A Study Comparing Protected Early Weightbearing Versus Non-Weightbearing After Surgery for Achilles Tendon Rupture
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Achilles Tendon Rupture |
Procedure: Protected early weightbearing/Achilles tendon surgery |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | The Influence of Protected Early Weightbearing Versus Nonweightbearing After Surgical Repair of the Achilles Tendon |
- Health related quality of life: Short form 36 questionnaire [ Time Frame: six weeks ]
- Health related quality of life: Short Form-36 questionnaire [ Time Frame: 3 and 6 months ]
- Level of activity: tailored question [ Time Frame: six weeks, 3 months, and 6 months ]
- Major complications: chart review [ Time Frame: 6 weeks, 3 months, and 6 months ]
- Minor complications: chart review [ Time Frame: 6 weeks, 3 months, and 6 months ]
- Isometric muscle strength: hand held myometer [ Time Frame: 6 weeks, 3 months, and 6 months ]
- Muscle endurance: heel raise counting device [ Time Frame: 6 months ]
- Calf circumference: standardized tape measurement [ Time Frame: 6 weeks, 3 months, and 6 months ]
- Return to work/sport: tailored question [ Time Frame: 6 weeks, 3 months, and 6 months ]
- Physiotherapy utilization: tailored question [ Time Frame: 6 weeks, 3 months, and 6 months ]
| Enrollment: | 110 |
| Study Start Date: | October 2003 |
| Study Completion Date: | May 2006 |
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Canada, Alberta | |
| University of Alberta Hospital | |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00489749 History of Changes |
| Other Study ID Numbers: | JomhaAchillesEdm1 |
| Study First Received: | June 19, 2007 |
| Last Updated: | June 19, 2007 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University of Alberta:
|
Achilles tendon rupture Open surgical repair Early functional mobilization Weightbearing Rehabilitation |
Additional relevant MeSH terms:
|
Rupture Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013