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COMPLETED
NCT03985839

Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and Hip

Sponsor: Smith & Nephew, Inc.

View on ClinicalTrials.gov

Summary

This is a prospective, multi-center, PMCF study to evaluate the safety and performance of the MICRORAPTOR REGENESORB suture anchors, MICRORAPTOR Knotless REGENESORB suture anchors, and MICRORAPTOR Knotless PEEK suture anchors implanted in 315 subjects needing reattachment of soft tissue to bone.

Official title: Prospective Multi-Center Post-Market Clinical Follow-up Study to Evaluate Safety and Performance of the MICRORAPTOR REGENESORB, Knotless REGENESORB and Knotless PEEK Suture Anchors (and MINITAPE Sutures) in Shoulder and Hip Arthroscopic Instability Repair

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

OBSERVATIONAL

Enrollment

298

Start Date

2019-08-01

Completion Date

2024-08-08

Last Updated

2026-07-13

Healthy Volunteers

No

Interventions

DEVICE

MICRORAPTOR™ REGENESORB™ Suture Anchor

Smith \& Nephew MICRORAPTOR™ REGENESORB™ Suture Anchor is a fixation device intended to provide secure attachment of soft tissue to bone.

DEVICE

MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor

MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor is fixation device, which consists of an anchor on an inserter, and a suture threader. The anchor consists of the following components: a proximal anchor body (REGENESORB™), and a non-absorbable PEEK (Polyether ether ketone) distal anchor tip.

DEVICE

MICRORAPTOR™ Knotless PEEK Suture Anchor

The MICRORAPTOR™ Knotless PEEK Suture Anchor is a class IIb device, which consists of an anchor on an inserter, and a suture threader. The anchor consists of the following components: a proximal anchor body (PEEK), and a non-absorbable PEEK distal anchor tip.

Locations (12)

University of Colorado

Aurora, Colorado, United States

Colorado Springs Orthopaedic Group

Colorado Springs, Colorado, United States

Holy Cross Orthopedic Institute

Oakland Park, Florida, United States

Emory University - Brookhaven

Brookhaven, Georgia, United States

Luminis Health Research Institute

Annapolis, Maryland, United States

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Oklahoma Sports and Science Orthopedics / The Physician's Group

Oklahoma City, Oklahoma, United States

Palmetto/Prisma Health - University of South Carolina Orthopaedics

Columbia, South Carolina, United States

Steadman Hawkins Clinic of the Carolinas

Greenville, South Carolina, United States

Atlantic Orthopaedic Specialists

Virginia Beach, Virginia, United States

Center for Advanced Orthopaedics / Nova Orthopedic & Spine Care

Woodbridge, Virginia, United States

Memorial Medical Center

Ashland, Wisconsin, United States