Number One Overall Graft Pick? Hamstring vs Bone-Patellar-Tendon-Bone vs Quadriceps Tendon
- Conditions
- Anterior Cruciate Ligament Rupture
- Interventions
- Procedure: ACL reconstruction - graft choice
- Registration Number
- NCT03671421
- Lead Sponsor
- Panam Clinic
- Brief 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. 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 297
-
- 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.)
-
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Quads tendon ACL reconstruction - graft choice The graft tissue will be quadriceps tendon BPTB ACL reconstruction - graft choice Bone patellar tendon bone graft to be used. Hamstring ACL reconstruction - graft choice Semitendinosus and gracilis will be used for graft
- Primary Outcome Measures
Name Time Method graft re-injury (re-rupture, partial tear) or graft failure 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
- Secondary Outcome Measures
Name Time Method Concentric maximal strength 24 months Knee flexion and extension strength - biodex
Pain log 3 weeks post operative type and quantity of pain medication use
Knee laxity 24 months KT1000 Knee Laxity Arthrometer
ACL-QOL 24 months SANE 24 months SF-12 24 months
Trial Locations
- Locations (1)
Pan Am Clinic
🇨🇦Winnipeg, Manitoba, Canada