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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006653
Receipt No. R000007866
Scientific Title Trabecular Metal Primary Hip Prosthesis Registry Study -Multicenter clinical research in Japan and US-
Date of disclosure of the study information 2011/11/04
Last modified on 2016/06/08

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Basic information
Public title Trabecular Metal Primary Hip Prosthesis Registry Study -Multicenter clinical research in Japan and US-
Acronym TM Stem Registry Study -Multicenter clinical research in Japan and US
Scientific Title Trabecular Metal Primary Hip Prosthesis Registry Study -Multicenter clinical research in Japan and US-
Scientific Title:Acronym TM Stem Registry Study -Multicenter clinical research in Japan and US
Region
Japan North America

Condition
Condition Patients who have been diagnosed Osteoarthritis, Rheumatoid Arthritis and Avascular Necrosis, etc.
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To obtain preoperative, operative and postoperative clinical outcomes and radiographic data on the Trabecular Metal Primary Hip Prosthesis used in primary or revision total hip arthroplasty.
Basic objectives2 Others
Basic objectives -Others To pool the clinical data.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To obtain preoperative, operative and postoperative clinical outcomes and radiographic data
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Trabecular Metal Primary Hip Prosthesis by THA
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.atient is &#8805; 18 years of age.
2.Patient is in stable health and able to undergo surgery.
3.Patient suffers from severe hip pain and disability requiring total, hemi or revision hip replacement.
4.Patient is willing and able to cooperate in prescribed post-operative therapy.
5.Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
6.Patient has participated in the Informed Consent process and has signed an IRB approved Informed Consent.
Key exclusion criteria 1.Patient is &#8805; 18 years of age.
2.Patient with an acute, chronic, local or systemic infection.
3.Patient is skeletally immature.
4.Patient is pregnant.
5.Patient is a prisoner, mentally incompetent and/or anticipated to be non-compliant.
6.Patient has a known allergy to one of the constituents of the implant, e.g. cobalt, chromium, nickel, etc.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Hirakawa
Organization Shonan Kamakura Joint Reconstruction Center
Division name Department of Orthopaedic Surgery
Zip code
Address 5-4-17, Dai, Kamakura, Kanagawa prefecture, Japan
TEL 0467-47-2377
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akira Saito
Organization Shonan Kamakura Joint Reconstruction Center
Division name Department of Orthopaedic Surgery
Zip code
Address 5-4-17, Dai, Kamakura, Kanagawa prefecture, Japan
TEL 0467-47-2377
Homepage URL
Email akikun@jcom.home.ne.jp

Sponsor
Institute Shonan Kamakura Joint Reconstruction Center
Institute
Department

Funding Source
Organization Zimmer Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 医療法人 沖縄徳洲会 湘南鎌倉人工関節センター

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 04 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
2011 Year 10 Month 12 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2023 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 11 Month 02 Day
Last modified on
2016 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007866

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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