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Percutaneous Dynamic Stabilization (PDS) System Versus Fusion for Treating Degenerative Disc Disease

NCT00878579 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-02-21

No results posted yet for this study

Summary

The objective of this study is to evaluate the safety and effectiveness of the PDS System compared to the surgical control of posterolateral fusion with autograft and pedicle screw fixation for the treatment of one or two levels from L3-S1 to relieve back pain associated with degenerative disc disease.

Conditions

  • Lumbar Degenerative Disc Disease

Interventions

DEVICE

PDS System

Percutaneous Dynamic Stabilization System

DEVICE

Fusion

Transforaminal Interbody Fusion (TLIF) with Autograft and Pedicle Screws

Sponsors & Collaborators

  • Interventional Spine, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

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 NCT00878579 on ClinicalTrials.gov