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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anterior Cruciate Ligament Rupture
• Intervention / Treatment: Procedure: ACL reconstruction - graft choice

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

• Study Type: Interventional
• Enrollment (Actual): 297
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M3E4
      • Pan Am Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Quads tendon; The graft tissue will be quadriceps tendon	Procedure: ACL reconstruction - graft choice; Use of 3 different ipsilateral autograft options
Active Comparator: Hamstring; Semitendinosus and gracilis will be used for graft	Procedure: ACL reconstruction - graft choice; Use of 3 different ipsilateral autograft options
Active Comparator: BPTB; Bone patellar tendon bone graft to be used.	Procedure: ACL reconstruction - graft choice; Use of 3 different ipsilateral autograft options

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 required2) 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 required3) 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Panam Clinic

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2018
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: quadriceps tendon; hamstring; Graft choice
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: B2016:066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No