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NCT03935750 · ClinicalTrials.gov registry record · NA
STABILITY 2: Anterior Cruciate Ligament Reconstruction +/- Lateral Tenodesis With Patellar vs Quad Tendon
A NA study of Anterior Cruciate Ligament Reconstruction and Anterior Cruciate Ligament Injury, sponsored by University of Pittsburgh.
- Active
- Registry status
- NA
- Development phase
- 1,236
- Enrollment target
- 20
- Study locations
NCT03935750 is a NA study of Anterior Cruciate Ligament Reconstruction and Anterior Cruciate Ligament Injury that is active but no longer recruiting, run by University of Pittsburgh. The registered enrollment target is 1,236 participants, above the 182-participant average among 11 other Anterior Cruciate Ligament Reconstruction trials with a reported enrollment target (579% higher). The trial reports 20 study locations across 16 states.
The verdict
NCT03935750, a NA study of Anterior Cruciate Ligament Reconstruction and Anterior Cruciate Ligament Injury, is active but no longer recruiting, sponsored by University of Pittsburgh.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 1,236 participants
- Enrollment target
- 20
- Study locations
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?
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, categorized as NA. The registered enrollment target is 1,236 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 182-participant average among 11 other Anterior Cruciate Ligament Reconstruction trials with a reported enrollment target (579% higher). The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
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.
NCT03935750 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Kentucky, Minnesota.
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.
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).
Who is sponsoring clinical trial NCT03935750?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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.
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