COMPREHENSIVE® REVERSE SHOULDER Mini BasePlate

Status Completed

Clinical Trial Summary

Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.

Clinical Trial Description

The primary objective of this prospective clinical data collection is to evaluate survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate. Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes including adverse events, scapular notching, and Constant Score.

All shoulders on which data will be collected are legally marketed and none of the devices are investigational or experimental. FDA has cleared this device via Premarket Notification 510(k) K080642. This data collection effort will document the clinical outcomes of the Comprehensive® Reverse shoulders. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02084693
Study type	Observational
Source	Zimmer Biomet
Contact
Status	Completed
Phase
Start date	December 2013
Completion date	June 2019

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