BIOSURE™ RG Knee Safety & Performance Study

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

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

Study Overview

• Status: Completed
• 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

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Rockford, Illinois, United States, 61107
      • OrthoIllinois
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina Research Institute, Inc.
  • Texas
    • Houston, Texas, United States, 77025
      • Kelsey-Seybold Clinic/ Kelsey Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All subjects who have received BIOSURE™ REGENESORB Interference Screw in Knee Ligament Repair and Reconstruction. This population will be used for safety analysis.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft fixation survival	Survival rate at 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft fixation survival	Survival rate at 12 months	12 months
Graft survival at 6 and 12 months	where failure is defined as graft repair failure for any reason	6 months and 12 months
Quality of Life - International Knee Documentation Committee Score	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.	Pre-Op, 6 months and 12 months
Quality of Life - Tegner Activity Scale	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.	Pre-Op, 6 months and 12 months
Quality of Life - Lysholm Score	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.	Pre-Op, 6 months and 12 months
Quality of Life - EQ-5D-5L	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.	Pre-Op, 6 months and 12 months

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2017
• Primary Completion (Actual): October 5, 2020
• Study Completion (Actual): October 5, 2020

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: April 25, 2018
• First Posted (Actual): May 9, 2018

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 16-5010-16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No