Individualized Treatment of Acute Achilles Tendon Rupture

NACompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

October 2, 2018

Primary Completion Date

September 24, 2024

Study Completion Date

September 24, 2024

Conditions
Achilles Tendon Rupture
Interventions
PROCEDURE

Individualized treatment of Acute Achilles tendon rupture.

The most proximal border of the calcaneus and the most distal point of the musculotendinous junction of the Achilles tendon and the medial gastrocnemius muscle is identified and marked on the skin. These two points on the un-injured leg defines the original length of the total Achilles tendon and consist of the free tendon and the fascia \[1\]. The difference in length between the injure and the un-injured leg determines elongation for the ruptured Achilles tendon. The relative elongation of the ruptured tendon together with overlap of the tendon ends on the cross-sectional area determines the treatment for the patients receiving individualized treatment: 1) patients with 0-6% elongation of the tendon and a minimum of 25% tendon are treated non-operatively 2) patients with 7% elongation or more or less than 25% tendon overlap are treated operatively. The cut-off at 7% elongation is determined for 75% sensitivity and 65% specificity of elongation.

PROCEDURE

Non-operative treatment

Circulated cast below the knee in maximal, unforced plantar flexion over the ankel.

PROCEDURE

Operative treatment

Open surgery with suture of the ruptured achilles tendon prior to circulated cast below the knee in maximal, unforced plantar flexion over the ankel.

Trial Locations (4)

DK-2650

Copenhagen University Hospital, Hvidovre, Hvidovre

DK-6000

Hospital Lillte Belt, Kolding, Kolding

DK-4600

Zealand University Hospital, Køge, Køge

DK-8800

Jutland Central Regional Hospital, Viborg

All Listed Sponsors
collaborator

The Danish Rheumatism Association

OTHER

lead

Central Jutland Regional Hospital

OTHER

NCT03525964 - Individualized Treatment of Acute Achilles Tendon Rupture | Biotech Hunter | Biotech Hunter