BIOSURE™ RG Knee Safety & Performance Study

Sponsor

Smith & Nephew, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03519555

Collaborator

(none)

Enrollment

Locations

34.9

Actual Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 9, 2017

Actual Primary Completion Date :

Oct 5, 2020

Actual Study Completion Date :

Oct 5, 2020

Outcome Measures

Primary Outcome Measures

Graft fixation survival [6 months]
Survival rate at 6 months

Secondary Outcome Measures

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
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 - 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OrthoIllinois	Rockford	Illinois	United States	61107
2	OrthoCarolina Research Institute, Inc.	Charlotte	North Carolina	United States	28207
3	Kelsey-Seybold Clinic/ Kelsey Research Foundation	Houston	Texas	United States	77025

Sponsors and Collaborators

Smith & Nephew, Inc.

Investigators

Study Chair: Stephan Mangin, Smith & Nephew, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Smith & Nephew, Inc.

ClinicalTrials.gov Identifier:

NCT03519555

Other Study ID Numbers:

16-5010-16

First Posted:

May 9, 2018

Last Update Posted:

Jul 8, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 8, 2021