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

Panam Clinic

Status: Active, not recruiting

Conditions: Anterior Cruciate Ligament Rupture

Treatments: Procedure: ACL reconstruction - graft choice

Study type: Interventional

Funder types: Other

Identifiers

NCT03671421

B2016:066

Details and patient eligibility

About

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.

Full 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

Enrollment: 297 patients

Sex: All

Ages: 14 to 50 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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297 participants in 3 patient groups

Quads tendon

Active Comparator group

Description:

The graft tissue will be quadriceps tendon

Treatment:

Procedure: ACL reconstruction - graft choice

Hamstring

Active Comparator group

Description:

Semitendinosus and gracilis will be used for graft

Treatment:

Procedure: ACL reconstruction - graft choice

BPTB

Active Comparator group

Description:

Bone patellar tendon bone graft to be used.

Treatment:

Procedure: ACL reconstruction - graft choice