UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021627 |
|---|---|
| Receipt number | R000024942 |
| Scientific Title | Prospective randomized comparison of clinical results between two types of intraoperative body position in total hip arthroplasty. |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2022/03/31 09:07:15 |
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Basic information
Public title
Prospective randomized comparison of clinical results between two types of intraoperative body position in total hip arthroplasty.
Acronym
Comparison of clinical results between two types of intraoperative body position in total hip arthroplasty.
Scientific Title
Prospective randomized comparison of clinical results between two types of intraoperative body position in total hip arthroplasty.
Scientific Title:Acronym
Comparison of clinical results between two types of intraoperative body position in total hip arthroplasty.
Region
| Japan |
Condition
Condition
Patients with unilateral total hip arthroplasty, osteoarthritis of the hip
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare clinical results between two types of intraoperative body position in total hip arthroplasty.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative clinical results
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
An unilateral total hip arthroplasty
Interventions/Control_2
The choice of two types of body position in total hip arthroplasty is randomized.
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
Patients receiving unilateral total hip arthroplasty.
Key exclusion criteria
Exclusion criteria of the patients are as follows.
(1) Patients lacking ability to agree or ability to express agreement for participation appropriately in this study.
(2) Severe contracture of the hip
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryohei |
| Middle name | |
| Last name | Takada |
Organization
Medical Hospital, Tokyo Medical and Dental University
Division name
Department of orthopedic surgery
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
0358035279
takada.orth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Ryohei |
| Middle name | |
| Last name | Takada |
Organization
Medical Hospital, Tokyo Medical and Dental University
Division name
Department of orthopedic surgery
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
0358035279
Homepage URL
takada.orth@tmd.ac.jp
Sponsor or person
Institute
Department of Orthopedic Surgery , Medical Hospital, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
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
Tokyo Medical and Dental University Hospital
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-3813-6111
takada.orth@tmd.ac.jp
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
| 2016 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
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
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2016 | Year | 03 | Month | 26 | Day |
Last modified on
| 2022 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024942
