Prospective, Multi-centre Outcomes Study of Persona Knee System in TKA

UMIN ID: UMIN000016779

Registered date:11/03/2015

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Knee Arthroplasty
• Date of first enrollment: 2015/02/09
• Target sample size: 1000
• Countries of recruitment: Japan,Asia(except Japan),Australia
• Study type: Observational

Outcome(s)

• Primary Outcome: Implant survivorship/ Implant revision rate
• Secondary Outcome: Patient Reported Outcomes, Clinical Assessments, Safety Assessment, and CT image Analysis

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1. Currently participating in any other surgical intervention studies or pain management studies 2. Previous history of infection in the affected joint and/or other local/ systemic infection that may affect the prosthetic joint 3. Insufficient bone stock on femoral or tibial surfaces 4. Skeletal immaturity 5. Neuropathic arthropathy 6. Any loss of musculature or neuromuscular disease that compromises the affected limb 7. Stable, painless arthrodesis in a satisfactory functional position 8. Severe instability secondary to the absence of collateral ligament integrity 9. Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin 10. Known or suspected sensitivity or allergy to one or more of the implant materials 11. Pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.) 12. Previously received partial or total knee arthroplasty for the ipsilateral knee

Related Information

• Primary Sponsor: Zimmer Biomet G.K.
• Source(s) of Monetary Support: Zimmer Biomet G.K.
• Secondary ID(s): CTRI/2014/09/005055