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

Email



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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name