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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032711
Receipt No. R000037301
Official scientific title of the study OUTCOMES OF HIP ARTHROPLASTY USING A DEPUY PINNACLE GRIPTION CUP
Date of disclosure of the study information 2018/06/10
Last modified on 2018/05/31

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Basic information
Official scientific title of the study OUTCOMES OF HIP ARTHROPLASTY USING A DEPUY PINNACLE GRIPTION CUP
Title of the study (Brief title) Pinnacle Gription Registry
Region
Japan

Condition
Condition Patients who are indicated for primary total hip replacement including the following disease.
-Rheumatoid arthritis
-Hip Osteoarthritis
-Avascular necrosis of the femoral head
-Fracture of the femoral head
-Acampsia
-Arthrodesia, Osteotomy,
Post-operative of femoral head replacement
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the clinical outcomes of a series of total hip replacements using the DePuy Pinnacle Gription cup through clinical and radiographic assessments.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluate the clinical outcomes of a series of total hip replacements using the DePuy Pinnacle Gription cup
Key secondary outcomes

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. Patients 20 years of age or older at the time of consent
2. Primary Total hip replacement for any indication in accordance with the Instruction for Use accompanying the implant
3. Signed informed patient consent form
Key exclusion criteria None
Target sample size 300

Research contact person
Name of lead principal investigator Ayumi Kaneuji
Organization Kanazawa Medical University Hospital
Division name Department of Orthopedics
Address 1-1 Daigaku Uchinadamachi Kahoku-gun, Ishikawa Japan
TEL 076-286-3511
Email orthoped@kanazawa-med.ac.jp

Public contact
Name of contact person Akiko Sano
Organization Johnson & Johnson K.K. Medical Company
Division name Clinical Research
Address 5-2 Nishi-kanda 3-chome, Chiyoda-ku, Tokyo Japan
TEL 03-4411-6789
Homepage URL
Email asano1@its.jnj.com

Sponsor
Institute Johnson & Johnson K.K.
Medical Company
Institute
Department

Funding Source
Organization Johnson & Johnson K.K.
Medical Company
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 10 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 04 Month 27 Day
Anticipated trial start date
2018 Year 07 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information This series of total hip replacement Patients will be required interval windows: Pre-Op/Operative/Post-op, 6 months, 1 year, 2 years.

Management information
Registered date
2018 Year 05 Month 24 Day
Last modified on
2018 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037301

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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