UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023965
Receipt number 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 2023/07/25 09:19:36

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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 10 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 Shigeru
Middle name
Last name Nakagawa

Organization

Osaka Rosai Hospital

Division name

Orthopedic Surgery

Zip code

591-8025

Address

1179-3, Nagasone-cho, Kita-ku, Sakai, Osaka, Japan

TEL

072-252-3561

Email

Ryo.Hasegawa@zimmerbiomet.com


Public contact

Name of contact person

1st name Ryo
Middle name
Last name Hasegawa

Organization

Zimmer Biomet G.K.

Division name

Clinical Affairs

Zip code

105-0011

Address

15F, Sumitomo Fudosan Shibakoen Tower, 2-11-1, Shibakoen, Minato-ku, Tokyo, Japan

TEL

03-6402-6624

Homepage URL


Email

Ryo.Hasegawa@zimmerbiomet.com


Sponsor or person

Institute

Zimmer Biomet G.K.

Institute

Department

Personal name



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

NA

Address

NA

Tel

NA

Email

NA


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

100

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

Completed

Date of protocol fixation

2016 Year 08 Month 17 Day

Date of IRB

2016 Year 10 Month 20 Day

Anticipated trial start date

2016 Year 11 Month 18 Day

Last follow-up date

2023 Year 08 Month 31 Day

Date of closure to data entry

2023 Year 10 Month 31 Day

Date trial data considered complete

2023 Year 11 Month 30 Day

Date analysis concluded

2023 Year 12 Month 31 Day


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

2023 Year 07 Month 25 Day



Link to view the page

Value
https://center6.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