Medium Term Outcome of Nonoperative Treatment After Achilles Tendon Rupture.

Study Overview
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Brief Summary
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A total of 56 patients completed a previous study regarding non-operative treatment for acute achilles tendon rupture. This study consists of an additional follow up after 4-5 years depending on original date of injury.

Detailed Description
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30 patients suffering from acute Achilles tendon rupture was originally randomized to each arm, and followed up after 6 and 12 months. Of these a total of 56 patients was included in the final analysis, and invited to participate in this additional follow-up, 4-5 years after their original injury. Originally patients was monitored using: ATRS questionnaires, ATRA: Achilles Tendon Resting Angle, Heel Raise Work: number of lifts, lift height and total work, and tests of strength and stiffness in the ankle using a kinetic dynamometer.

Official Title
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Medium Term Outcome of Nonoperative Dynamic Treatment of Acute Achilles Tendon Rupture: the Influence of Early Weight-bearing on Clinical Outcome: a Blinded, Randomized Controlled Trial.

Conditions
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Achilles Tendon Rupture

Intervention / Treatment
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* Behavioral: Early weight bearing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suffered acute Achilles tendon rupture from April 2011 to March 2012, and then referred to Copenhagen University Hospital Hvidovre. Participated and completed the original study. The patient must be able to speak and understand Danish, as well as be capable to give informed consent to participating. Exclusion Criteria: Terminal disease or serious illnesses with an ASA score of 3 or above. Any injury significantly influencing gate and function of the lower extremities other than re-rupture of the Achilles tendon.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early Weight Bearing<br>Ankle immobilized with orthosis (DJO Nextep Contour 2 Walker) with 3 1.5 cm wedges in the heel, fixing the angle between 20-30 degrees. The orthosis was used for 8 weeks, gradually removing the wedges. Full weight bearing was allowed from day 1. The orthosis was worn 24 hours / day the first 2 weeks. From week 2 controlled motion exercises and removal of the orthosis 5 times a day. | Behavioral: Early weight bearing<br>* The intervention implies that the selected patients, will be allowed to bear weight on the injured leg form day 1 while wearing the orthosis, in contrast to the control group, who must wait 6 weaks.<br>|
| Control<br>Ankle immobilized with orthosis (DJO Nextep Contour 2 Walker) with 3 1.5 cm wedges in the heel, fixing the angle between 20-30 degrees. The orthosis was used for 8 weeks, gradually removing the wedges. Weight bearing was allowed from week 6. The orthosis was worn 24 hours / day the first 2 weeks. From week 2 controlled motion exercises and removal of the orthosis 5 times a day. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ATRS: Achilles Tendon Rupture Score | From initial test 6 and 12 months after injury, and now 4-5 years after. | approximate 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heel Raise Work | The total work (joules), max height of lift (mm) and number of lifts is recorded. THe patient is placed standing on one leg on a platform tilted 10 degrees (heel below toes), and is asked to lift the heel (and thereby bodyweight) as high as possible, once every 2 seconds. When the patient can no longer maintain height or pace, the test is finished. | Test is performed once, 4-5 years after the initial injury | 
| return to sport and return to work | When did the patients return to work full or part time, and when did they take up sports again. | 4-5 years after the initial injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Achilles Tendon Rupture, Conservative treatment, early weight bearing, Dynamic, ATRS, ATRA, Heel Raise Work