Comparison of Three Methods for Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament Rupture Clinical Trial

Official title:

A Randomized Clinical Trial Comparing Three Methods for Anterior Cruciate Ligament Reconstruction: Patellar Tendon, Quadruple Semitendinosus/Gracilis and Double-Bundle Semitendinosus/Gracilis Grafts.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00529958
• Other study ID #: REB15-1061 (formerly 20966)
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2007
• Est. completion date: December 2021

Study information

• Verified date: April 2021
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 330
• Est. completion date: December 2021
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Patellar Tendon
Patellar Tendon autograft
• Hamstring Tendon
Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft
• Double-Bundle
Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft

Locations

Country	Name	City	State
Canada	University of Calgary Sport Medicine Centre	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Workers' Compensation Board, Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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. — View Citation

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 Ju — View Citation

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.0000000000 — View Citation

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. — View Citation

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;(9):CD005960. doi: 10.1002/14651858.CD005960.pub2. Review. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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, and 5-Year Follow-up
Secondary	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 and 5 years post-operatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Skin-to-Skin Operative Times	Skin-to-skin operative times (in minutes) for each ACL reconstruction procedure	During surgery
Secondary	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