Anterior Cruciate Ligament ReconstructionNCT02633410
Transtibial Versus Anteromedial Femoral Tunnel Technique in ACL Reconstruction
A study testing Femoral tunnel creation in people with Anterior Cruciate Ligament Reconstruction, run by Panam Clinic.
Trial summary
The anteromedial (AM) portal technique was introduced to position the femoral tunnel in anterior cruciate ligament (ACL) reconstruction to more closely replicate the original footprint compared to the transtibial (TT) approach.1-5 Few randomized trials have evaluated differences in these techniques with respect to… Read more about this study
- Who is it for?
- Ages 14 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Femoral tunnel creation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Jul 2015
- 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 14 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- sustained a complete ACL tear and had no other ligament injuries requiring surgical intervention
Who cannot join
- concomitant collateral ligament tears
- significant chondromalacia (based on diagnostic imaging)
- previous lower limb surgery
- significant injury to either lower limb requiring surgery
- history of arthritis
- were unable to comply with rehabilitation protocols or study follow-ups
- were pregnant females or had other medical conditions which precluded participation.
About this study
Official title: Prospective Randomized Clinical Study Comparing Anteromedial Portal Versus Transtibial Technique for Femoral Tunnel Positioning in Anterior Cruciate Ligament Reconstruction With Hamstring Autograft
The anteromedial (AM) portal technique was introduced to position the femoral tunnel in anterior cruciate ligament (ACL) reconstruction to more closely replicate the original footprint compared to the transtibial (TT) approach.1-5 Few randomized trials have evaluated differences in these techniques with respect to clinical outcomes. The purpose of this study was to determine if there are any differences in clinical outcome between the AM and TT approaches.
Read the detailed description
The anteromedial (AM) portal technique was introduced to position the femoral tunnel in anterior cruciate ligament (ACL) reconstruction to more closely replicate the original footprint compared to the transtibial (TT) approach.1-5 Few randomized trials have evaluated differences in these techniques with respect to clinical outcomes. The purpose of this study was to determine if there are any differences in clinical outcome between the AM and TT approaches.
- Being tested
- Femoral tunnel creation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral tunnel creationProcedure or surgery
Arthroscopic surgery approach used to create tunnel in femur into which graft is positioned
| Study group | Role | What they receive |
|---|---|---|
| Transtibial | Active comparator | Transtibial technique used to create femoral tunnel Receives: Procedure: Femoral tunnel creation |
| Anteromedial | Active comparator | Anteromedial technique used to create femoral tunnel Receives: Procedure: Femoral tunnel creation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior cruciate ligament quality of life
Measured: 24-months postoperative
Secondary outcomes (2)
KT-1000
Measured: 24-months post-operative
Knee range of motion
Measured: 24-months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startJul 2007
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies 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
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panam Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto
- Responsible party
- Sponsor
- Investigators
- Peter MacDonald, MD FRCSC, Principal investigator, Pan Am CLinic/University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633410
- Sponsor's protocol ID
- ACL-FEM 01
- Status last verified
- Dec 2015
- First submitted
- 15 Dec 2015
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Study Comparing Anteromedial Portal Versus Transtibial Technique for Femoral Tunnel Positioning in Anterior Cruciate Ligament Reconstruction With Hamstring Autograft
- ClinicalTrials.gov ID
- NCT02633410
- Acronym / sponsor ID
- ACL-FEM 01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Panam ClinicUniversity, hospital or other
- Collaborators
- Unity Health Toronto
- Study start
- Jul 2007
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 17 Dec 2015 (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 anteromedial (AM) portal technique was introduced to position the femoral tunnel in anterior cruciate ligament (ACL) reconstruction to more closely replicate the original footprint compared to the transtibial (TT) approach.1-5 Few randomized trials have evaluated differences in these techniques with respect to clinical outcomes. The purpose of this study was to determine if there are any differences in clinical outcome between the AM and TT approaches.
Detailed description
The anteromedial (AM) portal technique was introduced to position the femoral tunnel in anterior cruciate ligament (ACL) reconstruction to more closely replicate the original footprint compared to the transtibial (TT) approach.1-5 Few randomized trials have evaluated differences in these techniques with respect to clinical outcomes. The purpose of this study was to determine if there are any differences in clinical outcome between the AM and TT approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transtibial | Active comparator | Procedure: Femoral tunnel creationTranstibial technique used to create femoral tunnel |
| Anteromedial | Active comparator | Procedure: Femoral tunnel creationAnteromedial technique used to create femoral tunnel |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- sustained a complete ACL tear and had no other ligament injuries requiring surgical intervention
Key exclusion criteria (7 listed)
- concomitant collateral ligament tears
- significant chondromalacia (based on diagnostic imaging)
- previous lower limb surgery
- significant injury to either lower limb requiring surgery
- history of arthritis
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 |
|---|---|---|
| Femoral tunnel creationArthroscopic surgery approach used to create tunnel in femur into which graft is positioned | Procedure or surgery | Anteromedial, Transtibial |
Primary outcome
Anterior cruciate ligament quality of life
Time frame: 24-months postoperative
2 secondary outcomes
KT-1000
Time frame: 24-months post-operative
Knee range of motion
Time frame: 24-months post-operative
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 17 Dec 2015.
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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.
Peter MacDonald, MD FRCSC principal investigator
Pan Am CLinic/University of Manitoba
Questions about this trial
What is this clinical trial studying?
A study testing Femoral tunnel creation in people with Anterior Cruciate Ligament Reconstruction, run by Panam Clinic.
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 7 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 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Anterior cruciate ligament quality of life (time frame: 24-months postoperative). 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 17 Dec 2015.