Skip to main content
Clinical Trials/NCT00489749
NCT00489749
Completed
Not Applicable

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

University of Alberta1 site in 1 country110 target enrollmentOctober 2003

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Achilles Tendon Rupture
Sponsor
University of Alberta
Enrollment
110
Locations
1
Primary Endpoint
Health related quality of life: Short form 36 questionnaire
Status
Completed
Last Updated
18 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
October 2003
End Date
May 2006
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Health related quality of life: Short form 36 questionnaire

Time Frame: six weeks

Secondary Outcomes

  • 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)

Study Sites (1)

Loading locations...

Similar Trials