UMIN ID: UMIN000023965
Registered date:01/10/2016
Post-market surveillance study to prove the safety and performance of Vanguard PS RP
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Knee joint deseases |
Date of first enrollment | 2016/11/18 |
Target sample size | 100 |
Countries of recruitment | Japan |
Study type | Observational |
Intervention(s) |
Outcome(s)
Primary Outcome | Implant survivorship at 10 years postoperatively |
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Secondary Outcome | Safety, Pain and functional performance of the knee |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1)Infection, sepsis, and osteomyelitis 2)Sensitivity for material of the investigational implant 3)Uncooperative patient or patient with neurologic disorders who are incapable of following directions 4)Pregnancy |
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) |
Contact
public contact | |
Name | Ryo Hasegawa |
Address | 15F, Sumitomo Fudosan Shibakoen Tower, 2-11-1, Shibakoen, Minato-ku, Tokyo, Japan Japan 105-0011 |
Telephone | 03-6402-6624 |
Ryo.Hasegawa@zimmerbiomet.com | |
Affiliation | Zimmer Biomet G.K. Clinical Affairs |
scientific contact | |
Name | Shigeru Nakagawa |
Address | 1179-3, Nagasone-cho, Kita-ku, Sakai, Osaka, Japan Japan |
Telephone | 072-252-3561 |
Ryo.Hasegawa@zimmerbiomet.com | |
Affiliation | Osaka Rosai Hospital Orthopedic Surgery |