Long-term Follow up of the Stability 1 Trial
Launched by WESTERN UNIVERSITY, CANADA · Mar 13, 2025
Trial Information
Current as of September 30, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This study is a long-term follow-up of the Stability 1 trial. It looks at whether adding a small outside-the-knee stabilization procedure (called a lateral extra-articular tenodesis, LET) to ACL reconstruction helps prevent knee instability and graft rupture, and how it might affect knee health over 10 years, including the development of osteoarthritis. The study will use imaging and many patient-reported questionnaires to measure outcomes like knee pain, function, activity, and quality of life, with MRI for a subset of participants at the lead site.
Who can participate (in simple terms): people aged 14 to 25 who have an ACL-injured knee and are skeletally mature, plus at least two of these risk factors: playing competitive pivoting sports, having a noticeable pivot-shift test (grade 2 or higher), or having higher ligament laxity (Beighton score of 4 or more). People who have had ACL surgery on either knee before, severe multi-ligament injuries, certain cartilage problems, or a noticeable knee alignment deformity are not eligible. Participants will be randomly assigned to one of two surgical groups—standard ACL reconstruction or ACL reconstruction with LET—and will be followed at multiple centers in Canada and the UK for up to 10 years to track safety, knee function, activity level, and any signs of osteoarthritis. The study is led by Western University in Canada and funded with collaborators including CIHR.
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • ACL deficient knee
- • skeletally mature to 25 years of age
- * 2 or more of:
- • competitive pivoting sport
- • grade 2 pivot shift or greater
- • generalized ligament laxity - Beighton score of 4 or greater
- Exclusion criteria:
- • previous ACL reconstruction on either knee
- • multi-ligament injury (two or more ligaments requiring surgical attention)
- • symptomatic articular cartilage defect requiring treatment other than debridement
- • greater than 3 degrees of asymmetric varus
- • unable to complete outcome questionnaires
About Western University, Canada
Western University, located in Canada, is a leading research institution committed to advancing healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university harnesses the expertise of its faculty and research teams to conduct high-quality studies that address pressing medical challenges. Western University is dedicated to fostering a culture of ethical research practices, ensuring participant safety, and generating impactful findings that contribute to evidence-based medicine and improve patient outcomes. Through its robust infrastructure and commitment to excellence, Western University plays a vital role in the field of clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Calgary, Alberta, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Winnipeg, Manitoba, Canada
Banff, Alberta, Canada
Coventry, United Kingdom
New Westminster, British Columbia, Canada
Kingston, Ontario, Canada
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported