UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018394 |
|---|---|
| Receipt number | R000020395 |
| Scientific Title | Hip osteotomy of the osteonecrosis of the femoral head with reconstructing collapsed lesion |
| Date of disclosure of the study information | 2015/07/23 |
| Last modified on | 2019/04/02 16:15:04 |
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Basic information
Public title
Hip osteotomy of the osteonecrosis of the femoral head with reconstructing collapsed lesion
Acronym
Reconstruction of collapsed lesion of the osteonecrosis of the femoral head
Scientific Title
Hip osteotomy of the osteonecrosis of the femoral head with reconstructing collapsed lesion
Scientific Title:Acronym
Reconstruction of collapsed lesion of the 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
To prevent either progressive collapse of the femoral head or joint space narrowing by joint preserving surgery for the osteonecrosis of the femoral head with reconstruction of the collapsed lesion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Appearance of either progressive collapse of the femoral head or joint space narrowing on radiographs performed every one year after the operation.
Key secondary outcomes
Clinical and functional hip score examined every one year after the operation.
Safety of operation
Adverse event of artificial bone material
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
| Maneuver | Other |
Interventions/Control_1
To use artificial bone material for reconstructing collapsed lesion of the femoral head.
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
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Objectives have been diagnosed as the osteonecrosis of the femoral head based on the classification system of the Japanese Investigation Committee of Health and Welfare.
(2)Objectives have been classified into stage 3 on MRI and radiographs, which means that the femoral head was collapsed.
(3)Objectives are 20 years of age or older
(4)Objectives are 55 years of age or under
(5)Objectives have consented to participate in the study after fully informed.
Key exclusion criteria
The objectives that principal attending doctor considered unlikely to improve sufficiently or unsuitable for the entry to the trial.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Goro Motomura |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Orthopaedic Surgery
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5488
goromoto@ortho.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Goro Motomura |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Orthopaedic Surgery
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5488
Homepage URL
goromoto@ortho.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Nothing in particular
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
九州大学病院(福岡県)
Graduate School of Medical Sciences, Kyushu University(Fukuoka)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 23 | 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
100
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
Terminated
Date of protocol fixation
| 2015 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 23 | Day |
Last modified on
| 2019 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020395
