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Completed

NCT Number: NCT03519555

BIOSURE™ RG Knee Safety & Performance Study

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

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Key information

Conditions

ACL Repair Extra-capsular Repairs Iliotibial Band Tenodesis Knee Repair Lateral Collateral Ligament (LCL) Medial Collateral Ligament (MCL) Patellar Realignment and Tendon Repairs Posterior Cruciate Ligament (PCL) Repair Posterior Oblique Ligament (POL) Vastus Medialis Obliquus Advancement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OrthoIllinois, Rockford, Illinois, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Graft fixation survival

    Time frame: 6 months

    Survival rate at 6 months

Secondary outcomes

  1. Graft fixation survival

    Time frame: 12 months

    Survival rate at 12 months

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 9, 2018
Registry last updated
Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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