BIOSURE™ RG Knee Safety & Performance Study

NCT03519555 | Completed

• 1 other identifier: 16-5010-16
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• Graft fixation survival

  Survival rate at 6 months

  6 months

Secondary Outcomes (6)

• Graft fixation survival

  12 months

• Graft survival at 6 and 12 months

  6 months and 12 months

• Quality of Life - International Knee Documentation Committee Score

  Pre-Op, 6 months and 12 months

• Quality of Life - Tegner Activity Scale

  Pre-Op, 6 months and 12 months

• Quality of Life - Lysholm Score

  Pre-Op, 6 months and 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (3)

OrthoIllinois

Rockford, Illinois, 61107, United States

Location

OrthoCarolina Research Institute, Inc.

Charlotte, North Carolina, 28207, United States

Location

Kelsey-Seybold Clinic/ Kelsey Research Foundation

Houston, Texas, 77025, United States

Location

Study Officials

• Stephan Mangin

  Smith & Nephew, Inc.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: May 9, 2018
• Study Start: November 9, 2017
• Primary Completion: October 5, 2020
• Study Completion: October 5, 2020
• Last Updated: July 8, 2021

Record last verified: 2021-07

Locations

US (3)