Clinical trial NCT03671421: Number One Overall Graft Pick? Hamstring vs Bone-Patellar-Tendon-Bone vs Quadriceps Tendon
Official title: Number One Overall Graft Pick? Hamstring vs Bone-Patellar-Tendon-Bone vs Quadriceps Tendon: A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Keywords: Graft choice
hamstring
quadriceps tendon
Lead sponsor: Panam Clinic
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 297
Sex: ALL
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective quasi-randomized clinical trial
Primary purpose: TREATMENT

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

Eligibility criteria: 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)

Primary outcomes:
measure: graft re-injury (re-rupture, partial tear) or graft failure
timeFrame: 24 months
Secondary outcomes:
measure: SANE
timeFrame: 24 months
measure: Knee laxity
timeFrame: 24 months
measure: Concentric maximal strength
timeFrame: 24 months
measure: Pain log
timeFrame: 3 weeks post operative
measure: ACL-QOL
timeFrame: 24 months
measure: SF-12
timeFrame: 24 months
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Pan Am Clinic
state: Manitoba
Study officials:
References: