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.

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.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Injury; Chronic Instability of Knee; Deficiency of Anterior Cruciate Ligament
• Intervention / Treatment: Procedure: Patellar Tendon; Procedure: Hamstring Tendon; Procedure: Double-Bundle

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • University of Calgary Sport Medicine Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patellar Tendon (PT); ACL reconstruction using a patellar tendon autograft	Procedure: Patellar Tendon; Patellar Tendon autograft; Other Names: Bone-patellar tendon-bone graft; BTPB graft
Active Comparator: Hamstring (HT); ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft	Procedure: Hamstring Tendon; Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft; Other Names: Single-bundle hamstring graft; ST/G graft
Active Comparator: Double-Bundle (DB); ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft	Procedure: Double-Bundle; Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft; Other Names: Double-bundle ST/G graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean International Knee Documentation Committee (IKDC) Subjective Score	Patient-reported health-related outcome measure with a score between 0 and 100. A higher score represents a better outcome.	Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively
Number of Participants With Each Pivot Shift Grade	The Pivot Shift test is a dynamic, passive test to assess the rotational instability of the Anterior Cruciate Ligament in the knee. Pivot shift grades include: equal/0 (negative); glide/1; clunk/2; gross/3. A positive grade indicates injury to the Anterior Cruciate Ligament.	Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively
Proportion of Patients With Moderate or Severe Kneeling Pain	Patients kneeled down on the same hard surface (i.e. clinic floor) and self-reported the pain on a scale of: none, mild, moderate or severe. The number of patients reporting moderate or severe kneeling pain were combined in the reported proportions.	Baseline, 2 and 5 years post-operatively
Knee Laxity as Measured by the KT Arthrometer	Mean side-to-side differences, as measured using the KT-1000 Arthrometer instrument at 30lbs/134N forces to objectively measure knee laxity.	Baseline, 1 and 2 years post-operatively
Mean Tegner Activity Level	Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10))	Baseline, 6 months, 1 and 2 years post-operatively
Return to Pre-injury Tegner Activity Level	Proportion of patients returning to pre-injury levels, as measured by the Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10)).	1, 2 and 5 years post-operatively
Cincinnati Occupational Rating Scale	The Cincinnati Occupational Rating Scale assesses the level of work-related activities, including sitting, standing, walking, squatting, climbing, lifting and carrying weighted objects. The score ranges from 0 to 100, with a lower score representing more sedentary work-related activities.	Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively
Skin-to-Skin Operative Times	Skin-to-skin operative times (in minutes) for each ACL reconstruction procedure	During surgery
Radiographic (X-ray) Changes	The analysis for the radiographic assessment data is currently ongoing, to provide a comparison of baseline, 2- and 5-year post-operative x-rays.	Baseline, 2 and 5 years post-operatively
Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures	COMPLETE TRAUMATIC RE-RUPTURE - defined as a consequence of an acute traumatic event resulting in a change in static stability since the most recent follow-up visit; determined clinically by a definite loss of end point on Lachman testing, increased anterior translation (>3mm) and a greater than or equal grade 2 pivot shift. Confirmed by MRI or diagnostic arthroscopy.; PARTIAL TRAUMATIC TEARS - defined as a consequence of an acute traumatic event resulting in a suspected meniscal injury or graft tear on history, without the clinical characteristics of a "complete traumatic rerupture". Confirmed by MR or diagnostic arthroscopy.; TRAUMATIC RE-INJURY - combined total of "complete traumatic re-ruptures" and "partial traumatic tears".; ATRAUMATIC GRAFT FAILURES - defined in the absence of an acute traumatic event, with greater than or equal grade 2 pivot shift and/or greater than or equal to 6mm side-to-side difference on the KT arthrometer.	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	IKDC Objective group grades: Normal (A), Nearly Normal (B), Abnormal (C), Severely Abnormal (D) The IKDC Objective Overall Group Grade is determined by the lowest grade assigned to defined objective knee examination measurements, including effusion, passive motion deficit and manual/instrumented ligament examinations (i.e. Lachman, anterior-posterior (AP) translation).	Baseline, 1, 2, 5 years post-operatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome)	All complications/adverse events that occurred within the first two-years post-operatively. See Adverse Events section for results of this outcome.	2 years post-operatively

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Workers' Compensation Board, Alberta
• Investigators: Principal Investigator: Nicholas G Mohtadi, MD MSc FRCSC, University of Calgary Sport Medicine Centre

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2007
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: September 12, 2007
• First Submitted That Met QC Criteria: September 12, 2007
• First Posted (Estimated): September 14, 2007

Study Record Updates

• Last Update Posted (Actual): December 11, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Autograft; Patellar Tendon; Anterior Cruciate Ligament (ACL) Reconstruction; Hamstring Tendon; Double-Bundle
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries; Rupture
• Other Study ID Numbers: REB15-1061 (formerly 20966)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO