About this trial
This study is a Multi-center, Prospective Follow-up, Non-significant risk, Post-Market Clinical Follow-Up (PMCF) study to Evaluate the Safety and Effectiveness of the Tornier Perform™ Reversed MonoPost System.
Eligibility criteria
Qualifiers
18 years or older at the time of the informed consent.
Informed and willing to sign an informed consent form (ICF) approved by Institutional Review Board (IRB) or Ethics Committee (EC).
Willing and able to comply with the requirements of the study protocol
Rheumatoid arthritis
Disqualifiers
Contraindications or hypersensitivity to the use of the Tornier Perform™ Reversed MonoPost System or their components (e.g., metal sensitivity).
Participation in the treatment period of another clinical trial during the clinical investigation.
Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.44. Examples include any subject "with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished
Trial design
Treatments tested in this trial
- Tornier Perform™ Reversed MonoPost