NCT02084693

COMPREHENSIVE® REVERSE SHOULDER Mini BasePlate

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Rotator Cuff Tear Arthropathy
• Osteoporosis
• Osteomalacia
• Joint; Destruction, Sacroiliac

Interventions

Type	Name	Description
DEVICE	COMPREHENSIVE	Comprehensive® Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.

Timeline

• Start date: 2013-12-01
• Primary completion: 2019-04-01
• Completion: 2019-06-01
• First posted: 2014-03-12
• Last updated: 2019-07-05

Locations

5 sites across 1 country: South Korea