Achilles Tendon RuptureNCT00489749
A Study Comparing Protected Early Weightbearing Versus Non-Weightbearing After Surgery for Achilles Tendon Rupture
A study testing Protected early weightbearing/Achilles tendon surgery in people with Achilles Tendon Rupture, run by University of Alberta at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Achilles Tendon Rupture
- What is being tested?
- Protected early weightbearing/Achilles tendon surgery
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2003to May 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- closed and complete Achilles tendon rupture
- seen within 14 days of injury in hospital
Who cannot join
- 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
Show all 10Show fewer
- previous ipsilateral rupture
- sustained an additional injury not allowing weightbearing
- an Achilles tendon avulsion injury
- unfit for surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Protected Early Weightbearing Versus Nonweightbearing After Surgical Repair of the Achilles Tendon
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.
Read the 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.
- Conditions
- Achilles Tendon Rupture
- Being tested
- Protected early weightbearing/Achilles tendon surgery
- Keywords
- Achilles tendon rupture, Open surgical repair, Early functional mobilization, Weightbearing, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protected early weightbearing/Achilles tendon surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life: Short form 36 questionnaire
Measured: six weeks
Secondary outcomes (9)
Health related quality of life: Short Form-36 questionnaire
Measured: 3 and 6 months
Level of activity: tailored question
Measured: six weeks, 3 months, and 6 months
Major complications: chart review
Measured: 6 weeks, 3 months, and 6 months
Minor complications: chart review
Measured: 6 weeks, 3 months, and 6 months
Isometric muscle strength: hand held myometer
Measured: 6 weeks, 3 months, and 6 months
Muscle endurance: heel raise counting device
Measured: 6 months
Calf circumference: standardized tape measurement
Measured: 6 weeks, 3 months, and 6 months
Return to work/sport: tailored question
Measured: 6 weeks, 3 months, and 6 months
Physiotherapy utilization: tailored question
Measured: 6 weeks, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startOct 2003
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendon RuptureStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Alexandra Hospital, Edmonton Orthopaedic Research Society, DonJoy Orthotics
- Investigators
- Nadr Jomha, MD, PhD, Principal investigator, University of Alberta Division of Orthopaedic SurgeryAmar Suchak, MD, Study director, University of Alberta Department of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489749
- Sponsor's protocol ID
- JomhaAchillesEdm1
- Status last verified
- Jun 2007
- First submitted
- 19 Jun 2007
- Last updated
- 21 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Protected Early Weightbearing Versus Nonweightbearing After Surgical Repair of the Achilles Tendon
- ClinicalTrials.gov ID
- NCT00489749
- Acronym / sponsor ID
- JomhaAchillesEdm1
- Conditions
- Achilles Tendon Rupture
- Keywords
- Achilles tendon rupture, Open surgical repair, Early functional mobilization, Weightbearing, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Royal Alexandra Hospital, Edmonton Orthopaedic Research Society, DonJoy Orthotics
- Study start
- Oct 2003
- Study completion
- May 2006 (actual)
- First posted
- 21 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- closed and complete Achilles tendon rupture
- seen within 14 days of injury in hospital
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protected early weightbearing/Achilles tendon surgery | Procedure or surgery | – |
Primary outcome
Health related quality of life: Short form 36 questionnaire
Time frame: six weeks
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadr Jomha, MD, PhD principal investigator
University of Alberta Division of Orthopaedic Surgery
Amar Suchak, MD study director
University of Alberta Department of Medicine and Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protected early weightbearing/Achilles tendon surgery in people with Achilles Tendon Rupture, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life: Short form 36 questionnaire (time frame: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2007.