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

Not Applicable
Completed
Conditions
Achilles Tendon Rupture
Registration Number
NCT00489749
Lead Sponsor
University of Alberta
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
110
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Health related quality of life: Short form 36 questionnairesix weeks
Secondary Outcome Measures
NameTimeMethod
Health related quality of life: Short Form-36 questionnaire3 and 6 months
Level of activity: tailored questionsix weeks, 3 months, and 6 months
Major complications: chart review6 weeks, 3 months, and 6 months
Minor complications: chart review6 weeks, 3 months, and 6 months
Isometric muscle strength: hand held myometer6 weeks, 3 months, and 6 months
Muscle endurance: heel raise counting device6 months
Calf circumference: standardized tape measurement6 weeks, 3 months, and 6 months
Return to work/sport: tailored question6 weeks, 3 months, and 6 months
Physiotherapy utilization: tailored question6 weeks, 3 months, and 6 months

Trial Locations

Locations (1)

University of Alberta Hospital

🇨🇦

Edmonton, Alberta, Canada

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