Anterior Cruciate Ligament Reconstruction Clinical Trial
— STABILITY 2Official title:
Anterior Cruciate Ligament Reconstruction Using Bone Patellar Bone or Quad Tendon Autograft With or Without Lateral Extra-Articular Tenodesis in Individuals Who Are at High Risk of Graft Failure (STABILITY 2)
Anterior cruciate ligament (ACL) rupture is one of the most common musculoskeletal injuries in young individuals, particularly those that are active in sports. Up to 30% of individuals under the age of 20 years suffer a re-injury to the reconstructed ACL. Revision ACLR has been associated with degeneration of the articular cartilage and increased rates of meniscal tears, increasing the risk of post-traumatic osteoarthritis (PTOA), additional surgical procedures, reduced physical function and quality of life. As such, strategies to reduce ACLR failure, particularly in young active individuals, are critical to improving short and long-term outcomes after ACL rupture. There is ongoing debate about the optimal graft choice and reconstructive technique. Three autograft options are commonly used, including the bone-patellar-tendon-bone (BPTB), quadriceps tendon (QT) and hamstring tendon (HT). Additionally, a lateral extra-articular tenodesis (LET) may provide greater stability to the ACLR; however, its effect on failure rate is unclear and surgery-induced lateral compartment OA is a concern. To definitively inform the choice of autograft and the need for a LET, this multicenter, international randomized clinical trial will randomly assign 1236 young, active patients at high risk of re-injury to undergo ACLR using BPTB or QT autograft with our without LET.
Status | Recruiting |
Enrollment | 1236 |
Est. completion date | March 30, 2025 |
Est. primary completion date | March 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 25 Years |
Eligibility | Inclusion Criteria: - Age 14-25, - An ACL-deficient knee, - Skeletal maturity (i.e. closed epiphyseal growth plates on standard knee radiographs), - At least two of the following: participate in a competitive pivoting sport; have a pivot shift of grade 2 or greater; have generalized ligamentous laxity (Beighton score of =4) and/or genu recurvatum >10 degrees. Exclusion Criteria: - Previous ACLR on either knee, - Partial ACL injury (defined as one bundle ACL tear requiring reconstruction/augmentation of the torn bundle with no surgery required for the intact bundle), - Multiple ligament injury (two or more ligaments requiring surgery), - Symptomatic articular cartilage defect requiring treatment other than debridement, - >3 degrees of asymmetric varus, - Inflammatory arthropathy, - Inability to provide consent, - Pregnancy at baseline. |
Country | Name | City | State |
---|---|---|---|
Canada | Banff Sport Medicine Clinic | Banff | Alberta |
Canada | University of Calgary Sport Medicine Centre | Calgary | Alberta |
Canada | Nova Scotia Health Authority | Halifax | Nova Scotia |
Canada | McMaster University | Hamilton | Ontario |
Canada | Fowler Kennedy Sport Medicine Clinic | London | Ontario |
Canada | Fraser Health Authority | New Westminster | British Columbia |
Canada | University of Ottawa | Ottawa | Ontario |
Canada | St. Michael's Hospital | Toronto | Ontario |
Canada | Pan Am Clinic | Winnipeg | Manitoba |
Denmark | Aarhus University Hospital | Aarhus | |
Germany | Cologne-Merheim Medical Center, Klinik für Orthopädie, Unfallchirurgie und Sporttraumatologie | Cologne | |
Germany | University Klinik Münster | Münster | |
Ireland | Dublin City University / UPMC Sports Surgery Clinic | Dublin | Dublin 9 |
Norway | Oslo University Hospital | Oslo | |
Sweden | Stockholm South Hospital, Karolinska Institutet | Stockholm | |
United Kingdom | North Bristol Trust | Bristol | |
United Kingdom | University Hospitals Coventry and Warwickshire NHS Trust | Coventry | |
United States | University of New Mexico | Albuquerque | New Mexico |
United States | University of Michigan | Ann Arbor | Michigan |
United States | Ochsner Clinic Foundation | Baton Rouge | Louisiana |
United States | Med Center Health | Bowling Green | Kentucky |
United States | The Rector and Visitors of the University of Virginia | Charlottesville | Virginia |
United States | University of Kentucky | Lexington | Kentucky |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Hospital for Special Surgery | New York | New York |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Stanford University | Redwood City | California |
United States | Mayo Clinic | Rochester | Minnesota |
United States | University of California, San Francisco | San Francisco | California |
United States | Wake Forest University School of Medicine | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | Canadian Institutes of Health Research (CIHR), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Western Ontario, Canada |
United States, Canada, Denmark, Germany, Ireland, Norway, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ACL Clinical Failure | This is a composite endpoint defined as 1) graft rupture or, 2) persistent rotational laxity (asymmetrical positive pivot shift). | 24 months | |
Secondary | ACL-Quality of Life (QOL) Questionnaire | The ACL Quality of Life (QOL) Questionnaire is a patient-reported disease-specific measure of physical symptoms, occupational concerns, recreational activities, lifestyle, social and emotional aspects of ACL injury. Each item has a 0-100 mm visual analogue scale response option (0 represents extremely difficult and 100 not difficult at all). Score is calculated as the average of each item for a total average score out of 100%, where 100% represents the best possible score. | 24 months (at 1.5, 3, 6, 12 and 24 months) | |
Secondary | Knee injury and Osteoarthritis Outcome Score (KOOS) | The Knee injury and Osteoarthritic Outcome Score (KOOS) is a patient-reported knee-specific that consists of 42 items in 5 domains (pain, other symptoms, function of daily living, function in sports/recreation and knee-related quality of life). Each domain is scored by summing the responses of the items in the domain standardized to a score from 0 to 100 (worst to best). | 24 months (at 1.5, 3, 6, 12 and 24 months) | |
Secondary | International Knee Documentation Committee Subjective Knee Form (IKDC-SKF) | The IKDC-SKF is an 18-item questionnaire that assesses symptoms, function and sports activities. The score is calculated by summing the item responses and normalizing to a scale that ranges from 0 to 100 with 100 representing no symptoms or limitations with function and sports activities. | 24 months (at 1.5, 3, 6, 12 and 24 months) | |
Secondary | Marx Activity Rating Scale | The Marx Activity Rating Scale will be used to measure sports activity level. It is a 4-item scale that measures how often patients are able to perform different activities (e.g. running, cutting, decelerating, and pivoting) on a 5-point scale (0 to 4). Scores range from 0 to 16, and higher scores represent higher level of activity. | 24 months (at 1.5, 3, 6, 12 and 24 months) | |
Secondary | Side-to-side difference in knee range of motion | Bilateral passive knee extension and active-assisted knee flexion will be measured with a standard goniometer. The side-to-side difference in range of motion will be calculated and interpreted based on the IKDC guidelines (normal: side-to-side difference in knee extension < 3 degrees and side-to-side difference in knee flexion < 5 degrees; nearly normal or worse). | 24 months (at 1.5, 3, 6, 12 and 24 months) | |
Secondary | Isokinetic Quadriceps Strength | Bilateral quadriceps strength will be measured using a computerized isokinetic dynamometer (assessing maximal concentric torque at an angular velocity of 90°/s). The ratio of peak torque of the involved to non-involved knee will be calculated. | 6, 12 and 24 months | |
Secondary | Isokinetic Hamstring Strength | Bilateral hamstring strength will be measured using a computerized isokinetic dynamometer (assessing maximal concentric torque at an angular velocity of 90°/s) . The ratio of peak torque of the involved to non-involved knee will be calculated. | 6, 12 and 24 months | |
Secondary | Isometric Quadriceps Strength | Bilateral quadriceps strength will be measured using hand-held dynamometer (assessing isometric maximal contraction at 90° of knee flexion). The ratio of peak torque of the involved to non-involved knee will be calculated. | 6, 12 and 24 months | |
Secondary | Isometric Hamstring Strength | Bilateral hamstring strength will be measured using hand-held dynamometer (assessing isometric maximal contraction at 90° of knee flexion). The ratio of peak torque of the involved to non-involved knee will be calculated. | 6, 12 and 24 months | |
Secondary | Limb Symmetry Index - Hop test | Calculated based on the average of four hop tests (single leg hop, 6m timed hop, triple hop, and triple crossover hop). For the single hop for distance, triple hop and triple crossover hop the limb symmetry index (LSI) will calculated as the ratio of the distance hopped on the ACL reconstructed lower extremity to the distance hopped contralateral lower extremity times 100%. For the 6m timed hop, the LSI will be calculated as the ratio of the time to hop 6m on the contralateral normal extremity to the time to hop 6 m on the ACL reconstructed extremity. For analysis, we will use the average of the LSIs for the four hop tests. | 6, 12 and 24 months | |
Secondary | Drop vertical jump (DVJ) testing | The drop vertical jump test will be quantified using a Microsoft Kinect V2 sensor and ACL Gold software to measure dynamic knee valgus that will be defined as the ratio of the distance between the knees to the distance between the ankles. The average ratio of the distance between the knees to ankles across 3 trials will be calculated and use for analysis. | 6 and 12 months | |
Secondary | Donor site morbidity - Sensory Disturbance | Sensory disturbance will be assessed via light touch to regions around the graft skin incision and anterolateral tibia. It will be rated as absent, mild, moderate or severe. This outcome will be presented as the proportion of individuals in each category. | 24 months (at 1.5, 3, 6, 12 and 24 months) | |
Secondary | Donor site morbidity - Anterior Kneeling Pain | Anterior kneeling pain measured using an 11-point numeric rating scale (0 - no pain; 10 - worst imaginable). | 24 months (at 1.5, 3, 6, 12 and 24 months) | |
Secondary | Adverse events | Defined as any new event not present during the pre-intervention period or an event present pre-intervention that has increased in severity. | 24 months (at 1.5, 3, 6, 12 and 24 months) |
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