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

Completed

Conditions studied: Labral Tear, Glenoid, Acetabular Labrum Tear, Bankart Lesions, Anterior Shoulder Instability, SLAP Lesion, Rotator Cuff Tears

In brief

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.

Key facts

Study ID

NCT03985839

Run by

Smith & Nephew, Inc.

People needed

298

Starts

2019-08-01

Expected to finish

2024-08-08

Last updated by the study team

2026-07-13

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject requires reattachment of soft tissue to bone for one of the following indications:
• Shoulder - Capsular stabilization for Bankart repair, anterior shoulder instability, superior labrum from anterior to posterior (SLAP) lesion repairs, capsular shift or capsulolabral reconstructions; biceps tenodesis (knotless anchors only)
• Hip - Acetabular labrum repair/reconstruction
• Subject if ≥ 18 years of age or legally authorized representative if subject is <18 years of age has consented to participate in the study by signing the IRB approved informed consent form. If <18 years of age, subject has assented to participate in the study by signing the IRB approved assent form.
• Subject is ≥12 years of age at time of surgery.
• Willing and able to make all required study visits.
• Able to follow instructions.

You may not qualify if…

• Known hypersensitivity to the implant material. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.
• Pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation.
• Pathological conditions in the soft tissues to be attached that would impair secure fixation by suture.
• Comminuted bone surface, which would compromise secure anchor fixation.
• Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing.
• The presence of infection.
• Conditions which would limit the subject's ability or willingness to restrict activities or follow directions during the healing period.
• Currently using tobacco products (cigarette, smokeless tobacco, e-cigarettes, vaping etc.).
• Concurrent bilateral surgery.
• Prior MICRORAPTOR™ REGENESORB™, MICRORAPTOR™ Knotless REGENESORB™ or MICRORAPTOR™ Knotless PEEK implantation.
• Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1, or during the study.
• Women who are pregnant or nursing.
• History of poor compliance with medical treatment.
• Prior ipsilateral surgeries performed on the joint space.
• Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Where it is running

• 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

Full record on ClinicalTrials.gov

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