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Comparison of Three Methods for Anterior Cruciate Ligament Reconstruction

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ClinicalTrials.gov Identifier: NCT00529958
Recruitment Status : Active, not recruiting
First Posted : September 14, 2007
Results First Posted : February 20, 2019
Last Update Posted : May 19, 2021
Sponsor:
Collaborator:
Workers' Compensation Board, Alberta
Information provided by (Responsible Party):
Dr. Nicholas Mohtadi, University of Calgary

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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Rupture Deficiency of Anterior Cruciate Ligament Chronic Instability of Knee Anterior Cruciate Ligament Injury Procedure: Patellar Tendon Procedure: Hamstring Tendon Procedure: Double-Bundle Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : September 2007
Actual Primary Completion Date : December 2010
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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 Name: Double-bundle ST/G graft




Primary Outcome Measures :
  1. Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome [ Time Frame: Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures [ Time Frame: Minimum 2-year Follow-up, and 5-Year Follow-up ]
    • 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.

  2. Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade [ Time Frame: Baseline, 1, 2 and 5 years post-operatively ]
    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).

  3. Mean International Knee Documentation Committee (IKDC) Subjective Score [ Time Frame: Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively ]
    Patient-reported health-related outcome measure with a score between 0 and 100. A higher score represents a better outcome.

  4. Number of Participants With Each Pivot Shift Grade [ Time Frame: Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively ]

    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.


  5. Proportion of Patients With Moderate or Severe Kneeling Pain [ Time Frame: Baseline, 2 and 5 years post-operatively ]
    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.

  6. Knee Laxity as Measured by the KT Arthrometer [ Time Frame: Baseline, 1 and 2 years post-operatively ]
    Mean side-to-side differences, as measured using the KT-1000 Arthrometer instrument at 30lbs/134N forces to objectively measure knee laxity.

  7. Mean Tegner Activity Level [ Time Frame: Baseline, 6 months, 1 and 2 years post-operatively ]
    Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10))

  8. Return to Pre-injury Tegner Activity Level [ Time Frame: 1, 2 and 5 years post-operatively ]
    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)).

  9. Cincinnati Occupational Rating Scale [ Time Frame: Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively ]
    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.

  10. Skin-to-Skin Operative Times [ Time Frame: During surgery ]
    Skin-to-skin operative times (in minutes) for each ACL reconstruction procedure

  11. Radiographic (X-ray) Changes [ Time Frame: Baseline, 2 and 5 years post-operatively ]
    The analysis for the radiographic assessment data is currently ongoing, to provide a comparison of baseline, 2- and 5-year post-operative x-rays.


Other Outcome Measures:
  1. Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) [ Time Frame: 2 years post-operatively ]

    All complications/adverse events that occurred within the first two-years post-operatively.

    See Adverse Events section for results of this outcome.




Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00529958


Locations
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Canada, Alberta
University of Calgary Sport Medicine Centre
Calgary, Alberta, Canada, T2N 1N4
Sponsors and Collaborators
University of Calgary
Workers' Compensation Board, Alberta
Investigators
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Principal Investigator: Nicholas G Mohtadi, MD MSc FRCSC University of Calgary Sport Medicine Centre
Publications of Results:
Other Publications:
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Responsible Party: Dr. Nicholas Mohtadi, Clinical Professor and Orthopaedic Surgeon, University of Calgary
ClinicalTrials.gov Identifier: NCT00529958    
Other Study ID Numbers: REB15-1061 (formerly 20966)
First Posted: September 14, 2007    Key Record Dates
Results First Posted: February 20, 2019
Last Update Posted: May 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Nicholas Mohtadi, University of Calgary:
Anterior Cruciate Ligament (ACL) Reconstruction
Patellar Tendon
Hamstring Tendon
Double-Bundle
Autograft
Additional relevant MeSH terms:
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Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries