Isolated Anterior Cruciate Ligament RuptureNCT01537588
Changes in Muscle Morphology Resulting From Anterior Cruciate Ligament Reconstruction
A study testing Autograft STG harvest from ACL-deficient leg and Autograft harvest contralateral to ACL-deficient leg in people with Isolated Anterior Cruciate Ligament Rupture, run by Panam Clinic at 1 site in Canada.
Trial summary
The aim of this study is to gain new knowledge on the impact of hamstring tendon harvest and apply that knowledge to the treatment and management of patients who undergo anterior cruciate ligament (ACL) reconstruction. There are three main components of this study: 1. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Isolated Anterior Cruciate Ligament Rupture
- What is being tested?
- Autograft STG harvest from ACL-deficient leg and Autograft harvest contralateral to ACL-deficient leg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2009to Jul 2012
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- between 18 and 50 years old; isolated ACL rupture confirmed on MRI
Who cannot join
- other physical or mental health issues that affect ability to complete rehabilitation and/or study follow-ups
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Muscle Morphology Resulting From ACL Reconstruction: Impact on Strength and Function
The aim of this study is to gain new knowledge on the impact of hamstring tendon harvest and apply that knowledge to the treatment and management of patients who undergo anterior cruciate ligament (ACL) reconstruction. There are three main components of this study:
- How do muscle shape, size, strength, and ability to function change following hamstring grafting for ACL reconstruction;
- How does physical activity change following ACL reconstruction;
- Is there a difference in outcome if graft harvest is done from the injured versus uninjured limbs
- Being tested
- Autograft STG harvest from ACL-deficient leg, Autograft harvest contralateral to ACL-deficient leg
- Keywords
- anterior cruciate ligament, hamstring, semitendinosus, gracilis, graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autograft STG harvest from ACL-deficient legOther
Semitendinosus-gracilis graft harvest is undertaken on same limb that is undergoing ACL reconstruction
Autograft harvest contralateral to ACL-deficient legOther
Semitendinosus-gracilis graft harvest is undertaken on limb contralateral to that undergoing ACL reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | ACL reconstruction with autograft harvest of STG from ACL-deficient leg Receives: Other: Autograft STG harvest from ACL-deficient leg |
| Autograft harvest of STG from ACL-deficient leg | Experimental | Autograft harvest of STG from leg contralateral to ACL-deficient leg Receives: Other: Autograft harvest contralateral to ACL-deficient leg |
| Normal matched | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle cross sectional area
Measured on bilateral MRI taken from ischial tuberosity to 10 cm below knee joint line
Measured: 12 months post-surgery
Secondary outcomes (2)
Knee flexion and extension isokinetic strength
Eccentric anc concentric strength measured at 60, 150, and 270 degrees/second on dynamometer in sitting and in 5 degrees hip flexion
Measured: 12-months post-surgery
Physical activity
7-day record of activity using accelerometer.
Measured: 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startJul 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Isolated Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- 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
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panam Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheila McRae, MSc, Principal investigator, University of Manitoba, Pan Am Clinic Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537588
- Sponsor's protocol ID
- April 2009
- Status last verified
- Mar 2015
- First submitted
- 14 Feb 2012
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Muscle Morphology Resulting From ACL Reconstruction: Impact on Strength and Function
- ClinicalTrials.gov ID
- NCT01537588
- Acronym / sponsor ID
- April 2009
- Keywords
- anterior cruciate ligament, hamstring, semitendinosus, gracilis, graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Panam ClinicUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 23 Feb 2012 (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 aim of this study is to gain new knowledge on the impact of hamstring tendon harvest and apply that knowledge to the treatment and management of patients who undergo anterior cruciate ligament (ACL) reconstruction. There are three main components of this study:
- How do muscle shape, size, strength, and ability to function change following hamstring grafting for ACL reconstruction;
- How does physical activity change following ACL reconstruction;
- Is there a difference in outcome if graft harvest is done from the injured versus uninjured limbs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Other: Autograft STG harvest from ACL-deficient legACL reconstruction with autograft harvest of STG from ACL-deficient leg |
| Autograft harvest of STG from ACL-deficient leg | Experimental | Other: Autograft harvest contralateral to ACL-deficient legAutograft harvest of STG from leg contralateral to ACL-deficient leg |
| Normal matched | No intervention | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- between 18 and 50 years old; isolated ACL rupture confirmed on MRI
Key exclusion criteria (1 listed)
- other physical or mental health issues that affect ability to complete rehabilitation and/or study follow-ups
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 |
|---|---|---|
| Autograft STG harvest from ACL-deficient legSemitendinosus-gracilis graft harvest is undertaken on same limb that is undergoing ACL reconstruction | Other | Standard |
| Autograft harvest contralateral to ACL-deficient legSemitendinosus-gracilis graft harvest is undertaken on limb contralateral to that undergoing ACL reconstruction | Other | Autograft harvest of STG from ACL-deficient leg |
Primary outcome
Muscle cross sectional area
Time frame: 12 months post-surgery
Measured on bilateral MRI taken from ischial tuberosity to 10 cm below knee joint line
2 secondary outcomes
Knee flexion and extension isokinetic strength
Time frame: 12-months post-surgery
Physical activity
Time frame: 12 months post-surgery
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 10 Mar 2015.
Related trials for Isolated Anterior Cruciate Ligament Rupture
Recruiting
Combined Intra- and Extra-articular ACL Reconstruction Versus Isolated Intra-articular ACL Reconstruction
Anterior Cruciate Ligament Rupture, Ligament Knee Injury
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.
Sheila McRae, MSc principal investigator
University of Manitoba, Pan Am Clinic Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autograft STG harvest from ACL-deficient leg and Autograft harvest contralateral to ACL-deficient leg in people with Isolated Anterior Cruciate Ligament Rupture, run by Panam Clinic 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 1 inclusion and 1 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 10 Mar 2015. 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?
Muscle cross sectional area (time frame: 12 months post-surgery). 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 10 Mar 2015.