NCT01727752

A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 386 (actual)
• Sponsor: Paradigm Spine · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, Blinded Comparison of Surgical Intervention with the Coflex® Interspinous Implant versus Surgical Decompression for Patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis

Detailed description

In this investigation, it will be investigated whether the effectiveness of surgical intervention with Coflex® is equivalent to surgical decompression after 12 months in people with intermittent claudication. The main advantage of coflex® might be a faster recovery after surgery, but after long term follow-up it is unknown if this treatment effect remains. Therefore in addition, it will be investigated whether surgical intervention with coflex® is more effective than surgical decompression on short-term follow-up (8 weeks to 6 months) and whether surgical intervention with coflex® is more cost-effective after 12 months than surgical decompression.

Conditions

• Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis

Interventions

Type	Name	Description
PROCEDURE	Decompression

Timeline

• Start date: 2007-10-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2012-11-16
• Last updated: 2016-03-31

Locations

13 sites across 1 country: Netherlands