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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023965
Receipt No. R000027587
Scientific Title Post-market surveillance study to prove the safety and performance of Vanguard PS RP
Date of disclosure of the study information 2016/10/01
Last modified on 2018/11/29

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Basic information
Public title Post-market surveillance study to prove the safety and performance of Vanguard PS RP
Acronym PSRP study
Scientific Title Post-market surveillance study to prove the safety and performance of Vanguard PS RP
Scientific Title:Acronym PSRP study
Region
Japan

Condition
Condition Knee joint deseases
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To document the safety and clinical outcomes of the Vanguard PSRP knee system
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Implant survivorship at 2 years postoperatively
Key secondary outcomes Safety, Pain and functional performance of the knee

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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
Key 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
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Nakagawa
Organization Osaka Rosai Hospital
Division name Orthopedic Surgery
Zip code
Address 1179-3, Nagasone-cho, Kita-ku, Sakai, Osaka, Japan
TEL 072-252-3561
Email akira.kashima@zimmerbiomet.com

Public contact
Name of contact person
1st name
Middle name
Last name Fumiya Ohmasa
Organization Zimmer Biomet G.K.
Division name Clinical Affairs
Zip code
Address 15F, Sumitomo Fudosan Shibakoen Tower, 2-11-1, Shibakoen, Minato-ku, Tokyo, Japan
TEL 03-6402-6762
Homepage URL
Email fumiya.ohmasa@zimmerbiomet.com

Sponsor
Institute Zimmer Biomet G.K.
Institute
Department

Funding Source
Organization Zimmer Biomet G.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪労災病院(大阪府)、慶友整形外科病院(群馬県)、埼玉メディカルセンター(埼玉県)、大阪府立急性期・総合医療センター(大阪府)、明野中央病院(大分県)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2019 Year 09 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The evaluation will be done by analysis of standard scoring systems, radiographs and adverse event records.

Management information
Registered date
2016 Year 09 Month 07 Day
Last modified on
2018 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027587

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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