UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004763 |
|---|---|
| Receipt number | R000005670 |
| Scientific Title | Evaluation of articular cartilage in hip disease using Discovery MR750 3.0T research pack 3.0 (cube T1 rho, ultra short TE etc.) |
| Date of disclosure of the study information | 2010/12/21 |
| Last modified on | 2010/12/21 13:12:48 |
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Basic information
Public title
Evaluation of articular cartilage in hip disease using Discovery MR750 3.0T research pack 3.0 (cube T1 rho, ultra short TE etc.)
Acronym
MRI study of articular cartilage in hip disease
Scientific Title
Evaluation of articular cartilage in hip disease using Discovery MR750 3.0T research pack 3.0 (cube T1 rho, ultra short TE etc.)
Scientific Title:Acronym
MRI study of articular cartilage in hip disease
Region
| Japan |
Condition
Condition
Hip disease
Classification by specialty
| Orthopedics | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Osteoarthritis is a painful disorder characterized by degeneration of articular cartilage, resulting in restrictions on the range of motion and gait disturbances. Osteoarthritis is one of the most common diseases among musculoskeletal disorders and is expected to affect more than 10 million Japanese patients. Osteoarthritis of the hip, which is often secondary to developmental dysplasia of the hip and acetabular dysplasia, causes deterioration in the quality of life and impairs activities of daily living in middle-aged people. Non-steroidal anti-inflammatory drugs are sometimes ineffectual for chronic pain of the hip, in part because our understanding of the pathogenesis of hip pain is quite limited regarding sensory innervation and pain transmitting substances in the hip joint. Although total hip arthroplasty is effective in treating painful hips, the medical cost of this surgical approach is estimated to be well over hundreds of millions of dollars. Aseptic loosening and the need for revision surgery are the other drawbacks of total hip arthroplasty.
The cost to society of surgical treatment potentially could be sharply reduced with the development of new, more effective diagnostic tool for cartilage degeneration. GE discovery 750R is the latest Magnetic Resonance Imaging unit with the highest magnetic field of 3.0 Tesla. Althogh it can perform whole body imaging with fast and high quality, its effectiveness has not been investigated especially in hip disease. The purpose of this study is to clarify the quantitative evaluation of articular cartilage of the acetabulum and the femoral head using research pack 3.0 ( cube T1 rho, ultra short TE, T2 mapping and so on).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Radial MR imaging, T2 mapping, dGEMRIC, 3D-SPGR, DWI, COSMIC, cine MRI, cube T1 rho, ultra short TE, etc.
Thickness, signal intensity change, localization, topographic Variation of articular cartilage of the acetabulum, the femoral head, and limbus.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 10 healthy volunteers
2) 20 patients with hip disease, including osteoarthritis of the hip, osteonecrosis of the femoral head, acetabular dysplasia, developmental dysplasia of the hip, Perthes disease, slipped capital femoral epiphysis, osteochondritis dissecans.
Sample size may be added.
Key exclusion criteria
1) previous hip surgery
2) pacemaker, metal implantation, or tatoo
3) heart failure, lung failure, and liver failure.
4) renal failure with less than 30mL/min/1.73m2 of eGFR
5) allergy to gadlinium
6) claustrophobia
7) difficulty with rest in supine position for 30 min
8) difficulty with regulation of body temperature
9) expectant mother
10) others
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Motoori |
Organization
Graduate School of Medicine, Chiba University
Division name
Radiology
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Nakamura |
Organization
Chiba University Hospital
Division name
Orthopaedic Surgery
Zip code
Address
TEL
043-226-2117
Homepage URL
njonedr@yahoo.co.jp
Sponsor or person
Institute
Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Teikyo University Chiba Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
千葉大学医学部附属病院(千葉県)、千葉大学大学院医学研究院(千葉県)、帝京大学ちば総合医療センター(千葉県)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 21 | 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
| 2010 | Year | 10 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | 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
prospective observational study
case control
Management information
Registered date
| 2010 | Year | 12 | Month | 21 | Day |
Last modified on
| 2010 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005670
