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NCT03199391 · ClinicalTrials.gov registry record · NA
BioWick SureLock Clinical Outcomes Study
A NA study of Rotator Cuff Tear, sponsored by Zimmer Biomet.
- Completed
- Registry status
- NA
- Development phase
- 71
- Enrollment target
- 7
- Study locations
NCT03199391: Completed NA study of Rotator Cuff Tear, sponsored by Zimmer Biomet.
NCT03199391 is a NA study of Rotator Cuff Tear that has completed, run by Zimmer Biomet. The registered enrollment target is 71 participants, below the 87-participant average among 11 other Rotator Cuff Tear trials with a reported enrollment target (18% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03199391, a NA study of Rotator Cuff Tear, has completed, sponsored by Zimmer Biomet.
- COMPLETED
- Registry status
- NA
- Development phase
- 71 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
The primary endpoint of this study is survivorship (lack of reoperation/device removal) at 12 months postoperative. Implant survivorship for each subject was determined by whether the subject underwent a revision or reoperation of the study device. Survivorship was assessed using a Kaplan-Meier analysis. Possible scores range from 0% (lowest survivorship) to 100% (highest survivorship).
Conditions Studied
Interventions
- DEVICE BioWick SureLock Implant
Study Locations (7)
Florida
- Orthopaedic Medical Group of Tampa Bay PA - Brandon
- Foundation for Orthopaedic Research and Eduation - Temple Terrace
Arizona
- The Orthopaedic Clinic Association - Phoenix
California
- Eisenhower Medical Center - Rancho Mirage
Kentucky
- Norton Orthopaedics and Sports Medicine - Louisville
Utah
- University of Utah - Salt Lake City
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2017-04-26 |
| Est. Completion | 2021-05-05 |
| Phase | NA |
What the finished NCT03199391 record still lists
NCT03199391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 87-participant average among 11 other Rotator Cuff Tear trials with a reported enrollment target (18% lower).
The record links to 1 condition, with Rotator Cuff Tear appearing as the primary indexed condition, and to 1 intervention - of which BioWick SureLock Implant is the first listed.
NCT03199391 lists 7 locations in 6 states (Florida, Arizona, California).
Frequently Asked Questions
What is clinical trial NCT03199391 about?
NCT03199391 is a clinical study titled "BioWick SureLock Clinical Outcomes Study". 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.
What is the current status of trial NCT03199391?
This trial is currently completed. It is a NA study. The enrollment target is 71 participants. The study started on 2017-04-26. Estimated completion is 2021-05-05.
What conditions does trial NCT03199391 study?
This clinical trial studies the following conditions: Rotator Cuff Tear.
What interventions are being tested in trial NCT03199391?
The interventions under investigation include: BioWick SureLock Implant (DEVICE).
Who is sponsoring clinical trial NCT03199391?
This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03199391 being conducted?
This trial has 7 study locations across Arizona, California, Florida, Kentucky, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Rotator Cuff Tear
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03199391's enrollment target sits among peer trials
71 7th of 11 higher than 5 of 11 other Rotator Cuff Tear trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rotator Cuff Tear trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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