UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031542
Receipt No. R000031142
Scientific Title The Effect of three-dimensional offset on abductor muscle and rotator muscles after total hip arthroplasty with Accolade II
Date of disclosure of the study information 2018/03/01
Last modified on 2018/03/01

* 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 The Effect of three-dimensional offset on abductor muscle and rotator muscles after total hip arthroplasty with Accolade II
Acronym 3D CT Offset Study
Scientific Title The Effect of three-dimensional offset on abductor muscle and rotator muscles after total hip arthroplasty with Accolade II
Scientific Title:Acronym 3D CT Offset Study
Region
Japan

Condition
Condition Hip Osteoarthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate of three-dimensional offset with CT, to evaluate muscular strength on abductor muscle strength and rotator muscles
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes muscle strength
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 1)The subject requires a primary total hip arthroplasty.
2)The subject is 20 years of age and older
3)The subject is diagnosed as hip osteoarthritis.
4)The subject is planning to pre and post operative CT scan.
5)The subject has signed the IRB approved, study specific informed patient consent form.
6)The subject is willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation.
Key exclusion criteria 1)The subject is pregnant.
2)The subject has inflammatory arthritis.
3)The requires revision THA
4)The subject has femoral osteotomy and/or joint fusion
5)The subject is morbidly obese (BMI>=40)
6)The subject has a neuromuscular or neurosensory deficiency that would limit the ability to assess the performance of the device.
7)The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
8)The subject is immunologically suppressed or receiving steroids (>30 days) in excess of normal physiological requirements.
9)The subjects who are inappropriate for participating in the study in the judgment of the investigator.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuyoshi Yamamura
Organization Osaka Rosai Hopital
Division name orthopedics
Zip code
Address 1179-3 Nagasonecho, Kita-ku, Sakai, Osaka
TEL 072-252-3561
Email yamamura@abox22.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Emiko Suzuki
Organization Stryker
Division name Clinical Affairs
Zip code
Address 2-6-1, Koraku,Bunkyo-ku, Tokyo
TEL 03-6894-8343
Homepage URL
Email emiko.suzuki@stryker.com

Sponsor
Institute Stryker
Institute
Department

Funding Source
Organization Stryker
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 03 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 Open public recruiting
Date of protocol fixation
2017 Year 06 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The aim of this study is to evaluate of three-dimensional offset with CT and muscular strength on abductor muscle strength and rotator muscles. This study is prospective, observational, single center and single arm.

Management information
Registered date
2018 Year 03 Month 01 Day
Last modified on
2018 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031142

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.