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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004154
Receipt No. R000004937
Scientific Title The effect of large diameter head to prevent dislocation, and of 3 rd generation highly crosslinked polyethylene to reduce wear in computer assisted total hip arthroplasty
Date of disclosure of the study information 2010/09/03
Last modified on 2017/09/07

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Basic information
Public title The effect of large diameter head to prevent dislocation, and of 3 rd generation highly crosslinked polyethylene to reduce wear in computer assisted total hip arthroplasty
Acronym Navi & X3 Study
Scientific Title The effect of large diameter head to prevent dislocation, and of 3 rd generation highly crosslinked polyethylene to reduce wear in computer assisted total hip arthroplasty
Scientific Title:Acronym Navi & X3 Study
Region
Japan

Condition
Condition OA, AVN, RA, Fracture, and etc.
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1. To prove the efficacy of large diameter head in computer assisted total hip arthroplasty.
2. To prove the superiority of X3 acetabular liner on wear resistance.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Range of motion
2. Interannual behavior of wear
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. Patients are candidate for a primary THA with cementless acetabular and femoral components.
2. Patients have diagnosis of degenerative joint disease.
3. Patients are age 20 or over.
4. Patients, who agree on an IRB-approved, study specific Informed Patient Consent Form.
5. Patients are willing and able to comply with postoperative scheduled evaluations.
Key exclusion criteria 1. Patients have bacterial infectious disease or have risk highly of bacterial infection.
2. Patients requiring revision surgery of a previously implanted total hip arthroplasty.
3. Patients, who are morbidly obese, defined as having a Body Mass Index (BMI) > 40.
4. Patients who is pregnant female or maybe so.
5. Patients who have a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
6. Patients with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
7. Patients who are immunologically suppressed or receiving chronic steroids.
8. Patients who are judged ineligible with reasonable reason by primary doctor.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuko Komori
Organization Stryker Japan K.K.
Division name Clinical Affairs
Zip code
Address Iidabashi First Tower 30F, 2-6-1, Koraku, Bunkyo-ku, Tokyo
TEL 03-6894-8322
Email stryker_japan-com@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuko Komori
Organization Stryker Japan K.K.
Division name Clinical Affairs
Zip code
Address Iidabashi First Tower 30F
TEL 03-6894-8322
Homepage URL
Email stryker_japan-com@umin.ac.jp

Sponsor
Institute Stryker Japan K.K.
Institute
Department

Funding Source
Organization Stryker Japan K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 横浜市立大学附属病院(神奈川県)他

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 03 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
2010 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2016 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1. Analysis of ROM data.
2. Evaluation of wear rate by X-ray analysis.
3. Collection of adverse event (e.g. dislocation)

Management information
Registered date
2010 Year 09 Month 03 Day
Last modified on
2017 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004937

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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