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 |
|---|---|
| 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 |
|---|---|
| Secondary Outcome | Safety, Pain and functional performance of the knee |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| 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. |
|---|---|
| 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 |