Clinical trial NCT03519555: BIOSURE™ RG Knee Safety & Performance Study
Official title: Safety and Performance of the BIOSURE™ REGENESORB Interference Screw in Knee Ligament Repair and Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Graft fixation survival
timeFrame: 6 months
Secondary outcomes:
measure: Graft fixation survival
timeFrame: 12 months
measure: Graft survival at 6 and 12 months
timeFrame: 6 months and 12 months
measure: Quality of Life - International Knee Documentation Committee Score
timeFrame: Pre-Op, 6 months and 12 months
measure: Quality of Life - Tegner Activity Scale
timeFrame: Pre-Op, 6 months and 12 months
measure: Quality of Life - Lysholm Score
timeFrame: Pre-Op, 6 months and 12 months
measure: Quality of Life - EQ-5D-5L
timeFrame: Pre-Op, 6 months and 12 months
Other outcomes:
Locations:
city: Rockford
country: United States
facility: OrthoIllinois
state: Illinois
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute, Inc.
state: North Carolina
city: Houston
country: United States
facility: Kelsey-Seybold Clinic/ Kelsey Research Foundation
state: Texas
Study officials:
affiliation: Smith & Nephew, Inc.
name: Stephan Mangin
role: STUDY_CHAIR
References: