A Study Comparing Protected Early Weightbearing Versus Non-Weightbearing After Surgery for Achilles Tendon Rupture

Study Overview
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Brief Summary
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The purpose of this study was to determine the effect of protected early weightbearing (PEWB) compared to non-weightbearing (NWB) after surgery for an Achilles tendon rupture (ATR) on health related quality of life (HRQL) in the initial six week period after surgery, functional recovery over time, return to work and activity and complications. We hypothesized that PEWB following ATR repair would result in: i) improved HRQL in the initial postoperative period, ii), a quicker recovery of HRQL, strength and endurance, iii) earlier return to work and sport, and iv) no increase in complications, such as re-rupture compared to NWB.

Detailed Description
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Achilles tendon rupture (ATR) is commonly treated with open surgical repair. Following surgical repair, there are a variety of protocols, ranging from complete immobilization to immediate postoperative mobilization with early weightbearing. However, no clear consensus regarding the optimal postoperative rehabilitation protocol for ATRs exists. Early rehabilitation after ATR has been shown to be beneficial in animal and human studies. Human prospective studies and randomized controlled trials have shown that early postoperative mobilization do not pose additional risks compared to cast immobilization, with a trend toward a reduction in lost work days and an earlier return to sport. However, these trials define early postoperative mobilization differently (i.e. use different combinations of weightbearing and range of motion). This makes it difficult to determine which factor in the early rehabilitation process plays an important role in optimizing recovery. An important component of early rehabilitation is weightbearing. Comparison: Patients weightbearing in the early rehabilitation period after surgical repair of the Achilles tendon compared to patients non-weightbearing after the surgical repair of the Achilles tendon repair. With the exception of weightbearing status, both groups performed the same rehabilitation program.

Official Title
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The Influence of Protected Early Weightbearing Versus Nonweightbearing After Surgical Repair of the Achilles Tendon

Conditions
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Achilles Tendon Rupture

Intervention / Treatment
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* Procedure: Protected early weightbearing/Achilles tendon surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: closed and complete Achilles tendon rupture seen within 14 days of injury in hospital Exclusion Criteria: unwilling to follow the study's rehabilitation protocol unable to speak or read English co-morbid conditions such as diabetes and neurological or collagen disease pregnancy recent immunosuppressant or fluoroquinolone therapy previous Achilles tendon symptoms previous ipsilateral rupture sustained an additional injury not allowing weightbearing an Achilles tendon avulsion injury unfit for surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Protected early weightbearing/Achilles tendon surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life: Short form 36 questionnaire |  | six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life: Short Form-36 questionnaire |  | 3 and 6 months | 
| Level of activity: tailored question |  | six weeks, 3 months, and 6 months | 
| Major complications: chart review |  | 6 weeks, 3 months, and 6 months | 
| Minor complications: chart review |  | 6 weeks, 3 months, and 6 months | 
| Isometric muscle strength: hand held myometer |  | 6 weeks, 3 months, and 6 months | 
| Muscle endurance: heel raise counting device |  | 6 months | 
| Calf circumference: standardized tape measurement |  | 6 weeks, 3 months, and 6 months | 
| Return to work/sport: tailored question |  | 6 weeks, 3 months, and 6 months | 
| Physiotherapy utilization: tailored question |  | 6 weeks, 3 months, and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Achilles tendon rupture, Open surgical repair, Early functional mobilization, Weightbearing, Rehabilitation