ACL Repair, Extra-capsular Repairs, Iliotibial Band Tenodesis, Knee Repair, Lateral Collateral Ligament (LCL), Medial Collateral Ligament (MCL), Patellar Realignment and Tendon Repairs, Posterior Cruciate Ligament (PCL) Repair, Posterior Oblique Ligament (POL), Vastus Medialis Obliquus Advancement
Conditions
Brief 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
Interventions
None listed
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graft fixation survival | 6 months | Survival rate at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graft survival at 6 and 12 months | 6 months and 12 months | where failure is defined as graft repair failure for any reason |
| Quality of Life - International Knee Documentation Committee Score | Pre-Op, 6 months and 12 months | Patient Reported Outcomes using International Knee Documentation Committee Score. Scores summed and normalized to 100, minimum score is 0 points and maximum score is 100 points. The lower the score, the greater the disability. |
| Graft fixation survival | 12 months | Survival rate at 12 months |
| Quality of Life - Lysholm Score | Pre-Op, 6 months and 12 months | Patient Reported Outcomes using Lysholm Score, subject will answer eight questions on how knee pain has affected everyday life. Each question will be answered by placing a checkmark that best describes current condition. |
| Quality of Life - EQ-5D-5L | Pre-Op, 6 months and 12 months | Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire, subject will check box describing health on mobility, self-care, usual daily activities, pain/discomfort, and anxiety/depression. There are five checkbox options for each: no problems, slight, severe, unable to do activity. Subject will indicate from a scale of 1 to 100 (100 best), how good or bad is current health. |
| Quality of Life - Tegner Activity Scale | Pre-Op, 6 months and 12 months | Patient Reported Outcomes using Tegner Activity Scale, subject indicates highest level of activity before injury and highest level of activity after injury. Levels on a scale from 0 to 10, with 10 being highest level. |
Countries
United States
Outcome results
None listed