A Clinical Study of the Dynesys(R) Spinal System

Status Terminated

Clinical Trial Summary

This non-inferiority study will compare the clinical outcomes of subjects implanted with the Dynesys Spinal System versus the clinical outcomes of subjects implanted with an instrumented posterior lateral spinal fusion.

Clinical Trial Description

The purpose of this clinical study is to demonstrate the safety and effectiveness of the Dynesys Spinal System for patients requiring one or contiguous two-level posterior spinal stabilization of the lumbar, and/or sacral spine following decompression. The ability for this implant to maintain spinal alignment and non-fusion of spinal segments, while positively affecting clinical outcomes, will be assessed and compared to a posterior lateral spinal fusion (PLF) procedure using autogenous bone with a semi-rigid, polyaxial posterior spinal fixation system. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Degenerative Spondylolisthesis or Retrolisthesis
Spinal Stenosis
Spondylolisthesis
Stenosing Lesion.

Clinical Trial Details

NCT number	NCT00759057
Study type	Interventional
Source	Zimmer, Inc.
Contact
Status	Terminated
Phase	Phase 3
Start date	March 2003
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Withdrawn	`NCT03223701` - Efficacy of Using Solum IV and BMC With GFC in TLIF	Phase 4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
Terminated	`NCT00974623` - Bone Graft Materials Observational Registry	N/A
Completed	`NCT00996073` - Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion	Phase 2
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