BIOSURE™ RG Knee Safety & Performance Study

Smith & Nephew

Status: Completed

Conditions: Knee Repair; Iliotibial Band Tenodesis; Lateral Collateral Ligament (LCL); Posterior Cruciate Ligament (PCL) Repair; Vastus Medialis Obliquus Advancement; Patellar Realignment and Tendon Repairs; Posterior Oblique Ligament (POL); Medial Collateral Ligament (MCL); Extra-capsular Repairs; ACL Repair

Study type: Observational

Funder types: Industry

Identifiers

NCT03519555

16-5010-16

Details and patient eligibility

About

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

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject has provided informed consent for study participation.

2. Subject is eighteen (18) years of age or older at the time of enrollment in the study.

3. 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

4. Subject is willing and able to comply with study visit schedule and to complete study procedures and questionnaires.

Exclusion criteria

1. Subject has Body Mass Index (BMI) > 40.
2. Subject has had total knee arthroplasty (TKA) in the study knee.
3. 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).
4. Subject has a known allergy to the study device or any of its components.
5. 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.
6. Subject is entered in another investigational drug, biologic, or device study, or has been treated with an investigational product in the past 30 days.
7. Subject is known to be at risk for loss to follow-up or failure to return for scheduled visits.