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

NCT03671421 | Active Not Recruiting

• 1 other identifier: B2016:066
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Rupture

Keywords

Graft choice; hamstring; quadriceps tendon

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• SANE

  24 months

• Knee laxity

  24 months

• Concentric maximal strength

  24 months

• Pain log

  3 weeks post operative

• ACL-QOL

  24 months

Study Arms (3)

Quads tendon

ACTIVE COMPARATOR

The graft tissue will be quadriceps tendon

Procedure: ACL reconstruction - graft choice

Hamstring

ACTIVE COMPARATOR

Semitendinosus and gracilis will be used for graft

Procedure: ACL reconstruction - graft choice

BPTB

ACTIVE COMPARATOR

Bone patellar tendon bone graft to be used.

Procedure: ACL reconstruction - graft choice

Interventions

ACL reconstruction - graft choice PROCEDURE

Use of 3 different ipsilateral autograft options

BPTB; Hamstring; Quads tendon

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 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.)

You may not qualify if:

• \- 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)

Sponsors & Collaborators

• Panam Clinic: lead

Study Sites (1)

Pan Am Clinic

Winnipeg, Manitoba, R3M3E4, Canada

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinical assessments will be done by someone blinded to the arm of the study the patient is in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department head, orthopaedic surgery

Model Details: Prospective quasi-randomized clinical trial

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 14, 2018
• Study Start: September 11, 2018
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)