CompletedNot Applicable

BIOSURE™ RG Knee Safety & Performance Study

United States60 participantsStarted 2017-11-09

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. Subject is willing and able to comply with study visit schedule and to complete study procedures and questionnaires.

✕. 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.

Graft fixation survival

Timeframe: 6 months

NCT IDNCT03519555

SponsorSmith & Nephew, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-10-05

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. Subject is willing and able to comply with study visit schedule and to complete study procedures and questionnaires.

✕. 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.