Number One Overall Graft Pick? Hamstring vs Bone-Patellar-Tendon-Bone vs Quadriceps Tendon

Study Overview
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Brief Summary
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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
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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

Official Title
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Number One Overall Graft Pick? Hamstring vs Bone-Patellar-Tendon-Bone vs Quadriceps Tendon: A Prospective Cohort Study

Conditions
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Anterior Cruciate Ligament Rupture

Intervention / Treatment
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* Procedure: ACL reconstruction - graft choice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 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.) Exclusion Criteria: - 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 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)

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective quasi-randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quads tendon<br>The graft tissue will be quadriceps tendon | Procedure: ACL reconstruction - graft choice<br>* Use of 3 different ipsilateral autograft options<br>|
| Active Comparator: Hamstring<br>Semitendinosus and gracilis will be used for graft | Procedure: ACL reconstruction - graft choice<br>* Use of 3 different ipsilateral autograft options<br>|
| Active Comparator: BPTB<br>Bone patellar tendon bone graft to be used. | Procedure: ACL reconstruction - graft choice<br>* Use of 3 different ipsilateral autograft options<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SANE |  | 24 months | 
| Knee laxity | KT1000 Knee Laxity Arthrometer | 24 months | 
| Concentric maximal strength | Knee flexion and extension strength - biodex | 24 months | 
| Pain log | type and quantity of pain medication use | 3 weeks post operative | 
| ACL-QOL |  | 24 months | 
| SF-12 |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Graft choice, hamstring, quadriceps tendon