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Non-operative Treatment of Acute Achilles Tendon Rupture: Early Controlled Mobilization Compared With Immobilization

NCT02015364 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2019-08-13

No results posted yet for this study

Summary

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).

Conditions

  • Achilles Tendon Rupture
  • Deep Vein Thrombosis

Interventions

PROCEDURE

Controlled early mobilization

1\. The intervention group: Must perform controlled mobilization-exercises from the beginning of week 3 - 8.

Sponsors & Collaborators

  • DJO Incorporated

    collaborator INDUSTRY

  • The Danish Rheumatism Association

    collaborator OTHER

  • Hvidovre University Hospital

    lead OTHER

Principal Investigators

  • Kristoffer W Barfod, MD · Copenhagen University Hospital, Hvidovre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02015364 on ClinicalTrials.gov