UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038986 |
|---|---|
| Receipt number | R000044458 |
| Scientific Title | Patient reported outcome measures and quality of life assessment after rotational acetabular osteotomy |
| Date of disclosure of the study information | 2019/12/27 |
| Last modified on | 2022/06/27 13:06:02 |
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Basic information
Public title
Patient reported outcome measures and quality of life assessment after rotational acetabular osteotomy
Acronym
Patient reported outcome measures and quality of life assessment after rotational acetabular osteotomy
Scientific Title
Patient reported outcome measures and quality of life assessment after rotational acetabular osteotomy
Scientific Title:Acronym
Patient reported outcome measures and quality of life assessment after rotational acetabular osteotomy
Region
| Japan |
Condition
Condition
Acetabular dysplasia
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the outcomes after Rotational acetabular osteotomy using patient-reported outcome measures and quality of life assessment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient-reported outcome measures( at the timing of more than 2 years after surgery):
Japanese Orthopaedic Association Hip-Disease Evaluation Questionnaire (JHEQ)
EQ-5D
Key secondary outcomes
X-ray film, CT, MRI
Clinical outcomes: Harris hip score, JOA hip score
Sport activity
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who underwent rotational acetabular osteotomy(minimum of 2 years after surgery)
Key exclusion criteria
Patients who refuse to participate in this study
Unsuitable for this study as evaluated by the physician-in-charge
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Enishi |
Organization
Tokushima municipal hospital
Division name
Department of Rehabilitation Medicine
Zip code
7700812
Address
2-34 Kitajosanjima, Tokushima 7700812, Japan
TEL
0886225121
tetsuya-e@umin.org
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Enishi |
Organization
Tokushima Municipal Hospital
Division name
Department of Rehabilitation Medicine
Zip code
7700812
Address
2-34 Kitajosanjima, Tokushima 7700812, Japan
TEL
0886225121
Homepage URL
tetsuya-e@umin.org
Sponsor or person
Institute
Department of Rehabilitation Medicine, Tokushima Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushima Municipal Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushima Municipal Hospital
Address
2-34 Kitajosanjima, Tokushima 7700812, Japan
Tel
0886225121
tetsuya-e@umin.org
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
Tokushima Municipal Hospital
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 27 | 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
| 2019 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 29 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data will be obtained from medical record.
Management information
Registered date
| 2019 | Year | 12 | Month | 25 | Day |
Last modified on
| 2022 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044458
