Comprehensive Nano - Post Market Clinical Follow-Up Study

Zimmer Biomet

Status

Active, not recruiting

Conditions

Osteoarthritis

Correction of Functional Deformity

Revision

Avascular Necrosis

Rheumatoid Arthritis

Treatments

Device: Comprehensive Nano

Study type

Observational

Funder types

Industry

Identifiers

NCT03423953

ORTHO.CR.GE2.13

Details and patient eligibility

About

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.

Full 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.

Enrollment

194 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
Rheumatoid arthritis
Revision where other devices or treatments have failed
Correction of functional deformity.
Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate
Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate

Exclusion criteria