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

Achilles Tendon Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489749
• Other study ID #: JomhaAchillesEdm1
• Status: Completed
• Phase: N/A
• First received: June 19, 2007
• Last updated: June 19, 2007
• Start date: October 2003
• Est. completion date: May 2006

Study information

• Verified date: June 2007
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Rupture

Intervention

Procedure:
• Protected early weightbearing/Achilles tendon surgery

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (4)

Lead Sponsor	Collaborator
University of Alberta	DonJoy Orthotics, Edmonton Orthopaedic Research Society, Royal Alexandra Hospital

Country where clinical trial is conducted

Canada, 

Outcome

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