Unique ID issued by UMIN | UMIN000031542 |
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Receipt number | R000031142 |
Scientific Title | The Effect of three-dimensional offset on abductor muscle and rotator muscles after total hip arthroplasty with Accolade II |
Date of disclosure of the study information | 2018/03/01 |
Last modified on | 2018/03/01 18:41:19 |
The Effect of three-dimensional offset on abductor muscle and rotator muscles after total hip arthroplasty with Accolade II
3D CT Offset Study
The Effect of three-dimensional offset on abductor muscle and rotator muscles after total hip arthroplasty with Accolade II
3D CT Offset Study
Japan |
Hip Osteoarthritis
Orthopedics |
Others
NO
To evaluate of three-dimensional offset with CT, to evaluate muscular strength on abductor muscle strength and rotator muscles
Safety,Efficacy
Confirmatory
Explanatory
Phase IV
muscle strength
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1)The subject requires a primary total hip arthroplasty.
2)The subject is 20 years of age and older
3)The subject is diagnosed as hip osteoarthritis.
4)The subject is planning to pre and post operative CT scan.
5)The subject has signed the IRB approved, study specific informed patient consent form.
6)The subject is willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation.
1)The subject is pregnant.
2)The subject has inflammatory arthritis.
3)The requires revision THA
4)The subject has femoral osteotomy and/or joint fusion
5)The subject is morbidly obese (BMI>=40)
6)The subject has a neuromuscular or neurosensory deficiency that would limit the ability to assess the performance of the device.
7)The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
8)The subject is immunologically suppressed or receiving steroids (>30 days) in excess of normal physiological requirements.
9)The subjects who are inappropriate for participating in the study in the judgment of the investigator.
150
1st name | |
Middle name | |
Last name | Mitsuyoshi Yamamura |
Osaka Rosai Hopital
orthopedics
1179-3 Nagasonecho, Kita-ku, Sakai, Osaka
072-252-3561
yamamura@abox22.so-net.ne.jp
1st name | |
Middle name | |
Last name | Emiko Suzuki |
Stryker
Clinical Affairs
2-6-1, Koraku,Bunkyo-ku, Tokyo
03-6894-8343
emiko.suzuki@stryker.com
Stryker
Stryker
Profit organization
NO
2018 | Year | 03 | Month | 01 | Day |
Unpublished
Open public recruiting
2017 | Year | 06 | Month | 05 | Day |
2018 | Year | 02 | Month | 20 | Day |
The aim of this study is to evaluate of three-dimensional offset with CT and muscular strength on abductor muscle strength and rotator muscles. This study is prospective, observational, single center and single arm.
2018 | Year | 03 | Month | 01 | Day |
2018 | Year | 03 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031142
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