NCT03423953

Comprehensive Nano - Post Market Clinical Follow-Up Study

Comprehensive Nano Post Market Data Collection

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 194 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

This data collection project is intended to provide clinical outcomes data to engineering, marketing as well as fulfill the post market surveillance requirements of various regulatory authorities. The study will be a prospective and one-arm.

Detailed description

The Comprehensive® Shoulder System with Nano humeral component is a humeral prosthesis system intended for use in total or hemi shoulder arthroplasty surgery. Total shoulder arthroplasty consists of replacement of the humeral head and glenoid. Hemi-arthroplasty consists of replacement of only the humeral head. This project is a prospective study including one-hundred and fifty (150) anatomic and hemi cases and 44 reverse shoulders collected from up to ten (10) sites. All potential study subjects will be required to participate in the Informed Consent process.

Conditions

• Osteoarthritis
• Avascular Necrosis
• Rheumatoid Arthritis
• Revision
• Correction of Functional Deformity

Interventions

Type	Name	Description
DEVICE	Comprehensive Nano	Patients requiring the Comprehensive Nano shoulder system.

Timeline

• Start date: 2013-10-30
• Primary completion: 2030-07-31
• Completion: 2030-07-31
• First posted: 2018-02-06
• Last updated: 2025-02-10

Locations

5 sites across 4 countries: Austria, Canada, South Korea, United Kingdom