Post-market surveillance study to prove the safety and performance of Vanguard PS RP

Post-market surveillance study to prove the safety and performance of Vanguard PS RP - PSRP study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000023965

Enrollment

100

Registered

2016-10-01

Start date

2016-11-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee joint deseases

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patient who requires Total Knee Arthroplasty (including revision arthroplasty) 2)Both Male and female 3)20 or > 20 years of age 4)Patient willing to return for follow-up evaluations

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Implant survivorship at 10 years postoperatively	—

Secondary

Measure	Time frame
Safety, Pain and functional performance of the knee	—

Countries

Japan

Contacts

Public ContactRyo Hasegawa

Zimmer Biomet G.K. Clinical Affairs

Ryo.Hasegawa@zimmerbiomet.com03-6402-6624

Outcome results