A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis
NCT01727752 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 386
Last updated 2016-03-31
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
Conditions
- Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis
Interventions
- PROCEDURE
-
Decompression
Sponsors & Collaborators
-
Paradigm Spine
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-10-31
- Primary Completion
- 2015-06-30
- Completion
- 2015-06-30
Countries
- Netherlands
Study Locations
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