Discussion on Clinical Trial Design of Artificial Hip Prosthesis.
10.3969/j.issn.1671-7104.2018.04.009
- Author:
Jiazhen ZHANG
1
;
Bin LIU
1
;
Bao ZHAI
1
;
Yue MIN
1
;
Yinghui LIU
1
;
Shiqing ZHANG
1
Author Information
1. Center for Medical Device Evaluation, CFDA, Beijing,
- Publication Type:Journal Article
- Keywords:
artificial hip prosthesis;
clinical trial design;
evaluation standard;
sample size
- MeSH:
Arthroplasty, Replacement, Hip;
Clinical Trials as Topic;
Hip Prosthesis;
Prosthesis Design;
Registries;
Treatment Outcome
- From:
Chinese Journal of Medical Instrumentation
2018;42(4):262-264
- CountryChina
- Language:Chinese
-
Abstract:
Recently, the registration of artificial hip prosthesis products increased year by year. In the new version of the provisions for medical device registration, the domestic or import of such products in the registration declaration may need to complete a clinical trial in the country. How to carry out scientific clinical trials of the product design is the common concern of enterprises and clinical trial institutions. To review the guideline and literature concerning registration for artificial hip prosthesis, the focus on clinical trial design of artificial hip prosthesis include clinical inclusion, evaluation standard, sample size. Through the discussion, we hope to provide advice and guidance for clinical trials of this kind of products.
