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

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT06290908` - RPE-P/TLIF for Lumbar Spinal Stenosis With Instability
Withdrawn	`NCT03223701` - Efficacy of Using Solum IV and BMC With GFC in TLIF	Phase 4
Recruiting	`NCT03883022` - Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery	N/A
Completed	`NCT02902380` - The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery	N/A
Not yet recruiting	`NCT06024785` - Vertebropexy - Randomized-controlled Trial	N/A
Not yet recruiting	`NCT06000319` - Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
Completed	`NCT02558621` - New Robotic Assistance System for Spinal Fusion Surgery	N/A
Completed	`NCT02454400` - Pre-surgery Physiotherapy for Patients With Specific Low Back Pain	N/A
Completed	`NCT01377623` - Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion	N/A
Completed	`NCT00996073` - Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion	Phase 2
Terminated	`NCT00974623` - Bone Graft Materials Observational Registry	N/A
Completed	`NCT00320619` - Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery	N/A
Completed	`NCT00022776` - Surgical Versus Nonsurgical Treatment for Spinal Stenosis	Phase 3
Completed	`NCT06060821` - Validity and Reliability of the 2-minute Step Test in Patients With Lumbar Spinal Stenosis
Recruiting	`NCT04552145` - Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis	N/A
Active, not recruiting	`NCT04379921` - Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch	N/A
Withdrawn	`NCT04315090` - Post-surgical Outcomes Measure Using the ERAS Protocol for Posterior Cervical Decompression and Fusion
Completed	`NCT04591249` - Physical Activity Intervention for Patients Following Lumbar Spine Surgery	N/A
Recruiting	`NCT04601363` - Personalized Spine Study Group (PSSG) Registry
Completed	`NCT04193488` - Mid-Transverse Process to Pleural (MTP) Block and Erector Spinal Plan (ESP) Block in Spinal Surgery	N/A