UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006653 |
|---|---|
| Receipt number | 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 | 2020/11/24 09:44:01 |
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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 ≥ 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 ≥ 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 | Kazuo |
| Middle name | |
| Last name | Hirakawa |
Organization
Shonan Kamakura Joint Reconstruction Center
Division name
Department of Orthopaedic Surgery
Zip code
247-0061
Address
5-4-17, Dai, Kamakura, Kanagawa prefecture, Japan
TEL
0467-47-2377
mail@skjrc.jp
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Hirakawa |
Organization
Shonan Kamakura Joint Reconstruction Center
Division name
Department of Orthopaedic Surgery
Zip code
247-0061
Address
5-4-17, Dai, Kamakura, Kanagawa prefecture, Japan
TEL
0467-47-2377
Homepage URL
akikun@jcom.home.ne.jp
Sponsor or person
Institute
Shonan Kamakura Joint Reconstruction Center
Institute
Department
Personal name
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
Mirai Iryo Research Center
Address
1-8-7, Koji-machi, Chiyoda-ku, Tokyo 102-0083, Japan
Tel
0332634801
mirai-ec1@mirai-iryo.com
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
| 2020 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007866
