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The main objectives of this study are to evaluate overall clinical performance and safety of the Persona Ti-Nidium implant in total knee arthroplasty.
Full description
The study design is a prospective, multicenter data collection model of the 510(k) cleared Persona Ti-Nidium Total Knee System. The study will require each site to obtain institutional review board (IRB) approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. Investigators will collect clinical data for a required 10 years. Follow-up clinical visits include Early Post-op, 6 months, 1 year, 2, 3, 5, 7 and 10 years post-operatively.
The objective of this study is to evaluate clinical performance, benefits and safety of the Persona Ti-Nidium implant in total knee arthroplasty.
Specific assessments include:
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Inclusion criteria
Study Device Inclusion Criteria:
The Persona Ti-Nidium Total Knee is intended for patients with severe pain and disability due to the following:
Exclusion criteria
Study Device Exclusion Criteria
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240 participants in 1 patient group
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Central trial contact
Cayla LaFollette
Data sourced from clinicaltrials.gov
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