UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Accolade II Multi-center Study on fixation pattern, contact point, between stem and cortical bone by CT image analysis
Title of the study (Brief title)	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	Yuko Komori
Organization	Stryker Japan K.K.
Division name	Clinical Affairs
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	Kenta Suzuki
Organization	Stryker Japan K.K.
Division name	Clinical Affairs
Address	2-6-1, Koraku, Bunkyo-ku, Tokyo, 112-0004
TEL	03-6894-8357
Homepage URL
Email	kenta.suzuki@stryker.com

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

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

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 11 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 07 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025200