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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004763
Receipt No. 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

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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
Email

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
Email njonedr@yahoo.co.jp

Sponsor
Institute Graduate School of Medicine, Chiba University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005670

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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