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New anchors aim to keep shoulders and hips stable after injury

NCT ID NCT03985839

Disease control Sponsor: Smith & Nephew, Inc. Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This trial evaluates the safety and performance of three types of suture anchors (REGENESORB, Knotless REGENESORB, and Knotless PEEK) used to reattach soft tissue to bone in the shoulder or hip. About 300 people needing repair for labral tears, shoulder instability, or rotator cuff tears are enrolled. Researchers track how often repairs fail within 6 and 12 months, using MRI or CT scans to confirm any issues.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MICRORAPTOR REGENESORB, Knotless REGENESORB, and Knotless PEEK suture anchors
What this could lead to
If successful, these anchors could offer a reliable option for repairing torn labrums and stabilizing shoulders and hips, potentially reducing re-tear rates.
What could go wrong
This is a post-market study confirming safety in real-world use, not a test of a new breakthrough. Repair failure or complications like infection or anchor loosening are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

298 people

The number who actually took part.

Started

Aug 2019

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subject requires reattachment of soft tissue to bone for the following indications: * Shoulder - Capsular stabilization for Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions, Biceps tenodesis, Rotator Cuff Repairs (knotless anchors only) * Hip - Acetabular labrum repair/reconstruction

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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 2. 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. 3. Subject is ≥12 years of age at time of surgery. 4. Willing and able to make all required study visits. 5. Able to follow instructions. Exclusion Criteria: 1. Known hypersensitivity to the implant material. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation. 2. Pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation. 3. Pathological conditions in the soft tissues to be attached that would impair secure fixation by suture. 4. Comminuted bone surface, which would compromise secure anchor fixation. 5. Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing. 6. The presence of infection. 7. Conditions which would limit the subject's ability or willingness to restrict activities or follow directions during the healing period. 8. Currently using tobacco products (cigarette, smokeless tobacco, e-cigarettes, vaping etc.). 9. Concurrent bilateral surgery. 10. Prior MICRORAPTOR™ REGENESORB™, MICRORAPTOR™ Knotless REGENESORB™ or MICRORAPTOR™ Knotless PEEK implantation. 11. Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1, or during the study. 12. Women who are pregnant or nursing. 13. History of poor compliance with medical treatment. 14. Prior ipsilateral surgeries performed on the joint space. 15. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

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Conditions

The condition(s) this trial relates to.

Bankart Lesions Rotator Cuff Injuries rotator cuff syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acetabular labrum tear Anterior shoulder instability Bankart lesions Labral tear, glenoid Rotator cuff tears Slap lesion

Contacts and locations

Locations

  • Atlantic Orthopaedic Specialists

    Virginia Beach, Virginia, 23452, United States

  • Center for Advanced Orthopaedics / Nova Orthopedic & Spine Care

    Woodbridge, Virginia, 22191, United States

  • Colorado Springs Orthopaedic Group

    Colorado Springs, Colorado, 80920, United States

  • Emory University - Brookhaven

    Brookhaven, Georgia, 30329, United States

  • Holy Cross Orthopedic Institute

    Oakland Park, Florida, 33334, United States

  • Luminis Health Research Institute

    Annapolis, Maryland, 21401, United States

  • Memorial Medical Center

    Ashland, Wisconsin, 54806, United States

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43202, United States

  • Oklahoma Sports and Science Orthopedics / The Physician's Group

    Oklahoma City, Oklahoma, 73114, United States

  • Palmetto/Prisma Health - University of South Carolina Orthopaedics

    Columbia, South Carolina, 29203, United States

  • Steadman Hawkins Clinic of the Carolinas

    Greenville, South Carolina, 29615, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

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