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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
interventional device is Spine Fusion System that is manufactured by Johnson \& Johnson Medical Suzhou Ltd.
Comparator in this study is active comparator.
Anhui Province Hospital
Hefei, Anhui, China
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Change of Japanese Orthopaedic Association score
Questionnaire
Time frame: Preoperation and 24week post operation
Improvement rate of Japanese Orthopaedic Association score
Questionnaire
Time frame: 7day, 12week, and 24week post operation
Fixation stability
Fixation stability should be measured based on translational motion and angular motion which is demonstrated on X-Ray examination (A/P lateral, Flexion and extension).
Time frame: 12week, and 24week post operation
Visual Analogue Score of low back and leg pain
Visual Analogue Scale
Time frame: 7day, 12week, and 24week post operation
Wound healing
would healing are classified as 3 classes. (Class I, Class II, Class III)
Time frame: 7day, 12week, and 24week post operation
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Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, 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