NCT02252185

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

A Prospective, Multicenter, Randomized, Open-label, Controlled Study to Evaluate the Safety and Efficacy of a Spine Fusion System in Vertebral Body Fusion Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Johnson & Johnson Medical (Suzhou) Ltd. · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Disc Degenerative Disease
• Spondylolisthesis
• Spinal Fracture
• Spinal Deformity
• Spinal Stenosis
• Spinal Tumor

Interventions

Type	Name	Description
DEVICE	Johnson&Johnson Medical Suzhou made Spine Fusion System	interventional device is Spine Fusion System that is manufactured by Johnson \& Johnson Medical Suzhou Ltd.
DEVICE	Imported EXPEDIUM screws and OPAL cage	Comparator in this study is active comparator.

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-09-01
• Completion: 2015-12-01
• First posted: 2014-09-30
• Last updated: 2015-12-03

Locations

8 sites across 1 country: China