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

NCT02252185 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2015-12-03

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Johnson & Johnson Medical (Suzhou) Ltd.

    lead INDUSTRY

Principal Investigators

  • Wei Tian · Beijing Jishuitan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-09-30
Completion
2015-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02252185 on ClinicalTrials.gov