UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021853
Receipt number R000025200
Scientific Title Accolade II Multi-center Study on fixation pattern, contact point, between stem and cortical bone by CT image analysis
Date of disclosure of the study information 2016/04/11
Last modified on 2017/09/07 16:03:16

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Basic information

Public title

Accolade II Multi-center Study on fixation pattern, contact point, between stem and cortical bone by CT image analysis

Acronym

Accolade II CT Study

Scientific Title

Accolade II Multi-center Study on fixation pattern, contact point, between stem and cortical bone by CT image analysis

Scientific Title:Acronym

Accolade II CT Study

Region

Japan


Condition

Condition

Hip osteoarthritis, osteonecrosis of the femoral head

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate fixation pattern and contact point between stem and cortical bone by CT image analysis in order to verify the stem design concept.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Fixation pattern and contact point between stem and cortical bone

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.
2) Patients are collected CT image postoperatively.
3) Patients have diagnosis of OA, AVN.
4) Patients are age 20 or over.
5) Patients, who agree on an IRB-approved, study specific Informed Patient Consent Form
6) 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

240


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

2-6-1, Koraku, Bunkyo-ku, Tokyo, 112-0004

TEL

03-6894-0000

Email

yuko.komori@stryker.com


Public contact

Name of contact person

1st name
Middle name
Last name Kenta Suzuki

Organization

Stryker Japan K.K.

Division name

Clinical Affairs

Zip code


Address

2-6-1, Koraku, Bunkyo-ku, Tokyo, 112-0004

TEL

03-6894-8357

Homepage URL


Email

kenta.suzuki@stryker.com


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



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

2016 Year 04 Month 11 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

Enrolling by invitation

Date of protocol fixation

2015 Year 07 Month 17 Day

Date of IRB


Anticipated trial start date

2016 Year 04 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

N/A


Management information

Registered date

2016 Year 04 Month 10 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=R000025200


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name