ACTIVE_NOT_RECRUITING

STABILITY 2: Anterior Cruciate Ligament Reconstruction +/- Lateral Tenodesis With Patellar vs Quad Tendon

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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)

Quick Facts

Study Start:2020-07-28
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03935750

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 14-25,
  2. * An ACL-deficient knee,
  3. * Skeletal maturity (i.e. closed epiphyseal growth plates on standard knee radiographs),
  4. * 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.
  1. * Previous ACLR on either knee,
  2. * Partial ACL injury (defined as one bundle ACL tear requiring reconstruction/augmentation of the torn bundle with no surgery required for the intact bundle),
  3. * Multiple ligament injury (two or more ligaments requiring surgery),
  4. * Symptomatic articular cartilage defect requiring treatment other than debridement,
  5. * \>3 degrees of asymmetric varus,
  6. * Inflammatory arthropathy,
  7. * Inability to provide consent,
  8. * Pregnancy at baseline.

Contacts and Locations

Principal Investigator

James J Irrgang, PT PhD FAPTA
PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Alan Getgood, MD FRCS
PRINCIPAL_INVESTIGATOR
Fowler Kennedy Sport Medicine Clinic, Western University, Department of Surgery
Volker Musahl, MD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Dianne M Bryant, PhD
PRINCIPAL_INVESTIGATOR
Western University, School of Physical Therapy & Department of Surgery

Study Locations (Sites)

Stanford University
Redwood City, California, 94063
United States
University of California, San Francisco
San Francisco, California, 94158
United States
Orlando Health Jewett Orthopedic Institute
Orlando, Florida, 32806
United States
Med Center Health
Bowling Green, Kentucky, 42101
United States
University of Kentucky
Lexington, Kentucky, 40504
United States
Ochsner Clinic Foundation
Baton Rouge, Louisiana, 70836
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
University of New Mexico
Albuquerque, New Mexico, 87131
United States
Hospital for Special Surgery
New York, New York, 10021
United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27101
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
United States
The Rector and Visitors of the University of Virginia
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • James J Irrgang, PT PhD FAPTA, PRINCIPAL_INVESTIGATOR, University of Pittsburgh
  • Alan Getgood, MD FRCS, PRINCIPAL_INVESTIGATOR, Fowler Kennedy Sport Medicine Clinic, Western University, Department of Surgery
  • Volker Musahl, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh
  • Dianne M Bryant, PhD, PRINCIPAL_INVESTIGATOR, Western University, School of Physical Therapy & Department of Surgery

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-28
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2020-07-28
Study Completion Date2026-02-28

Terms related to this study

Keywords Provided by Researchers

  • Lateral extra-articular tenodesis
  • Autografting
  • Allografting
  • Bone-Patellar Tendon-Bone Grafting

Additional Relevant MeSH Terms

  • Anterior Cruciate Ligament Injury
  • Anterior Cruciate Ligament Reconstruction
  • Joint Instability