Extrait

Study objectives To investigate if early controlled mobilization of the ankle in week 3 to 8 affects the functional outcome and patient reported outcome after treatment of acute Achilles tendon rupture. Type of study Randomized, controlled trial (RCT). 130 patients will be included. Time schedule Begins January 2014. Study period is 4-5 years; recruitment is expected to span 2 years Setup At Copenhagen University Hospital Hvidovre the majority of patients with acute ATR are treated non-operatively. A cast is applied in the emergency room. After 2 weeks the bandage is changed to a removable orthosis and full weight bearing is allowed. Patients who choose to participate in the trial will - through randomisation - be placed in one of the two groups: 1. The intervention group: Must perform controlled mobilization-exercises from the beginning of week 3. 2. The control group: In line with the current treatment regimen the patients must keep the boot on at all times and they are not allowed to move the ankle. Treatment protocol for the two groups is similar concerning orthose, removal of wedges and weight-bearing. The only difference is that patients in the intervention group are instructed to do ankle exercise. Post-examinations in relation to the study Follow-up is done at 8 and 16 weeks plus 6 and 12 months. The study's primary endpoint is at the 12 month mark. Population Patients who are treated for acute Achilles tendon rupture at Copenhagen University Hospital Hvidovre. Patients who fulfil the inclusion criteria but do not wish to participate are treated according the standard regimen (non-operatively without early controlled movement of the ankle joint). Number of patients 65 patients will be included in each group (a 130 patients in total).

Critère d'inclusion

• Achilles Tendon Rupture,Deep vein thrombosis

Liens

• ictrp
• nct