UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001335 |
|---|---|
| Receipt number | R000001622 |
| Scientific Title | Basic and clinical research of pathogenesis of hip pain |
| Date of disclosure of the study information | 2008/08/24 |
| Last modified on | 2009/08/24 11:48:13 |
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Basic information
Public title
Basic and clinical research of pathogenesis of hip pain
Acronym
Basic and clinical research of pathogenesis of hip pain
Scientific Title
Basic and clinical research of pathogenesis of hip pain
Scientific Title:Acronym
Basic and clinical research of pathogenesis of hip pain
Region
| Japan |
Condition
Condition
Osteoarthritis of the hip
Femoral neck fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Osteoarthritis causes pain, limitation of range of motion, and gait disturbance due to degeneration of the articular cartilage. Osteoarthritis is one of the most common disease and about ten milion patients suffer from this condition in Japan. Japanese patients are associated with developmental dysplasia of the hip and acetabular dysplasia. Pathogenesis of hip pain remains unclear about sensory innervation and pain transmission. Hip pain also tends to resist to pain killar. While total hip arthroplasty is effective treatment, revision surgery will be necessary because of the implant loosening. Thus, solution of pain mechanism in osteoarthritis of the hip is needed.
The purpose of this study is to clarify the pathogenesis of hip patin. Basic research evaluates sensory innervation and pain transmitter of human hip joint using immunohistchemistry. Clinical research evaluates destribution of hip pain and referred pain.
Basic objectives2
Others
Basic objectives -Others
Observational study of epidemiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
In basic research, synovium, limbus, femoral head and acetabulum are stained with neuron-specific class III beta-tubulin (TuJ-1), isolectin B4 (IB4), calcitonin gene-related peptide (CGRP), transient receptor potential (TRP), tromyosin receptor kinase (Trk), tumor necrosis factor-alpha (TNFa), nuclear factor-kappa B (NFkB), and p55TNF receptor. Qualitative and quantitative assessments are performed between osteoarthritis and femoral neck fracture.
In clinical research, distribution and incidence of hip pain are evaluated as well as referred pain. Association of hip pain, immunohistchemistry, and image findings are analyzed.
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) Osteoarthritis of the hip
a. Past history of developmental dysplasia or acetabular dysplasia
b. Severe pain and dysfunction
c. Total hip arthroplasty
d. Imformed consent about this study
2) Femoral neck fracture
a. Without developmental dysplasia nor acetabular dysplasia
b. Asymptomatic before injury
c. Hip arthroplasty
d. Imformed consent about this study
Key exclusion criteria
1) Past history of hip trauma, osteonecrosis of the femoral head, rheumatoid arthritis, and rapidly destructive coxarthritis
2) Previous hip surgery
3) Heart failure, respiratory dysfunction, hepatic insufficiency, and renal failure
4) Unfavorable patient condition
5) Inappropriate patient
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | NAKAMURA JUNICHI |
Organization
Graduate School of Medicine, Chiba University
Division name
Orthopaedic Surgery
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba city
TEL
043-226-2117
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | NAKAMURA JUNICHI |
Organization
Graduate School of Medicine, Chiba University
Division name
Orthopaedic Surgery
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba city
TEL
043-226-2117
Homepage URL
shiken@office.chiba-u.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, 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
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 08 | Month | 24 | 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
Completed
Date of protocol fixation
| 2008 | Year | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 08 | Month | 01 | Day |
Other
Other related information
Influential factor: Innervation and inflammatory cytokine
Outcome: pain
Prospective study
Sampling of case control study
Management information
Registered date
| 2008 | Year | 08 | Month | 24 | Day |
Last modified on
| 2009 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001622
