Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
STABILITY 2: Anterior Cruciate Ligament Reconstruction +/- Lateral Tenodesis With Patellar vs Quad Tendon
NCT03935750 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- PROCEDURE Anterior cruciate ligament reconstruction (ACLR)
- PROCEDURE Lateral extra-articular tenodesis (LET)
Study Locations (20)
California
- Stanford University — Redwood City
- University of California, San Francisco — San Francisco
Kentucky
- Med Center Health — Bowling Green
- University of Kentucky — Lexington
Minnesota
- University of Minnesota — Minneapolis
- Mayo Clinic — Rochester
Alberta
- Banff Sport Medicine Clinic — Banff
- University of Calgary Sport Medicine Centre — Calgary
Florida
- Orlando Health Jewett Orthopedic Institute — Orlando
Louisiana
- Ochsner Clinic Foundation — Baton Rouge
Michigan
- University of Michigan — Ann Arbor
New Mexico
- University of New Mexico — Albuquerque
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,236 participants |
| Start Date | 2020-07-28 |
| Est. Completion | 2026-02-28 |
| Phase | NA |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03935750
The ClinicalTrials.gov registry entry for NCT03935750 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,236 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,082 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Anterior Cruciate Ligament Reconstruction appearing as the primary indexed condition, and to 2 interventions — of which Anterior cruciate ligament reconstruction (ACLR) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03935750 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, Kentucky, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03935750 about?
NCT03935750 is a clinical study titled "STABILITY 2: Anterior Cruciate Ligament Reconstruction +/- Lateral Tenodesis With Patellar vs Quad Tendon". 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 degen...
What is the current status of trial NCT03935750?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,236 participants. The study started on 2020-07-28. Estimated completion is 2026-02-28.
What conditions does trial NCT03935750 study?
This clinical trial studies the following conditions: Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injury, Joint Instability. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03935750?
The interventions under investigation include: Anterior cruciate ligament reconstruction (ACLR) (PROCEDURE), Lateral extra-articular tenodesis (LET) (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03935750?
This trial is sponsored by University of Pittsburgh, which has 1,082 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03935750 being conducted?
This trial has 20 study locations across California, Florida, Kentucky, Louisiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.