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

Anterior Cruciate Ligament Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03671421
• Other study ID #: B2016:066
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 11, 2018
• Est. completion date: November 30, 2024

Study information

• Verified date: April 2024
• Source: Panam Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 297
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Rupture
• Rupture

Intervention

Procedure:
• ACL reconstruction - graft choice
Use of 3 different ipsilateral autograft options

Locations

Country	Name	City	State
Canada	Pan Am Clinic	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Panam Clinic

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	SANE		24 months
Secondary	Knee laxity	KT1000 Knee Laxity Arthrometer	24 months
Secondary	Concentric maximal strength	Knee flexion and extension strength - biodex	24 months
Secondary	Pain log	type and quantity of pain medication use	3 weeks post operative
Secondary	ACL-QOL		24 months
Secondary	SF-12		24 months