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Anterior Cruciate Ligament RuptureNCT00529958

Comparison of Three Methods for Anterior Cruciate Ligament Reconstruction

A study testing Patellar Tendon, Hamstring Tendon and Double-Bundle in people with Anterior Cruciate Ligament Rupture and Deficiency of Anterior Cruciate Ligament, run by University of Calgary at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 14 to 50 yearsHealthy volunteers can take part
What is being tested?
Patellar Tendon, Hamstring Tendon and Double-Bundle
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
1 siteCanada
Study dates
Sep 2007to Sep 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Calgary Sport Medicine Centre

    Calgary, Alberta, T2N 1N4

Other trials in Canada

About this study

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.

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.

Read the 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.

Being tested
Patellar Tendon, Hamstring Tendon, Double-Bundle
Keywords
Anterior Cruciate Ligament (ACL) Reconstruction, Patellar Tendon, Hamstring Tendon, Double-Bundle, Autograft
Medical subject headings
Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patellar TendonProcedure or surgery

    Also called Bone-patellar tendon-bone graft, BTPB graft

    Patellar Tendon autograft

  • Hamstring TendonProcedure or surgery

    Also called Single-bundle hamstring graft, ST/G graft

    Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft

  • Double-BundleProcedure or surgery

    Also called Double-bundle ST/G graft

    Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft

Study groups in NCT00529958
Study groupRoleWhat they receive
Patellar Tendon (PT)Active comparatorACL reconstruction using a patellar tendon autograft
Receives: Procedure: Patellar Tendon
Hamstring (HT)Active comparatorACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft
Receives: Procedure: Hamstring Tendon
Double-Bundle (DB)Active comparatorACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft
Receives: Procedure: Double-Bundle

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 3 and 6 months, 1, 2, and 5 years post-operatively

Secondary outcomes (11)

  1. 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.

    Measured: Minimum 2-year Follow-up, 5-Year Follow-up, 10-Year Follow-up

  2. 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).

    Measured: Baseline, 1, 2, 5 years post-operatively

  3. 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.

    Measured: Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively

  4. 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.

    Measured: Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively

  5. 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.

    Measured: Baseline, 2 and 5 years post-operatively

  6. 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.

    Measured: Baseline, 1 and 2 years post-operatively

  7. Mean Tegner Activity Level

    Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10))

    Measured: Baseline, 6 months, 1 and 2 years post-operatively

  8. 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)).

    Measured: 1, 2 and 5 years post-operatively

  9. 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.

    Measured: Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively

  10. Skin-to-Skin Operative Times

    Skin-to-skin operative times (in minutes) for each ACL reconstruction procedure

    Measured: During surgery

  11. 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.

    Measured: Baseline, 2 and 5 years post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionDec 2010
  4. Study completionSep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
330 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00529958
Sponsor's protocol ID
REB15-1061 (formerly 20966)
Status last verified
Nov 2024
First submitted
12 Sep 2007
Last updated
11 Dec 2024
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 9617395

  • 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.

    PubMed 21901700

  • 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.

    PubMed 25881568

  • 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.

    PubMed 25514139

  • 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.

    PubMed 26164058

  • 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.

    PubMed 31169571

  • Mohtadi N, Chan D, Hunter D, Bertiche P, Marmura H, Bryant D. Quality-of-life outcomes and osteoarthritis development at 10 years after anterior cruciate ligament reconstruction: A large randomized clinical trial comparing patellar tendon, hamstring tendon, and double-bundle grafts. J ISAKOS. 2026 Sep 22;21:101220. doi: 10.1016/j.jisako.2026.101220. Online ahead of print.

    PubMed 42762953

Questions about this trial

What is this clinical trial studying?

A study testing Patellar Tendon, Hamstring Tendon and Double-Bundle in people with Anterior Cruciate Ligament Rupture and Deficiency of Anterior Cruciate Ligament, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome (time frame: Baseline, 3 and 6 months, 1, 2, and 5 years post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00529958, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.

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