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Herniectomy Versus Herniectomy With a Spinal Stabilization System for the Treatment of Complex Disc Disease

NCT00749996 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2016-01-28

Study results available
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Summary

The study aims at assessing the short and long-term effectiveness and patient perception of benefit with the use of a DIAM™ Spinal Stabilization System in the treatment of complex disc disease at a single level from L2 to L5.

Conditions

Interventions

DEVICE

DIAM™ Spinal Stabilization System

The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach.

PROCEDURE

Herniectomy

Herniectomy is defined as the "removal of the extruded/protruded/sequestrated disc material". This is done by probing the annulus and disc space and removing all mobile disc fragments.

Sponsors & Collaborators

  • Medtronic Spinal and Biologics

    lead INDUSTRY

Principal Investigators

  • Ferdiand Krappel, Dr. · Spitalzentrum Oberwallis, Brig

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2013-04-30
Completion
2013-06-30

Countries

  • Belgium
  • Czechia
  • Germany
  • Italy
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00749996 on ClinicalTrials.gov