percutaneous repair and early mobilization. The purpose of the study is to analyze the results of two ways of postoperative regimen after treatment with the modified and biomechanically significantly stronger percutaneous repair under local anesthesia.

Study goals and objectives The goals of the study are to compare the results of two ways of postoperative regimen after treatment with the modified and biomechanically significantly stronger percutaneous repair under local anesthesia . Objectives are to find whether the modified repair is strong enough to be used with functional treatment that enables more comfort and earlier rehabilitation to the patients with comparable end (functional) results and no more complications (particularly re-ruptures).

Study design

This will be a 4-year prospective observational study, with a 3-year follow up of all the consecutive patients who will meet the inclusion criteria:

1) patients 18 years of age or older; 2) a rupture that occurred no more than 7 days before the operating procedure; 3) closed, complete ATR; 4) a rupture that occurred in the tendinous portion (2-8 cm proximal to the insertion); 5) no previous operative procedures or history of partial or complete rupture of the involved tendon; 6) no previous local, oral or parenteral therapy that might have weakened the tendon (for instance local infiltration of anesthetics or steroids in the AT region, oral or parenteral immunosuppressive therapy in patients with transplanted organs or immune diseases etc.). The diagnosis must be confirmed clinically with palpable gap in the tendon, positive Thompson's test and inability of the patients to raise on their toes or heel. The diagnosis will be routinely checked by ultrasonography and in any case of doubt with MRI.