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

June 19, 2007 updated by: University of Alberta

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Royal Alexandra Hospital
Edmonton Orthopaedic Research Society
DonJoy Orthotics

Investigators

  • Principal Investigator: Nadr Jomha, MD, PhD, University of Alberta Division of Orthopaedic Surgery
  • Study Director: Amar Suchak, MD, University of Alberta Department of Medicine and Dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

June 19, 2007

First Submitted That Met QC Criteria

June 19, 2007

First Posted (Estimate)

June 21, 2007

Study Record Updates

Last Update Posted (Estimate)

June 21, 2007

Last Update Submitted That Met QC Criteria

June 19, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JomhaAchillesEdm1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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