A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis (FELIX)
|ClinicalTrials.gov Identifier: NCT01727752|
Recruitment Status : Completed
First Posted : November 16, 2012
Last Update Posted : March 31, 2016
|Condition or disease||Intervention/treatment||Phase|
|Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis||Procedure: Decompression||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||386 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Active Comparator: Surgical decompression
Active Comparator: coflex Interlaminar Technology
Surgical decompression followed by implantation of coflex Interlaminar Technology.
- Zurich Claudication Questionnaire (ZCQ) [ Time Frame: 5 years ]ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.
- EuroQOL (EQ-5D) [ Time Frame: 5 years ]The EuroQol (EQ-5D) will be used for the cost utility analysis at the end of the investigation.
- MRDQ [ Time Frame: 5 years ]The 23-points MRDQ is the most widely used patient-assessed measure of health outcome for low back pain.
- SF-36 [ Time Frame: 5 years ]The SF-36 questionnaire relates to the analysis of the general functional status and Quality of Life of patients.
- McGill Pain Questionnaire [ Time Frame: 5 years ]The McGill questionnaire measures the quality aspect of pain, next to the intensity of pain.
- VAS Leg Pain [ Time Frame: 5 years ]Improvement of the Visual Analog Scale (VAS) for leg pain (on the 100 mm scale) compared to control group
- Re-operations, revisions, and major complications [ Time Frame: 5 years ]Assessment of revisions, removals, re-operations, and major device-related complications.
- Radiographic Assessment [ Time Frame: 12 months ]Radiographic Assessment of coflex and control group
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727752
|Sint Lucas Andreas Ziekenhuis|
|Reinier De Graaf Gasthuis|
|Groene Hart Ziekenhuis|
|Medical Center Alkmaar|
|Leiden University Medical Center|
|Medical Center Haaglanden|
|The Hague/Leidschendam, Netherlands|
|The Hague, Netherlands|
|The Hague, Netherlands|