Tornier Perform™ Reversed Monopost Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorStryker Trauma and Extremities

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

Treatment groups

150 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators