UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003543 |
|---|---|
| Receipt number | R000004225 |
| Scientific Title | A Prospective Controlled Multi-Center Study on METAL-ON-METAL Total Hip Arthroplasty |
| Date of disclosure of the study information | 2010/05/20 |
| Last modified on | 2010/04/26 19:01:00 |
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Basic information
Public title
A Prospective Controlled Multi-Center Study on METAL-ON-METAL Total Hip Arthroplasty
Acronym
Metal-on-Metal Study
Scientific Title
A Prospective Controlled Multi-Center Study on METAL-ON-METAL Total Hip Arthroplasty
Scientific Title:Acronym
Metal-on-Metal Study
Region
| Japan | Asia(except Japan) |
Condition
Condition
Patients suitable for primary Total Hip Replacement
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate clinicl efficacy and performance of Metal-on-Metal Total Hip Arthroplasty
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Range of Motion, Dislocation Rate, Adverse Events
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Device: M2a Magnum
Observation period: Post-Op 2 year (Maximal length 10 year)
Interventions/Control_2
Device: M2a Taper
Observation period: Post-Op 2 year (Maximal length 10 year)
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
Patients suitable for primary Total Hip Replacement.
Patients with limited co-morbidity - ASA I - III.
Patients must be able to understand instructions and be willing to return for follow-up.
Key exclusion criteria
Pre-existing metal implants.
Absolute contraindications include: infection, sepsis, and osteomyelitis.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Ohzono |
Organization
Kansai Rosai Hospital
Division name
Orthopaedic Surgery
Zip code
Address
3-1-69 inobaso, Amagasaki City, Hyogo Pref.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kansai Medical University Takii Hospital
Division name
Orthpaedic Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Biomet Japan, Inc.
Institute
Department
Personal name
Funding Source
Organization
Biomet Japan, Inc.
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01010763
Org. issuing International ID_1
ClinicalTraials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 26 | Day |
Last modified on
| 2010 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004225
