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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2006-05-31

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.

Conditions

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Achilles Tendon Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Protected early weightbearing/Achilles tendon surgery

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Nadr Jomha, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta Division of Orthopaedic Surgery

Amar Suchak, MD

Role: STUDY_DIRECTOR

University of Alberta Department of Medicine and Dentistry

Locations

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University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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JomhaAchillesEdm1

Identifier Type: -

Identifier Source: org_study_id