A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02252185
Study type	Interventional
Source	Johnson & Johnson Medical (Suzhou) Ltd.
Contact
Status	Completed
Phase	N/A
Start date	July 2014
Completion date	December 2015

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