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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044215
Receipt No. R000050492
Scientific Title Pressure measurement during implant insertion in total hip arthroplasty
Date of disclosure of the study information 2021/06/01
Last modified on 2021/05/15

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Basic information
Public title Pressure measurement during implant insertion in total hip arthroplasty
Acronym Pressure measurement during implant insertion in total hip arthroplasty
Scientific Title Pressure measurement during implant insertion in total hip arthroplasty
Scientific Title:Acronym Pressure measurement during implant insertion in total hip arthroplasty
Region
Japan

Condition
Condition Osteoarthritis, osteonecrosis of the femoral head, rheumatoid arthritis, femoral neck fracture
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To measure the pressure between the acetabular and femoral components of hip arthroplasty.
Basic objectives2 Others
Basic objectives -Others To measure the pressure between the acetabular and femoral components of hip arthroplasty.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pressure between the acetabular and femoral components of hip arthroplasty
Key secondary outcomes

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

Not applicable
Gender Male and Female
Key inclusion criteria For patients who meet all of the following criteria
1) Patients with osteoarthritis of the hip and rheumatoid arthritis with narrowing of the joint space by plain X-ray, patients with osteonecrosis of the femoral head with collapse of the femoral head by plain X-ray, and femoral neck fracture patients.
2) Patients aged 20 years or older at the time of consent acquisition
3) Patients who received sufficient explanation before participating in this study, and after obtaining sufficient understanding, obtained written consent by the patient himself / herself.
4) Inpatients
Key exclusion criteria Patients who violate any of the following will not be included in this study
1) Patients with severe iliac deformity due to pelvic fracture, pelvic surgery, etc.
2) Women who are pregnant or may become pregnant
3) Lactating women
4) Patients who are judged by the principal investigator and the research coordinator to be inappropriate as research subjects
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Tomonori
Middle name
Last name Tetsunaga
Organization Okayama University Hospital
Division name Department of Orthopaedic Surgery
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kitaku, Okayama
TEL 0862357273
Email tomonori_t31@yahoo.co.jp

Public contact
Name of contact person
1st name Tomonori
Middle name Tetsunaga
Last name Tetsunaga
Organization Okayama University Hospital
Division name Department of Orthopaedic Surgery
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kitaku, Okayama
TEL 0862357273
Homepage URL
Email tomonori_t31@yahoo.co.jp

Sponsor
Institute Department of Orthopaedic Surgery, Okayama University Hospital
Institute
Department

Funding Source
Organization None
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 Okayama University Hospital
Address 2-5-1 Shikata-cho, Kitaku, Okayama
Tel 0862357273
Email tomonori_t31@yahoo.co.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
2021 Year 06 Month 01 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 Preinitiation
Date of protocol fixation
2021 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 06 Month 01 Day
Last follow-up date
2023 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A pressure sensor is placed between the acetabular and femoral components of hip replacement to measure the pressure applied between the implants.

Management information
Registered date
2021 Year 05 Month 15 Day
Last modified on
2021 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050492

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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