BIOSURE™ RG Knee Safety & Performance Study

Completed

Conditions studied: 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

In brief

Safety and Performance of the BIOSURE™ REGENESORB Interference Screw in Knee Ligament Repair and Reconstruction

Key facts

Study ID

NCT03519555

Run by

Smith & Nephew, Inc.

People needed

60

Starts

2017-11-09

Expected to finish

2020-10-05

Last updated by the study team

2021-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has provided informed consent for study participation.
• Subject is eighteen (18) years of age or older at the time of enrollment in the study.
• Subject requires one of the following knee procedures:
• Anterior cruciate ligament (ACL) repair
• Posterior cruciate ligament (PCL) repair
• Extra-capsular repair - Medial collateral ligament (MCL), Lateral collateral ligament (LCL), Posterior oblique ligament (POL)
• Patellar realignment and tendon repair Vastus medialis obliquus advancement Iliotibial band tenodesis
• Subject is willing and able to comply with study visit schedule and to complete study procedures and questionnaires.

You may not qualify if…

• Subject has Body Mass Index (BMI) > 40.
• Subject has had total knee arthroplasty (TKA) in the study knee.
• Subject has conditions that may interfere with graft survival or outcome (e.g. Paget disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).
• Subject has a known allergy to the study device or any of its components.
• Subject, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their willingness to participate in the study, including mental illness, mental retardation, drug or alcohol abuse, subject is pregnant, or plans to become pregnant during the study.
• Subject is entered in another investigational drug, biologic, or device study, or has been treated with an investigational product in the past 30 days.
• Subject is known to be at risk for loss to follow-up or failure to return for scheduled visits.

Where it is running

• OrthoIllinois — Rockford, Illinois, United States
• OrthoCarolina Research Institute, Inc. — Charlotte, North Carolina, United States
• Kelsey-Seybold Clinic/ Kelsey Research Foundation — Houston, Texas, United States

Full record on ClinicalTrials.gov

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