CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 165 enrolled
Drug / intervention
DIAM™ Spinal Stabilization System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00749996
NCT00749996Phase 4Completed
CompareCT.gov

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

Medtronic Spinal and Biologics·interventional·Posted Sep 10, 2008·Updated Jan 28, 2016

In Brief

A Phase 4 clinical trial evaluating DIAM™ Spinal Stabilization System and Herniectomy for Sciatica and Back Pain. Completed, enrolled 165 participants across 19 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSciatica, Back Pain
CountriesBelgium, Czechia, Germany, Italy, Poland, Spain, Switzerland, United Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 10, 2008
Enrollment StartNov 1, 2006
Primary CompletionApr 1, 2013
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 17.8 years ago

Interventions

DIAM™ Spinal Stabilization Systemdevice

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.

Herniectomyprocedure

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.