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Search / Trial NCT03935750

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

Launched by UNIVERSITY OF PITTSBURGH · Apr 29, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Lateral Extra Articular Tenodesis Autografting Allografting Bone Patellar Tendon Bone Grafting

ClinConnect Summary

The STABILITY 2 trial is studying the best ways to perform surgery for young people who have torn their anterior cruciate ligament (ACL), a common injury in athletes. The trial will compare two types of surgical grafts—bone-patellar-tendon-bone (BPTB) and quadriceps tendon (QT)—and whether adding an extra procedure called lateral tenodesis (LET) can help prevent re-injury. The goal is to find the most effective approach to improve recovery and reduce the risk of future knee problems in active patients aged 14 to 25.

To participate in this trial, individuals need to be between 14 and 25 years old, have a knee injury where the ACL is torn, and be physically active in sports that involve quick movements. They should also have specific knee conditions that indicate a higher risk of re-injury. Participants will randomly be assigned to one of the surgery options and will be closely monitored throughout their recovery. This study is important because it aims to improve long-term outcomes for young athletes who are at risk of re-injuring their knees after surgery.

Gender

ALL

Eligibility criteria

  • 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.

About University Of Pittsburgh

The University of Pittsburgh is a leading research institution known for its commitment to advancing medical science and improving patient care through innovative clinical trials. With a robust infrastructure for research and a multidisciplinary approach, the university fosters collaboration among experts in various fields, facilitating the development of novel therapies and interventions. Its clinical trial programs emphasize ethical standards, patient safety, and the integration of cutting-edge technology, making the University of Pittsburgh a pivotal contributor to the landscape of clinical research and a trusted partner in the pursuit of health advancements.

Locations

Rochester, Minnesota, United States

Ann Arbor, Michigan, United States

Minneapolis, Minnesota, United States

New York, New York, United States

San Francisco, California, United States

Toronto, Ontario, Canada

Pittsburgh, Pennsylvania, United States

Minneapolis, Minnesota, United States

Albuquerque, New Mexico, United States

Calgary, Alberta, Canada

Hamilton, Ontario, Canada

London, Ontario, Canada

Aarhus, , Denmark

Winnipeg, Manitoba, Canada

Banff, Alberta, Canada

Aarhus, , Denmark

Coventry, , United Kingdom

Redwood City, California, United States

Ottawa, Ontario, Canada

Lexington, Kentucky, United States

Charlottesville, Virginia, United States

New Westminster, British Columbia, Canada

Oslo, , Norway

Winston Salem, North Carolina, United States

Halifax, Nova Scotia, Canada

Münster, , Germany

Stockholm, , Sweden

Baton Rouge, Louisiana, United States

Bowling Green, Kentucky, United States

Bristol, , United Kingdom

Bristol, , United Kingdom

Cologne, , Germany

Dublin, Dublin 9, Ireland

Orlando, Florida, United States

Dublin, , Ireland

Patients applied

0 patients applied

Trial Officials

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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