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Comparison of Three Methods for Anterior Cruciate Ligament Reconstruction

NCT ID: NCT00529958

Last Updated: 2024-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2023-09-30

Brief Summary

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The purpose of this randomized clinical trial is to determine the difference in quality of life outcome at two years, in patients undergoing an Anterior Cruciate Ligament (ACL) reconstruction procedure with either a patellar tendon, quadruple hamstring tendon or a double-bundle hamstring tendon autograft.

Detailed Description

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Following an ACL injury, the knee is predisposed to chronic instability, further damage to the meniscal and chondral structures in the knee, osteoarthritis and an impaired quality of life. The successful treatment of an ACL deficient knee aims to preserve the intact meniscus and chondral structures, and to provide a functionally stable knee so that patients can return to pre-injury activities and restore their quality of life. The current standard of care for ACL deficient knees is with a surgical ACL reconstruction procedure. A Cochrane Review was done and demonstrated that the existing literature is controversial. To date, no existing trial has used validated patient-based outcome assessment, accounted for the critical differences between acute and chronic ACL deficiency or used modern techniques to ensure randomization concealment and a sufficient sample size to avoid type II error. The existing information does not define graft failure or re-ruptures, involve long-term follow-up to address osteoarthritis development, nor compare outcomes between single- and double-bundle reconstructive techniques. The current standard includes either a patellar tendon or quadruple semitendinosus/gracilis tendon autograft reconstruction. The newest option is a double-bundle semitendinosus/gracilis graft. This option attempts to restore the complex ACL anatomy by using two separate tendon components to reconstruct the ACL. This study will measure disease-specific quality of life at short- and long-term post-operative intervals (1, 2, 5 and 10 years). Additional secondary outcomes, including the incidence of traumatic re-ruptures and graft failures, will also be compared between treatment groups.

Conditions

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Anterior Cruciate Ligament Rupture Deficiency of Anterior Cruciate Ligament Chronic Instability of Knee Anterior Cruciate Ligament Injury

Keywords

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Anterior Cruciate Ligament (ACL) Reconstruction Patellar Tendon Hamstring Tendon Double-Bundle Autograft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Patellar Tendon (PT)

ACL reconstruction using a patellar tendon autograft

Group Type ACTIVE_COMPARATOR

Patellar Tendon

Intervention Type PROCEDURE

Patellar Tendon autograft

Hamstring (HT)

ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft

Group Type ACTIVE_COMPARATOR

Hamstring Tendon

Intervention Type PROCEDURE

Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft

Double-Bundle (DB)

ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft

Group Type ACTIVE_COMPARATOR

Double-Bundle

Intervention Type PROCEDURE

Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft

Interventions

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Patellar Tendon

Patellar Tendon autograft

Intervention Type PROCEDURE

Hamstring Tendon

Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft

Intervention Type PROCEDURE

Double-Bundle

Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft

Intervention Type PROCEDURE

Other Intervention Names

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Bone-patellar tendon-bone graft BTPB graft Single-bundle hamstring graft ST/G graft Double-bundle ST/G graft

Eligibility Criteria

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Inclusion Criteria

A confirmed diagnosis of anterior cruciate ligament deficiency based on all of the following:

* History of a traumatic injury episode
* Physical examination findings of increased anterior translation of the tibia on the femur (Lachman test and/or anterior drawer test)
* A positive pivot shift test
* X-rays showing skeletal maturity (ie: tibial tubercle fused) and no fractures. (NB: Magnetic resonance imaging is not required)
* Age 14-50 years old

Exclusion Criteria

* Patients with combined ligament deficiencies (Posterior Cruciate, Medial and/or Lateral Collateral deficiency.) (NB: Grade 1 side to side differences (ie. \< 5mm) on valgus, varus or posterior stress testing will not be considered exclusions)
* Intra-operative identification of International Cartilage Repair Society (ICRS) Grade 4 chondral lesion of \> 1 cm ² \[61\]
* Previous ligament surgery on the affected or contralateral knees
* Cases involving litigation or Worker's Compensation
* Confirmed connective tissue disorder (ie: Ehlers-Danlos, Marfans)
* X-ray showing that tibial physis is not fused
Minimum Eligible Age

14 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Workers' Compensation Board, Alberta

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Dr. Nicholas Mohtadi

Clinical Professor and Orthopaedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicholas G Mohtadi, MD MSc FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of Calgary Sport Medicine Centre

Locations

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University of Calgary Sport Medicine Centre

Calgary, Alberta, Canada

Site Status

Countries

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Canada

References

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Mohtadi N. Development and validation of the quality of life outcome measure (questionnaire) for chronic anterior cruciate ligament deficiency. Am J Sports Med. 1998 May-Jun;26(3):350-9. doi: 10.1177/03635465980260030201.

Reference Type BACKGROUND
PMID: 9617395 (View on PubMed)

Mohtadi NG, Chan DS, Dainty KN, Whelan DB. Patellar tendon versus hamstring tendon autograft for anterior cruciate ligament rupture in adults. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD005960. doi: 10.1002/14651858.CD005960.pub2.

Reference Type BACKGROUND
PMID: 21901700 (View on PubMed)

Mohtadi N, Barber R, Chan D, Paolucci EO. Complications and Adverse Events of a Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction. Clin J Sport Med. 2016 May;26(3):182-9. doi: 10.1097/JSM.0000000000000202.

Reference Type RESULT
PMID: 25881568 (View on PubMed)

Mohtadi N, Chan D, Barber R, Oddone Paolucci E. A Randomized Clinical Trial Comparing Patellar Tendon, Hamstring Tendon, and Double-Bundle ACL Reconstructions: Patient-Reported and Clinical Outcomes at a Minimal 2-Year Follow-up. Clin J Sport Med. 2015 Jul;25(4):321-31. doi: 10.1097/JSM.0000000000000165.

Reference Type RESULT
PMID: 25514139 (View on PubMed)

Mohtadi N, Chan D, Barber R, Paolucci EO. Reruptures, Reinjuries, and Revisions at a Minimum 2-Year Follow-up: A Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction. Clin J Sport Med. 2016 Mar;26(2):96-107. doi: 10.1097/JSM.0000000000000209.

Reference Type RESULT
PMID: 26164058 (View on PubMed)

Mohtadi NG, Chan DS. A Randomized Clinical Trial Comparing Patellar Tendon, Hamstring Tendon, and Double-Bundle ACL Reconstructions: Patient-Reported and Clinical Outcomes at 5-Year Follow-up. J Bone Joint Surg Am. 2019 Jun 5;101(11):949-960. doi: 10.2106/JBJS.18.01322.

Reference Type RESULT
PMID: 31169571 (View on PubMed)

Other Identifiers

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REB15-1061 (formerly 20966)

Identifier Type: -

Identifier Source: org_study_id