NCT00749996

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Medtronic Spinal and Biologics · Industry
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a multi-center, prospective, randomized, controlled trial. Patients will be randomized in 2 groups: Investigational group: a single level herniectomy procedure, followed by placement of the DIAMTM Spinal Stabilization System; Control group: a single level herniectomy procedure; After surgery, patients will be followed for a 2 years period with required follow up visits at 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years (optional visit).

Conditions

• Sciatica
• Back Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-11-01
• Primary completion: 2013-04-01
• Completion: 2013-06-01
• First posted: 2008-09-10
• Last updated: 2016-01-28
• Results posted: 2014-05-23

Locations

19 sites across 8 countries: Belgium, Czechia, Germany, Italy, Poland, Spain, Switzerland, United Kingdom