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Study of the Safety and Effectiveness of DIAM™ Spinal Stabilization System Versus Conservative Care

NCT00456378 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 311

Last updated 2018-12-10

No results posted yet for this study

Summary

The purpose of this study is to establish the safety and effectiveness of the DIAM™ Spinal Stabilization System in the treatment of moderate single-level lumbar degenerative disc disease.

Conditions

  • Lumbar Degenerative Disc Disease

Interventions

DEVICE

DIAM™ Spinal Stabilization System

Surgical procedure with implantation of the Investigational device

PROCEDURE

Conservative care

Six months of conservative care, to include: patient education, medications, physical therapy and spinal injections.

Sponsors & Collaborators

  • Medtronic Spinal and Biologics

    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
2006-12-31
Primary Completion
2015-10-08
Completion
2018-11-20
FDA Device
Yes

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 NCT00456378 on ClinicalTrials.gov