Comparison of Three Methods for Anterior Cruciate Ligament Reconstruction
A Randomized Clinical Trial Comparing Three Methods for Anterior Cruciate Ligament Reconstruction: Patellar Tendon, Quadruple Semitendinosus/Gracilis and Double-Bundle Semitendinosus/Gracilis Grafts.
1 other identifier
interventional
330
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 12, 2007
CompletedFirst Posted
Study publicly available on registry
September 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedResults Posted
Study results publicly available
February 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedDecember 11, 2024
November 1, 2024
3.3 years
September 12, 2007
November 7, 2017
November 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome
The 32-item patient-reported Anterior Cruciate Ligament Quality-of-Life (ACL-QOL) questionnaire assesses symptoms/physical complaints, work-related, sports/recreational, lifestyle and social/emotional concerns. A higher score on the 0 to 100mm visual analog scale represents better quality of life.
Baseline, 3 and 6 months, 1, 2, and 5 years post-operatively
Secondary Outcomes (11)
Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures
Minimum 2-year Follow-up, 5-Year Follow-up, 10-Year Follow-up
Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade
Baseline, 1, 2, 5 years post-operatively
Mean International Knee Documentation Committee (IKDC) Subjective Score
Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively
Number of Participants With Each Pivot Shift Grade
Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively
Proportion of Patients With Moderate or Severe Kneeling Pain
Baseline, 2 and 5 years post-operatively
- +6 more secondary outcomes
Other Outcomes (1)
Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome)
2 years post-operatively
Study Arms (3)
Patellar Tendon (PT)
ACTIVE COMPARATORACL reconstruction using a patellar tendon autograft
Hamstring (HT)
ACTIVE COMPARATORACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft
Double-Bundle (DB)
ACTIVE COMPARATORACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft
Interventions
Patellar Tendon autograft
Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- Workers' Compensation Board, Albertacollaborator
Study Sites (1)
University of Calgary Sport Medicine Centre
Calgary, Alberta, T2N 1N4, Canada
Related Publications (6)
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.
PMID: 9617395BACKGROUNDMohtadi 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.
PMID: 21901700BACKGROUNDMohtadi 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.
PMID: 25881568RESULTMohtadi 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.
PMID: 25514139RESULTMohtadi 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.
PMID: 26164058RESULTMohtadi 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.
PMID: 31169571RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- ACL RCT Research Coordinator
- Organization
- University of Calgary Sport Medicine Centre
Study Officials
- PRINCIPAL INVESTIGATOR
Nicholas G Mohtadi, MD MSc FRCSC
University of Calgary Sport Medicine Centre
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor and Orthopaedic Surgeon
Study Record Dates
First Submitted
September 12, 2007
First Posted
September 14, 2007
Study Start
September 1, 2007
Primary Completion
December 1, 2010
Study Completion
September 1, 2023
Last Updated
December 11, 2024
Results First Posted
February 20, 2019
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share