Unique ID issued by UMIN | UMIN000021853 |
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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 |
Accolade II Multi-center Study on fixation pattern, contact point, between stem and cortical bone by CT image analysis
Accolade II CT Study
Accolade II Multi-center Study on fixation pattern, contact point, between stem and cortical bone by CT image analysis
Accolade II CT Study
Japan |
Hip osteoarthritis, osteonecrosis of the femoral head
Orthopedics |
Others
NO
To evaluate fixation pattern and contact point between stem and cortical bone by CT image analysis in order to verify the stem design concept.
Efficacy
Fixation pattern and contact point between stem and cortical bone
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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
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.
240
1st name | |
Middle name | |
Last name | Yuko Komori |
Stryker Japan K.K.
Clinical Affairs
2-6-1, Koraku, Bunkyo-ku, Tokyo, 112-0004
03-6894-0000
yuko.komori@stryker.com
1st name | |
Middle name | |
Last name | Kenta Suzuki |
Stryker Japan K.K.
Clinical Affairs
2-6-1, Koraku, Bunkyo-ku, Tokyo, 112-0004
03-6894-8357
kenta.suzuki@stryker.com
Stryker Japan K.K.
Stryker Japan K.K.
Profit organization
NO
2016 | Year | 04 | Month | 11 | Day |
Unpublished
Enrolling by invitation
2015 | Year | 07 | Month | 17 | Day |
2016 | Year | 04 | Month | 20 | Day |
N/A
2016 | Year | 04 | Month | 10 | Day |
2017 | Year | 09 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025200
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