Number One Overall Graft Pick? Hamstring vs Bone-Patellar-Tendon-Bone vs Quadriceps Tendon
NCT ID: NCT03671421
Last Updated: 2024-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
297 participants
INTERVENTIONAL
2018-09-11
2024-11-30
Brief Summary
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Detailed Description
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Quasi-randomized clinical trial
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Quads tendon
The graft tissue will be quadriceps tendon
ACL reconstruction - graft choice
Use of 3 different ipsilateral autograft options
Hamstring
Semitendinosus and gracilis will be used for graft
ACL reconstruction - graft choice
Use of 3 different ipsilateral autograft options
BPTB
Bone patellar tendon bone graft to be used.
ACL reconstruction - graft choice
Use of 3 different ipsilateral autograft options
Interventions
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ACL reconstruction - graft choice
Use of 3 different ipsilateral autograft options
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
14 Years
50 Years
ALL
No
Sponsors
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Panam Clinic
OTHER
Responsible Party
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Peter MacDonald
Department head, orthopaedic surgery
Locations
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Pan Am Clinic
Winnipeg, Manitoba, Canada
Countries
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Other Identifiers
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B2016:066
Identifier Type: -
Identifier Source: org_study_id
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