UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Yuko Komori
Organization	Stryker Japan K.K.
Division name	Clinical Affairs
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	Yuko Komori
Organization	Stryker Japan K.K.
Division name	Clinical Affairs
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 05 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000004937