A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis (FELIX)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|