NCT03199391

BioWick SureLock Clinical Outcomes Study

Efficacy of the BioWick SureLock Implant for the Reattachment of Soft Tissue to Bone in Subjects Undergoing Rotator Cuff Repairs

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to collect postmarket data in subjects who receive surgical treatment of a full-thickness rotator cuff tear (of at least 1.5 cm) with the BioWick™ SureLock™ implant. Both performance and safety data will be collected.

Detailed 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 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.

Conditions

• Rotator Cuff Tear

Interventions

Type	Name	Description
DEVICE	BioWick SureLock Implant	The BioWick SureLock implant is a device for shoulder and extremity surgery, constructed of Ultra High Molecular Weight Polyethylene Suture. BioWick SureLock is uniquely designed to minimize these risks by avoiding manual tensioning with an inserter mechanism that ensures that the implant is consistently deployed below the cortex.

Timeline

• Start date: 2017-04-26
• Primary completion: 2021-05-05
• Completion: 2021-05-05
• First posted: 2017-06-26
• Last updated: 2022-07-07
• Results posted: 2022-05-25

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study