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
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
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
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
