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

NCT ID: NCT03671421

Last Updated: 2024-04-02

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

297 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-11

Study Completion Date

2024-11-30

Brief Summary

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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

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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

Conditions

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Anterior Cruciate Ligament Rupture

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Prospective quasi-randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The clinical assessments will be done by someone blinded to the arm of the study the patient is in.

Study Groups

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Quads tendon

The graft tissue will be quadriceps tendon

Group Type ACTIVE_COMPARATOR

ACL reconstruction - graft choice

Intervention Type PROCEDURE

Use of 3 different ipsilateral autograft options

Hamstring

Semitendinosus and gracilis will be used for graft

Group Type ACTIVE_COMPARATOR

ACL reconstruction - graft choice

Intervention Type PROCEDURE

Use of 3 different ipsilateral autograft options

BPTB

Bone patellar tendon bone graft to be used.

Group Type ACTIVE_COMPARATOR

ACL reconstruction - graft choice

Intervention Type PROCEDURE

Use of 3 different ipsilateral autograft options

Interventions

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ACL reconstruction - graft choice

Use of 3 different ipsilateral autograft options

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

14 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Panam Clinic

OTHER

Sponsor Role lead

Responsible Party

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Peter MacDonald

Department head, orthopaedic surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pan Am Clinic

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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B2016:066

Identifier Type: -

Identifier Source: org_study_id

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