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DIAM™ Spinal Stabilization System vs. Decompression, Formerly vs. Posterolateral Fusion

NCT00627497 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-01-05

Study results available
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Summary

The purpose of this clinical trial is to evaluate the safety and effectiveness of the DIAM Spinal Stabilization System as a method of treating patients with symptoms of degenerative lumbar spinal stenosis at a single level from L2 to L5.

Conditions

  • Degenerative Lumbar Spinal Stenosis

Interventions

PROCEDURE

Single-Level Posterior Decompression

The single level posterior decompression is a posterior surgical procedure.

DEVICE

DIAM Spinal Stabilization

The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach.

DEVICE

DIAM Spinal Stabilization

The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach

DEVICE

Fusion

Posterolateral Interbody Fusion

Sponsors & Collaborators

  • Medtronic Spinal and Biologics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-12-31
Completion
2010-12-31

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 NCT00627497 on ClinicalTrials.gov