Number One Overall Graft Pick? Hamstring vs Bone-Patellar-Tendon-Bone vs Quadriceps Tendon (NCT03671421) | Clinical Trial Compass
UnknownNot Applicable
Number One Overall Graft Pick? Hamstring vs Bone-Patellar-Tendon-Bone vs Quadriceps Tendon
Canada297 participantsStarted 2018-09-11
Plain-language 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.
Who can participate
Age range14 Years – 50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 med…
What they're measuring
1
graft re-injury (re-rupture, partial tear) or graft failure