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Completed

NCT Number: NCT00529958

Comparison of Three Methods for Anterior Cruciate Ligament Reconstruction

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.

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Key information

Conditions

Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Injury Chronic Instability of Knee Deficiency of Anterior Cruciate Ligament Knee Injuries Leg Injuries Wounds and Injuries

Age range

14 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary Sport Medicine Centre

Calgary, Alberta, T2N 1N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patellar Tendon

Procedure

Patellar Tendon autograft

Other names: Bone-patellar tendon-bone graft, BTPB graft

Hamstring Tendon

Procedure

Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft

Other names: Single-bundle hamstring graft, ST/G graft

Double-Bundle

Procedure

Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft

Other names: Double-bundle ST/G graft

Primary outcomes

  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 outcomes

  1. Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures

    Time frame: Minimum 2-year Follow-up, 5-Year Follow-up, 10-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, 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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Workers' Compensation Board, Alberta

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2023
First posted
Sep 14, 2007
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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