Trials / Completed
CompletedNCT03519555
BIOSURE™ RG Knee Safety & Performance Study
Safety and Performance of the BIOSURE™ REGENESORB Interference Screw in Knee Ligament Repair and Reconstruction
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (actual)
- Sponsor
- Smith & Nephew, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Safety and Performance of the BIOSURE™ REGENESORB Interference Screw in Knee Ligament Repair and Reconstruction
Detailed description
This post-market clinical follow-up (PMCF) study will prospectively evaluate the short-term (6- and 12-month) safety and performance of the BIOSURE REGENESORB Interference Screw when used for any of the following: Knee repair: * ACL repair Posterior cruciate ligament (PCL) repair * Extra-capsular repairs * Medial collateral ligament (MCL) * Lateral collateral ligament (LCL) * Posterior oblique ligament (POL) * Patellar realignment and tendon repairs * Vastus medialis obliquus advancement * Iliotibial band tenodesis
Conditions
- ACL Repair
- Posterior Cruciate Ligament (PCL) Repair
- Medial Collateral Ligament (MCL)
- Lateral Collateral Ligament (LCL)
- Posterior Oblique Ligament (POL)
- Patellar Realignment and Tendon Repairs
- Vastus Medialis Obliquus Advancement
- Iliotibial Band Tenodesis
- Extra-capsular Repairs
- Knee Repair
Timeline
- Start date
- 2017-11-09
- Primary completion
- 2020-10-05
- Completion
- 2020-10-05
- First posted
- 2018-05-09
- Last updated
- 2021-07-08
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03519555. Inclusion in this directory is not an endorsement.