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

Primary Purpose

Anterior Cruciate Ligament Rupture

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ACL reconstruction - graft choice
Sponsored by
Panam Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Rupture focused on measuring Graft choice, hamstring, quadriceps tendon

Eligibility Criteria

14 Years - 50 Years (Child, Adult)All SexesDoes not accept 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)

Sites / Locations

  • Pan Am Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Quads tendon

Hamstring

BPTB

Arm Description

The graft tissue will be quadriceps tendon

Semitendinosus and gracilis will be used for graft

Bone patellar tendon bone graft to be used.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

SANE
Knee laxity
KT1000 Knee Laxity Arthrometer
Concentric maximal strength
Knee flexion and extension strength - biodex
Pain log
type and quantity of pain medication use
ACL-QOL
SF-12

Full Information

First Posted
September 11, 2018
Last Updated
March 7, 2023
Sponsor
Panam Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03671421
Brief Title
Number One Overall Graft Pick? Hamstring vs Bone-Patellar-Tendon-Bone vs Quadriceps Tendon
Official Title
Number One Overall Graft Pick? Hamstring vs Bone-Patellar-Tendon-Bone vs Quadriceps Tendon: A Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 11, 2018 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Panam Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture
Keywords
Graft choice, hamstring, quadriceps tendon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective quasi-randomized clinical trial
Masking
Outcomes Assessor
Masking Description
The clinical assessments will be done by someone blinded to the arm of the study the patient is in.
Allocation
Non-Randomized
Enrollment
297 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quads tendon
Arm Type
Active Comparator
Arm Description
The graft tissue will be quadriceps tendon
Arm Title
Hamstring
Arm Type
Active Comparator
Arm Description
Semitendinosus and gracilis will be used for graft
Arm Title
BPTB
Arm Type
Active Comparator
Arm Description
Bone patellar tendon bone graft to be used.
Intervention Type
Procedure
Intervention Name(s)
ACL reconstruction - graft choice
Intervention Description
Use of 3 different ipsilateral autograft options
Primary Outcome Measure Information:
Title
graft re-injury (re-rupture, partial tear) or graft failure
Description
) 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
Time Frame
24 months
Secondary Outcome Measure Information:
Title
SANE
Time Frame
24 months
Title
Knee laxity
Description
KT1000 Knee Laxity Arthrometer
Time Frame
24 months
Title
Concentric maximal strength
Description
Knee flexion and extension strength - biodex
Time Frame
24 months
Title
Pain log
Description
type and quantity of pain medication use
Time Frame
3 weeks post operative
Title
ACL-QOL
Time Frame
24 months
Title
SF-12
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Pan Am Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M3E4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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