Clinical trial NCT00489749: A Study Comparing Protected Early Weightbearing Versus Non-Weightbearing After Surgery for Achilles Tendon Rupture
Official title: The Influence of Protected Early Weightbearing Versus Nonweightbearing After Surgical Repair of the Achilles Tendon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achilles Tendon Rupture
Keywords: Achilles tendon rupture
Open surgical repair
Early functional mobilization
Weightbearing
Rehabilitation
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Royal Alexandra Hospital
name: Edmonton Orthopaedic Research Society
name: DonJoy Orthotics
First posted: 2007-06-21
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Health related quality of life: Short form 36 questionnaire
timeFrame: six weeks
Secondary outcomes:
measure: Health related quality of life: Short Form-36 questionnaire
timeFrame: 3 and 6 months
measure: Level of activity: tailored question
timeFrame: six weeks, 3 months, and 6 months
measure: Major complications: chart review
timeFrame: 6 weeks, 3 months, and 6 months
measure: Minor complications: chart review
timeFrame: 6 weeks, 3 months, and 6 months
measure: Isometric muscle strength: hand held myometer
timeFrame: 6 weeks, 3 months, and 6 months
measure: Muscle endurance: heel raise counting device
timeFrame: 6 months
measure: Calf circumference: standardized tape measurement
timeFrame: 6 weeks, 3 months, and 6 months
measure: Return to work/sport: tailored question
timeFrame: 6 weeks, 3 months, and 6 months
measure: Physiotherapy utilization: tailored question
timeFrame: 6 weeks, 3 months, and 6 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: University of Alberta Division of Orthopaedic Surgery
name: Nadr Jomha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta Department of Medicine and Dentistry
name: Amar Suchak, MD
role: STUDY_DIRECTOR
References: