UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004154
Receipt number 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 16:02:15

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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 or person

Institute

Stryker Japan K.K.

Institute

Department

Personal name



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

Value
https://center6.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