Spots Global Cancer Trial Database for A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
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Trial Identification
Brief Title: A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
Official Title: A Prospective, Multicenter, Randomized, Open-label, Controlled Study to Evaluate the Safety and Efficacy of a Spine Fusion System in Vertebral Body Fusion Surgery
Study ID: NCT02252185
Study Description
Brief Summary: The primary objective of this study is to demonstrate that the efficacy and safety of Spine fusion system manufactured in China is no inferior than imported product.
Detailed Description: This study is a prospective, multicenter, randomized, comparative, non-inferiority study comparing the change of Japanese Orthopaedic Association Score from baseline at postoperative 24 weeks for patients implanted with local made Spine Fusion System versus imported products.
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
Anhui Province Hospital, Hefei, Anhui, China
Beijing Jishuitan Hospital, Beijing, Beijing, China
Henan Provincial People's Hospital, Zhengzhou, Henan, China
Jiangxi Provincial People's Hospital, Nanchang, Jiangxi, China
Shanghai Ruijin Hospital, Shanghai, Shanghai, China
Xijing Hospital, Xi'an, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University Medical College, Xi'an, Shanxi, China
The First Affiliated Hospital of Kunming Medical College, Kunming, Yunnan, China
Contact Details
Name: Wei Tian
Affiliation: Beijing Jishuitan Hospital
Role: PRINCIPAL_INVESTIGATOR
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