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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009250
Receipt No. R000010863
Scientific Title The clinical trial investigating the safety in the treatment of osteonecrosis of the femoral head with a local application of recombinant human bFGF gelatin hydrogel for bone regeneration and preventing the femoral head collapse.
Date of disclosure of the study information 2012/11/02
Last modified on 2014/07/23

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Basic information
Public title The clinical trial investigating the safety in the treatment of osteonecrosis of the femoral head with a local application of recombinant human bFGF gelatin hydrogel for bone regeneration and preventing the femoral head collapse.
Acronym The clinical application of recombinant human bFGF gelatin hydrogel for osteonecrosis of the femoral head.
Scientific Title The clinical trial investigating the safety in the treatment of osteonecrosis of the femoral head with a local application of recombinant human bFGF gelatin hydrogel for bone regeneration and preventing the femoral head collapse.
Scientific Title:Acronym The clinical application of recombinant human bFGF gelatin hydrogel for osteonecrosis of the femoral head.
Region
Japan

Condition
Condition Osteonecrosis of the femoral head
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to evaluate the short-term safety in the treatment of osteonecrosis of the femoral head with a local application of recombinant human bFGF gelatin hydrogel.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Presence of adverse events
Key secondary outcomes Periodical assessment of clinical outcomes (VAS pain score, UCLA activity score, Harris Hip Score).
Radiological assessment of the stage of osteonecrosis and the repaired femoral head using MRI.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The local application of recombinant human bFGF gelatin hydrogel into the femoral head of osteonecrosis.
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients diagnosed with stage-1 or stage-2 osteonecrosis of the femoral head.
The affected femoral head of osteonecrosis can be considered suitable for the treatment with the local administration of bFGF gelatin hydrogel.
The adequate function of major organs is preserved.
Key exclusion criteria Patients with
Osteonecrosis of the femoral head who had been operated of the affected femoral head.
BMI over 30.
Serious complications including uncontrolled diabetes, serious hypertension, severe heart diseases and severe pulmonary diseases etc.
Malignancies treated within 5 years not including carcinoma in situ and intramucosal carcinoma.
Judged inappropriate with the reason for mental disorder or mental status by the treating physician
Active infection
Under treating diabetic retinopathy including preproliferative diabetic retinopathy and proliferative diabetic retinopathy.
Gelatin allergy
Drug allergy considered not to be suitable with this study.
receiving systemic corticosteroids over 10mg dosage of Prednisolone.
Target sample size 10

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Haruhiko Akiyama
Organization Kyoto University Hospital
Division name Department of Orthopedic Surgery
Zip code
Address 54 Kawahara-cho Shogoin Sakyo-ku Kyoto city
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization Kyoto University Hospital
Division name Department of Orthopedic Surgery
Zip code
Address
TEL 075-751-3360
Homepage URL
Email

Sponsor
Institute Department of Orthopedic Surgery, Kyoto University Hospital
Institute
Department

Funding Source
Organization Kyoto University Hospital
Organization
Division
Category of Funding Organization Other
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
2012 Year 11 Month 02 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
2012 Year 10 Month 11 Day
Date of IRB
Anticipated trial start date
2013 Year 03 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
2012 Year 11 Month 02 Day
Last modified on
2014 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010863

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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