BIOSURE™ RG Knee Safety & Performance Study

July 7, 2021 updated by: Smith & Nephew, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Graft fixation survival
Time Frame: 6 months
Survival rate at 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Graft fixation survival
Time Frame: 12 months
Survival rate at 12 months
12 months
Graft survival at 6 and 12 months
Time Frame: 6 months 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
Time Frame: 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.
Pre-Op, 6 months and 12 months
Quality of Life - Tegner Activity Scale
Time Frame: 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.
Pre-Op, 6 months and 12 months
Quality of Life - Lysholm Score
Time Frame: 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.
Pre-Op, 6 months and 12 months
Quality of Life - EQ-5D-5L
Time Frame: 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.
Pre-Op, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Smith & Nephew, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 5, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 5, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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