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Clinical Trial 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.


Clinical Trial Description

The purpose of this trial is to assess, by product, safety and performance post-market of the Microraptor Regenesorb, Microraptor Knotless Regenesorb, and Microraptor Knotless PEEK Suture Anchors. Approximately 18 sites (approximately 3 sites for study shoulder group and 3 sites for study hip group, per product) in the United States will participate in the study. This is an open-label study with consecutive enrollment. The study will continue for 24 months from the date that the last subject received the study treatment to the date that the last subject completes the study as planned. The study duration is planned for 36 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03985839
Study type Observational
Source Smith & Nephew, Inc.
Contact
Status Active, not recruiting
Phase
Start date August 1, 2019
Completion date April 29, 2024

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