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

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.

Conditions

Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Reconstruction, Joint Instability

Study Overview

Study Details

Study overview

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.

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)

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

Condition
Anterior Cruciate Ligament Injury
Intervention / Treatment

-

Contacts and Locations

Redwood City

Stanford University, Redwood City, California, United States, 94063

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94158

Bowling Green

Med Center Health, Bowling Green, Kentucky, United States, 42101

Lexington

University of Kentucky, Lexington, Kentucky, United States, 40504

Baton Rouge

Ochsner Clinic Foundation, Baton Rouge, Louisiana, United States, 70836

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55455

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Albuquerque

University of New Mexico, Albuquerque, New Mexico, United States, 87131

New York

Hospital for Special Surgery, New York, New York, United States, 10021

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

14 Years to 25 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2025-03-30