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

This study has been completed.
Sponsor:
Collaborators:
Royal Alexandra Hospital
Edmonton Orthopaedic Research Society
Don Joy Orthotics
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00489749
First received: June 19, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  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

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Health related quality of life: Short form 36 questionnaire [ Time Frame: six weeks ]

Secondary Outcome Measures:
  • 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
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489749

Locations
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Royal Alexandra Hospital
Edmonton Orthopaedic Research Society
Don Joy Orthotics
Investigators
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 October 21, 2014