BIOSURE™ RG Knee Safety & Performance Study | NCT03519555

Studies
BIOSURE™ RG Knee Safety & Performance Study

NCT03519555

Sponsor

Smith & Nephew, Inc.

Status

Completed

Last Update Posted

Jul 8, 2021Actual

Enrollment

60Actual

Phase

Not provided

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

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 9, 2017Actual

Primary Completion Date

Oct 5, 2020Actual

Completion Date

Oct 5, 2020Actual

First Submitted Date

Jan 15, 2018

First Submission Date that Met QC Criteria

Apr 25, 2018

First Posted Date

May 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2021

Last Update Posted Date

Jul 8, 2021Actual

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
OrthoIllinois		Rockford	Illinois	61107	United States
OrthoCarolina Research Institute, Inc.