Prospective Multicenter Post-Market 1 year Clinical Follow-up Study to evaluate safety and performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors in shoulder and hip arthroscopic repair

Brief description of study

The purpose of this research is to confirm the safety and performance of the commonly used SUTUREFIX ULTRA and SUTUREFIX CURVED All-Suture Anchors, which are manufactured by Smith+Nephew, the sponsor of this study. These suture anchors are US Food and Drug Administration (FDA) approved for hip or shoulder instability repair, and are designed primarily for arthroscopic repair. This device is used routinely at NYU Langone as one of the standard of care treatment options for this condition. During this study, the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors will be used in the same way that your surgeon would have used them even if you did not want to take part in the study. After your surgery, data will be collected about your medical history, surgery and post-operative follow-up. The researchers will find out how well SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchor works by observing the outcome of both Suture Anchors.


Clinical Study Identifier: s19-01328
ClinicalTrials.gov Identifier: NCT03691298
Principal Investigator: Andrew S Rokito
Currently Recruiting

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