UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009250 |
|---|---|
| Receipt number | 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 20:19:37 |
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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
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
Public contact
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
Sponsor or person
Institute
Department of Orthopedic Surgery, Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010863
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
