NIPH Clinical Trials Search

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) studiedKnee joint deseases
Date of first enrollment2016/11/18
Target sample size100
Countries of recruitmentJapan
Study typeObservational


Primary OutcomeImplant survivorship at 10 years postoperatively
Secondary OutcomeSafety, Pain and functional performance of the knee

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1)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


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
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
Affiliation Osaka Rosai Hospital Orthopedic Surgery