BioWick SureLock Clinical Outcomes Study

Summary

Participation Requirements

Description

Study Title Efficacy of the BioWick SureLock Implant for the Reattachment of Soft Tissue to Bone in Subjects Undergoing Rotator Cuff Repairs Sponsor Cayenne Medical, Inc., a Zimmer Biomet company Study Design The study is a prospective, non-randomized, open-label, single-arm study that includes both...

Study Title Efficacy of the BioWick SureLock Implant for the Reattachment of Soft Tissue to Bone in Subjects Undergoing Rotator Cuff Repairs Sponsor Cayenne Medical, Inc., a Zimmer Biomet company Study Design The study is a prospective, non-randomized, open-label, single-arm study that includes both preoperative assessments and follow-up assessments at 3 months, 6 months, and 12 months. Clinical Phase Postmarket Number of Sites Up to ten sites in the U.S. Study Duration per Subject Subjects will be enrolled in the study for up to 12 months. Primary Objective The primary objective of this study is to assess survivorship (lack of reoperation/device removal) with the use of the BioWick SureLock implant. Secondary Objective The secondary objectives of this study are: To document the postmarket effectiveness of the BioWick SureLock implant using ASES scores, VR-12 scores, and VAS scores, with the corresponding assessments made at 3 months, 6 months, and 12 months postoperative. To document the postmarket effectiveness of the BioWick SureLock implant using range of motion (ROM) measurements with the corresponding assessments made at 3 months and 6 months postoperative. To document device safety via device-related adverse events reported over the course of the study.

Tracking Information