Anterior Cruciate Ligament RuptureNCT03671421
Number One Overall Graft Pick? Hamstring vs Bone-Patellar-Tendon-Bone vs Quadriceps Tendon
A study testing ACL reconstruction - graft choice in people with Anterior Cruciate Ligament Rupture, run by Panam Clinic at 1 site in Canada.
Trial summary
The main purpose of this study is to determine if there is a difference in graft re-injury/failure rates between participants that have had an ACL reconstruction with a STG, BPTB or QT autograft. Read more about this study
- Who is it for?
- Ages 14 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- ACL reconstruction - graft choice
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 297 participants
- Where
- 1 siteCanada
- Study dates
- 11 Sep 2018to 30 Nov 2024
- 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
- - confirmed diagnosis of a complete primary unilateral ACL rupture based on all of the following:
- history of a traumatic injury episode
- physical exam findings of increased anterior translation of the tibia on the femur (Lachman test and/or anterior drawer test)
- positive pivot shift test
- patients must be 14 to </= 50 years (at time of surgery)
- x-rays showing skeletal maturity (i.e. tibial tubercle fused) and no fractures
- MRI prior to surgery (note: if the radiologist's report states an incomplete or partial ACL on MRI but the surgeon diagnoses the patient with a complete unilateral tear based on the clinical criteria above, then the patient will be considered eligible. Final eligibility will be determined intra-operatively.)
Who cannot join
- - ACL rupture on contra-lateral limb
- Partially torn ACL *final determination made intra-operatively
- Concomitant medial collateral, lateral collateral, or posterior collateral ligament tears requiring surgical repair *final determination made intra-operatively
- Severe chondromalacia (Grade IV on the ICRS scale) *final determination made intra-operatively
- ACL reconstruction using allograft tissue
- Confirmed connective tissue disorder
Show all 12Show fewer
- Unwillingness to be followed for 24 months post-operatively
- History of rheumatoid arthritis
- Pregnancy (at the time of surgery)
- Psychiatric illness that precludes informed consent
- Unable to speak, read or understand the English language
- Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Number One Overall Graft Pick? Hamstring vs Bone-Patellar-Tendon-Bone vs Quadriceps Tendon: A Prospective Cohort Study
The main purpose of this study is to determine if there is a difference in graft re-injury/failure rates between participants that have had an ACL reconstruction with a STG, BPTB or QT autograft. Additionally, to compare quality of life, patient reported outcomes and functional performance after ACL reconstruction with STG, BPTB and QT.
Read the detailed description
The main purpose of this study is to determine if there is a difference in graft re-injury/failure rates between participants that have had an ACL reconstruction with a STG, BPTB or QT autograft. Additionally, to compare quality of life, patient reported outcomes and functional performance after ACL reconstruction with STG, BPTB and QT.
Quasi-randomized clinical trial
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- ACL reconstruction - graft choice
- Keywords
- Graft choice, hamstring, quadriceps tendon
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL reconstruction - graft choiceProcedure or surgery
Use of 3 different ipsilateral autograft options
| Study group | Role | What they receive |
|---|---|---|
| Quads tendon | Active comparator | The graft tissue will be quadriceps tendon Receives: Procedure: ACL reconstruction - graft choice |
| Hamstring | Active comparator | Semitendinosus and gracilis will be used for graft Receives: Procedure: ACL reconstruction - graft choice |
| BPTB | Active comparator | Bone patellar tendon bone graft to be used. Receives: Procedure: ACL reconstruction - graft choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
graft re-injury (re-rupture, partial tear) or graft failure
) Diagnosis of a complete graft re-rupture requires all of the following criteria to be met:
- associated with an acute traumatic event
- a definite loss of end point on manual Lachman testing
- increased anterior translation >3 mm
- > or = Grade 2 pivot shift
- tear confirmed as complete on MRI or diagnostic arthroscopy
- revision ACL reconstruction IS recommended or required
- Diagnosis of a partial re-rupture requires all of the following criteria:
- suspected meniscal injury or graft tear on history without the clinical characteristics of a complete rupture
- tear confirmed as partial by MRI or diagnostic arthroscopy
- revision ACL reconstruction is NOT recommended or required
- Diagnosis of graft failure will be defined as:
- >/= Gr. 2 pivot shift and/or >6 mm side-to-side difference on manual Lachman
Measured: 24 months
Secondary outcomes (6)
SANE
Measured: 24 months
Knee laxity
KT1000 Knee Laxity Arthrometer
Measured: 24 months
Concentric maximal strength
Knee flexion and extension strength - biodex
Measured: 24 months
Pain log
type and quantity of pain medication use
Measured: 3 weeks post operative
ACL-QOL
Measured: 24 months
SF-12
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start11 Sep 2018
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective quasi-randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panam Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter MacDonald, Panam Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671421
- Sponsor's protocol ID
- B2016:066
- Status last verified
- Apr 2024
- First submitted
- 11 Sep 2018
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Number One Overall Graft Pick? Hamstring vs Bone-Patellar-Tendon-Bone vs Quadriceps Tendon: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03671421
- Acronym / sponsor ID
- B2016:066
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- Graft choice, hamstring, quadriceps tendon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Panam ClinicUniversity, hospital or other
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 14 Sep 2018 (actual)
- 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 main purpose of this study is to determine if there is a difference in graft re-injury/failure rates between participants that have had an ACL reconstruction with a STG, BPTB or QT autograft. Additionally, to compare quality of life, patient reported outcomes and functional performance after ACL reconstruction with STG, BPTB and QT.
Detailed description
The main purpose of this study is to determine if there is a difference in graft re-injury/failure rates between participants that have had an ACL reconstruction with a STG, BPTB or QT autograft. Additionally, to compare quality of life, patient reported outcomes and functional performance after ACL reconstruction with STG, BPTB and QT.
Quasi-randomized clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective quasi-randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Quads tendon | Active comparator | Procedure: ACL reconstruction - graft choiceThe graft tissue will be quadriceps tendon |
| Hamstring | Active comparator | Procedure: ACL reconstruction - graft choiceSemitendinosus and gracilis will be used for graft |
| BPTB | Active comparator | Procedure: ACL reconstruction - graft choiceBone patellar tendon bone graft to be used. |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- - confirmed diagnosis of a complete primary unilateral ACL rupture based on all of the following:
- history of a traumatic injury episode
- physical exam findings of increased anterior translation of the tibia on the femur (Lachman test and/or anterior drawer test)
- positive pivot shift test
- patients must be 14 to </= 50 years (at time of surgery)
Key exclusion criteria (12 listed)
- - ACL rupture on contra-lateral limb
- Partially torn ACL *final determination made intra-operatively
- Concomitant medial collateral, lateral collateral, or posterior collateral ligament tears requiring surgical repair *final determination made intra-operatively
- Severe chondromalacia (Grade IV on the ICRS scale) *final determination made intra-operatively
- ACL reconstruction using allograft tissue
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 |
|---|---|---|
| ACL reconstruction - graft choiceUse of 3 different ipsilateral autograft options | Procedure or surgery | BPTB, Hamstring, Quads tendon |
Primary outcome
graft re-injury (re-rupture, partial tear) or graft failure
Time frame: 24 months
) Diagnosis of a complete graft re-rupture requires all of the following criteria to be met: * associated with an acute traumatic event * a definite loss of end point on manual Lachman testing * increased anterior translation >3 mm * > or = Grade 2 pivot shift * tear confirmed as complete on MRI or diagnostic arthroscopy * revision ACL reconstruction IS recommended or required 2) Diagnosis of a partial re-rupture requires all of the following criteria: * suspected meniscal injury or graft tear on history without the clinical characteristics of a complete rupture * tear confirmed as partial by MRI or diagnostic arthroscopy * revision ACL reconstruction is NOT recommended or required 3) Diagnosis of graft failure will be defined as: * >/= Gr. 2 pivot shift and/or >6 mm side-to-side difference on manual Lachman
6 secondary outcomes
SANE
Time frame: 24 months
Knee laxity
Time frame: 24 months
Concentric maximal strength
Time frame: 24 months
Pain log
Time frame: 3 weeks post operative
ACL-QOL
Time frame: 24 months
SF-12
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACL reconstruction - graft choice in people with 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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 2 Apr 2024. 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?
Results are not available in the source record.
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?
graft re-injury (re-rupture, partial tear) or graft failure (time frame: 24 months). 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 2 Apr 2024; AzTrials last refreshed its copy on 29 Oct 2026.