Status:
ACTIVE_NOT_RECRUITING
Comprehensive Nano - Post Market Clinical Follow-Up Study
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis
Avascular Necrosis
Eligibility:
All Genders
18+ years
Brief 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...
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 r...
Eligibility Criteria
Inclusion
- 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
- Infection
- Sepsis
- osteomyelitis
Key Trial Info
Start Date :
October 30 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2030
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT03423953
Start Date
October 30 2013
End Date
July 31 2030
Last Update
February 10 2025
Active Locations (5)
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1
Privatklinik Leech
Graz, Styria, Austria, 8010
2
Kingston General Hospital
Kingston, Ontario, Canada, K7L 3N6
3
Chonnam National University Hospital
Gwangju, South Korea
4
Samsung Medical Centre
Seoul, South Korea, 06351