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A Clinical Study of the Dynesys(R) Spinal System

NCT00759057 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 399

Last updated 2012-06-28

No results posted yet for this study

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.

Conditions

  • Degenerative Spondylolisthesis or Retrolisthesis
  • Spinal Stenosis
  • Stenosing Lesion.

Interventions

DEVICE

Posterior Pedicle Screw System

Implantation of Posterior Pedicle Screw System

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2015-06-30
Completion
2015-12-31

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 NCT00759057 on ClinicalTrials.gov