Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon

Study Overview
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Brief Summary
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The proposed trial is a multi-centre prospective randomized controlled trial comparing outcomes of patients with acute Achilles tendon ruptures treated either non-operatively or with open operative tendon repair. All patients will undergo accelerated functional rehabilitation. The primary outcome measure is Achilles tendon re-rupture rate.

Detailed Description
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Equivalent clinical outcomes to surgical repair; reduced morbidity and disability to subjects through elimination of a surgical repair; reduction of cost to patients by eliminating need for surgery.

Official Title
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Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon: A Multi-centered Randomized Control Trial Using Standardized Objective and Subjective Outcome Measurement to Determine Rerupture Rate.

Conditions
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Ruptured Achilles Tendon

Intervention / Treatment
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* Procedure: operative
* Procedure: non-operative


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Complete mid-substance rupture of the Achilles tendon as diagnosed on clinical exam Present for initial assessment and treatment with application of a plantar-flexed cast within 48 hours of their injury. Referred to one of the participating orthopaedics surgeons in a timely fashion so as to allow for further treatment (operative repair or initiation of the rehabilitation protocol) within 14 days of their injury. Exclusion Criteria: Open Achilles injury Achilles injury that is not a mid-substance tendon injury Any additional injury to the ipsilateral lower extremity Contraindication to surgery or anesthetic (Physical or mental) that may interfere with compliance with the rehabilitation protocol Any known factor for increased risk of Achilles tendon rupture (i.e. diabetes mellitus, immunosuppressive therapy including local or systemic steroids, and fluoroquinolone use).

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-operative<br>cast applied within 48 hours | Procedure: non-operative<br>* casting within 48 hrs<br>|
| Active Comparator: operative<br>cast applied within 48 hours and surgery within 14 days | Procedure: operative<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative vs non operative Treatment of acute ruptures of Achilles tendon. | The primary outcome measure is Achilles tendon re-rupture rate | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon | 1. The Achilles tendon Total Rupture Score (ATRS) | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Achilles, Rupture