BIOSURE™ RG Knee Safety & Performance Study

Completed

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

• Registration Number: NCT03519555
• Lead Sponsor: Smith & Nephew, Inc.

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

Study Timeline

• Study Start: 2017-11-09
• Study First Submitted: 2018-01-15
• Study First Submitted QC: 2018-04-25
• Study First Posted: 2018-05-09
• Primary Completion: 2020-10-05
• Study Completion: 2020-10-05
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-07
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Graft fixation survival	6 months	Survival rate at 6 months

Secondary Outcome Measures

Name	Time	Method
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.
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.
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 - 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.
Graft fixation survival	12 months	Survival rate at 12 months
Graft survival at 6 and 12 months	6 months and 12 months	where failure is defined as graft repair failure for any reason

Trial Locations

Locations (3)

OrthoIllinois; 🇺🇸 Rockford, Illinois, United States

OrthoCarolina Research Institute, Inc.; 🇺🇸 Charlotte, North Carolina, United States

Kelsey-Seybold Clinic/ Kelsey Research Foundation; 🇺🇸 Houston, Texas, United States