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

NCT03985839 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 299

Last updated 2025-03-17

No results posted yet for this study

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 300 subjects needing reattachment of soft tissue to bone.

Conditions

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

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.

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Mary Ozokwere · Smith & Nephew, Inc.

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2024-08-08
Completion
2024-08-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03985839 on ClinicalTrials.gov