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

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ClinicalTrials.gov Identifier: NCT03671421
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Peter MacDonald, Panam Clinic

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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Rupture Procedure: ACL reconstruction - graft choice Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 286 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective quasi-randomized clinical trial
Masking: Single (Outcomes Assessor)
Masking Description: The clinical assessments will be done by someone blinded to the arm of the study the patient is in.
Primary Purpose: Treatment
Official Title: Number One Overall Graft Pick? Hamstring vs Bone-Patellar-Tendon-Bone vs Quadriceps Tendon: A Prospective Cohort Study
Actual Study Start Date : September 11, 2018
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

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




Primary Outcome Measures :
  1. graft re-injury (re-rupture, partial tear) or graft failure [ Time Frame: 24 months ]

    ) 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


Secondary Outcome Measures :
  1. SANE [ Time Frame: 24 months ]
  2. Knee laxity [ Time Frame: 24 months ]
    KT1000 Knee Laxity Arthrometer

  3. Concentric maximal strength [ Time Frame: 24 months ]
    Knee flexion and extension strength - biodex

  4. Pain log [ Time Frame: 3 weeks post operative ]
    type and quantity of pain medication use

  5. ACL-QOL [ Time Frame: 24 months ]
  6. SF-12 [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671421


Locations
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Canada, Manitoba
Pan Am Clinic Recruiting
Winnipeg, Manitoba, Canada, R3M3E4
Contact: Sheila McRae, MSc, PhD    204.925.7469    smcrae@panamclinic.com   
Contact: Dean Cordingley, MSc    204.925.5858    dcordingley@panamclinic.com   
Sub-Investigator: Sheila McRae, MSc, PhD(C)         
Sub-Investigator: Greg Stranges, MD, FRCSC         
Principal Investigator: Peter MacDonald, MD, FRCSC         
Principal Investigator: Jarret Woodmass, MD, FRCSC         
Sponsors and Collaborators
Panam Clinic
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Responsible Party: Peter MacDonald, Department head, orthopaedic surgery, Panam Clinic
ClinicalTrials.gov Identifier: NCT03671421    
Other Study ID Numbers: B2016:066
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter MacDonald, Panam Clinic:
Graft choice
hamstring
quadriceps tendon
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries