Trials / Active Not Recruiting
Active Not RecruitingNCT03409718
Database Retrieval for the Comprehensive Shoulder
Comprehensive Shoulder System Database Retrieval
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 160 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a retrieval of database information regarding survivorship of the Comprehensive Shoulder System family of products. The primary objective of the retrieval is to collect data that will contribute to the post market surveillance requirements for this product and will provide feedback to design engineers, support marketing efforts and publications, and answer potential questions form reimbursement agencies.
Detailed description
The Comprehensive Shoulder System has been cleared by the FDA via premarket notifications. No experimental or investigational surgical techniques or devices will be used in this study. All devices and products will be used in accordance with their instructions for use and/or approved labeling. The aim of the Comprehensive Shoulder System is to improve shoulder function and reduce pain. One site will be used for this database retrieval. The number of patients involved will depend upon the size of the Comprehensive database available at Acromion, LLC.
Conditions
- Osteoarthritis of the Shoulder
- Avascular Necrosis
- Rheumatoid Arthritis
- Prior Failed Revision
- Correction of Functional Deformity
- Fracture of Proximal End of Humerus
- Cuff Tear Arthropathy
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Biomet Comprehensive Shoulder System | Total shoulder system designed to provide intraoperative flexibility for surgeons with unmatched humeral stem options, and infinite humeral head offset possibilities while meeting the growing demand for ease of glenoid preparation through a streamlined, low-profile, cannulated instrument platform |
Timeline
- Start date
- 2011-02-24
- Primary completion
- 2026-02-01
- Completion
- 2026-12-01
- First posted
- 2018-01-24
- Last updated
- 2025-10-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03409718. Inclusion in this directory is not an endorsement.