Status:
WITHDRAWN
PMCF Study on the Safety, Performance and Clinical Benefits Data of the NexGen TM Augmentation Patella
Lead Sponsor:
Zimmer Biomet
Conditions:
Rheumatoid Arthritis
Non-inflammatory Degenerative Joint Disease
Eligibility:
All Genders
18+ years
Brief Summary
The study is a single-center, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and cl...
Detailed Description
The Nexgen TM Augmentation Patella is intended to help compensate for significant bone loss in the patella during revision total knee arthroplasty. One site will be involved in this study. The aim is...
Eligibility Criteria
Inclusion
- Non-inflammatory degenerative joint disease including osteoarthritis or traumatic arthritis
- Rheumatoid arthritis
- Correction of functional deformity
- Revision procedures where other treatments or devices have failed
- Treatment of fractures that are unmanageable using other techniques
- Complication from a failed prosthesis
- For cementless use only
- Supplemental fixation, when required, must be achieved by means of suture attachment.
Exclusion
- Off-label use
- Primary arthroplasty
- Overt Infection
- Distant foci of infection (which may spread hematogenously to the implant site)
- Rapid disease progression as manifested by joint destruction or bone resorption apparent on roentgenogram
- Skeletally immature patients
- Cases where there is inadequate bone stock or no bone stock which would make the procedure unjustifiable
- Patients who are not willing to return for study required follow-up visits and/or are not willing to comply with the follow-up schedule
- Patient who is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant, younger than 18 years)
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2034
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05253976
Start Date
September 1 2022
End Date
December 31 2034
Last Update
December 24 2024
Active Locations (1)
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1
Insel Spital
Bern, Switzerland, 3010