UMIN ID: UMIN000016779
Registered date:11/03/2015
Prospective, Multi-centre Outcomes Study of Persona Knee System in TKA
Basic Information
Recruitment status | Complete: follow-up complete |
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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 |
Intervention(s) |
Outcome(s)
Primary Outcome | Implant survivorship/ Implant revision rate |
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Secondary Outcome | Patient Reported Outcomes, Clinical Assessments, Safety Assessment, and CT image Analysis |
Key inclusion & exclusion criteria
Age minimum | 18years-old |
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Age maximum | 80years-old |
Gender | Male and Female |
Include criteria | |
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. |
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Secondary Sponsor | |
Source(s) of Monetary Support | Zimmer Biomet G.K. |
Secondary ID(s) | CTRI/2014/09/005055 |
Contact
public contact | |
Name | Yukako Shiraishi |
Address | 15F, Sumitomo Fudosan Shibakoen Tower, 2-11-1, Shibakoen, Minato-ku, Tokyo, Japan Japan 105-0011 |
Telephone | 03-6402-6610 |
yukako.shiraishi@zimmerbiomet.com | |
Affiliation | Zimmer Biomet G.K. Clinical Affairs |
scientific contact | |
Name | Yukako Shiraishi |
Address | 15F, Sumitomo Fudosan Shibakoen Tower, 2-11-1, Shibakoen, Minato-ku, Tokyo, Japan Japan |
Telephone | 03-6402-6610 |
yukako.shiraishi@zimmerbiomet.com | |
Affiliation | Zimmer Biomet G.K. Clinical Affairs |