Non-operative Treatment of Acute Achilles Tendon Rupture: Early Controlled Mobilization Compared With Immobilization
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.
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:
- The intervention group: Must perform controlled mobilization-exercises from the beginning of week 3.
- 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).
Achilles Tendon Rupture
Deep Vein Thrombosis
Procedure: Controlled early mobilization
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Non-operative Treatment of Acute Achilles Tendon Rupture, Early Controlled Mobilization Compared With Immobilization: A Blinded Randomized, Controlled Trial|
- Achilles tendon Total Rupture Score [ Time Frame: 12 months ] [ Designated as safety issue: No ]A patient reported validation score developed to assess symptoms and physical activity after treatment for Achilles tendon rupture.
- Heel-rise work test [ Time Frame: 12 months ] [ Designated as safety issue: No ]Endurance test where the patient stands on one leg and lifts the heel up and down until exhaustion. The number and the height of the heel-rises are counted and measured. The results are then compared to the weight of the patient and the total work is estimated. The MuscleLab ® (Ergo Test Technology, Oslo, Norway) measurement system is used
- Ultrasound length measure [ Time Frame: 12 months ] [ Designated as safety issue: No ]The length between the calcaneus and the distal tip of the medial head of the gastrocnemius muscle.
- Cost effectiveness analysis [ Time Frame: one year ] [ Designated as safety issue: No ]A cost effectiveness analysis will be performed comparing the two treatment protocols.
- DVT screening [ Time Frame: 2 and 8 weeks ] [ Designated as safety issue: Yes ]Ultra sound for deep Vein Thrombosis (DVT) will be performed after 2 and 8 weeks
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||February 2018|
|Estimated Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
Experimental: Controlled early mobilization
The intervention group: Must perform controlled mobilization-exercises from the beginning of week 3 to 8
Procedure: Controlled early mobilization
1. The intervention group: Must perform controlled mobilization-exercises from the beginning of week 3 - 8.
No Intervention: Immobilization
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.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02015364
|Contact: Kristoffer W Barfod, MD||+45 firstname.lastname@example.org|
|Copenhagen University Hospital Hvidovre||Recruiting|
|Hvidovre, Copenhagen, Denmark, 2650|
|Principal Investigator:||Kristoffer W Barfod, MD||Copenhagen University Hospital, Hvidovre|