A Study Comparing Protected Early Weightbearing Versus Non-Weightbearing After Surgery for Achilles Tendon Rupture
Primary Purpose
Achilles Tendon Rupture
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Protected early weightbearing/Achilles tendon surgery
Sponsored by
About this trial
This is an interventional treatment trial for Achilles Tendon Rupture focused on measuring Achilles tendon rupture, Open surgical repair, Early functional mobilization, Weightbearing, Rehabilitation
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
Sites / Locations
- University of Alberta Hospital
Outcomes
Primary Outcome Measures
Health related quality of life: Short form 36 questionnaire
Secondary Outcome Measures
Health related quality of life: Short Form-36 questionnaire
Level of activity: tailored question
Major complications: chart review
Minor complications: chart review
Isometric muscle strength: hand held myometer
Muscle endurance: heel raise counting device
Calf circumference: standardized tape measurement
Return to work/sport: tailored question
Physiotherapy utilization: tailored question
Full Information
NCT ID
NCT00489749
First Posted
June 19, 2007
Last Updated
June 19, 2007
Sponsor
University of Alberta
Collaborators
Royal Alexandra Hospital, Edmonton Orthopaedic Research Society, DonJoy Orthotics
1. Study Identification
Unique Protocol Identification Number
NCT00489749
Brief Title
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
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Alberta
Collaborators
Royal Alexandra Hospital, Edmonton Orthopaedic Research Society, DonJoy Orthotics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Rupture
Keywords
Achilles tendon rupture, Open surgical repair, Early functional mobilization, Weightbearing, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Protected early weightbearing/Achilles tendon surgery
Primary Outcome Measure Information:
Title
Health related quality of life: Short form 36 questionnaire
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
Health related quality of life: Short Form-36 questionnaire
Time Frame
3 and 6 months
Title
Level of activity: tailored question
Time Frame
six weeks, 3 months, and 6 months
Title
Major complications: chart review
Time Frame
6 weeks, 3 months, and 6 months
Title
Minor complications: chart review
Time Frame
6 weeks, 3 months, and 6 months
Title
Isometric muscle strength: hand held myometer
Time Frame
6 weeks, 3 months, and 6 months
Title
Muscle endurance: heel raise counting device
Time Frame
6 months
Title
Calf circumference: standardized tape measurement
Time Frame
6 weeks, 3 months, and 6 months
Title
Return to work/sport: tailored question
Time Frame
6 weeks, 3 months, and 6 months
Title
Physiotherapy utilization: tailored question
Time Frame
6 weeks, 3 months, and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadr Jomha, MD, PhD
Organizational Affiliation
University of Alberta Division of Orthopaedic Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amar Suchak, MD
Organizational Affiliation
University of Alberta Department of Medicine and Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
12. IPD Sharing Statement
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A Study Comparing Protected Early Weightbearing Versus Non-Weightbearing After Surgery for Achilles Tendon Rupture
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