UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040374
Receipt No. R000046068
Scientific Title Comparison of periprosthetic bone remodeling following, bone morphology, and stem fixation of the fully hydroxyapatite coated stem in primary total hip arthroplasty. -A randomized controlled trial-
Date of disclosure of the study information 2020/07/01
Last modified on 2020/06/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Comparison of periprosthetic bone remodeling following, bone morphology, and stem fixation of the fully hydroxyapatite coated stem in primary total hip arthroplasty.
-A randomized controlled trial-
Acronym Comparison of two kinds of fully hydroxyapatite coated stem in primary total hip arthroplasty.
-A randomized controlled trial-
Scientific Title Comparison of periprosthetic bone remodeling following, bone morphology, and stem fixation of the fully hydroxyapatite coated stem in primary total hip arthroplasty.
-A randomized controlled trial-
Scientific Title:Acronym Comparison of periprosthetic bone remodeling following, bone morphology, and stem fixation of the fully hydroxyapatite coated stem in primary total hip arthroplasty.
-A randomized controlled trial-
Region
Japan

Condition
Condition osteoarthritis of the hip
osteonecrosis of the femoral head
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of periprosthetic bone remodeling following, bone morphology, and stem fixation between fully hydroxyapatite coated Polar stem and fully hydroxyapatite coated Avenir stem in primary total hip arthroplasty.
-A randomized controlled trial-

Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes periprosthetic bone remodeling following
Key secondary outcomes X-Ray examination
clinical results

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 fully hydroxyapatite coated stem (Polar stem)
Interventions/Control_2 fully hydroxyapatite coated stem (Avenir stm)
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
40 years-old <=
Age-upper limit
80 years-old >
Gender Female
Key inclusion criteria osteoarthritis of the hip
osteonecrosis of the hip
Key exclusion criteria revision surgery
severe osteoporosis
pregnant woman
lactating woman
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kazuo
Middle name
Last name Hirakawa
Organization Shonan Kamakura Joint Reconstruction Center
Division name Orthopaedic surgery
Zip code 247-0061
Address 5-4-17 Dai, Kamakura, Kanagawa
TEL 0467472377
Email mail@skjrc.jp

Public contact
Name of contact person
1st name Masahiko
Middle name
Last name Mihara
Organization Shonan Kamakura Joint Reconstruction Center
Division name Orthopaedic surgery
Zip code 247-0061
Address 5-4-17 Dai, Kamakura, Kanagawa
TEL 0467472377
Homepage URL
Email mail@skjrc.jp

Sponsor
Institute Shonan Kamakura Joint Reconstruction Center
Institute
Department

Funding Source
Organization Shonan Kamakura Joint Reconstruction Center
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 Mirai Iryo Research Center
Address 1-8-7, Koji-machi, Chiyoda-ku, Tokyo 102-0083, Japan
Tel 0332634801
Email mirai-ec1@mirai-iryo.com

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
2020 Year 07 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
2020 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2026 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 12 Day
Last modified on
2020 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046068

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.