A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis (FELIX)
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
Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis|
- Zurich Claudication Questionnaire (ZCQ) [ Time Frame: 5 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The EuroQol (EQ-5D) will be used for the cost utility analysis at the end of the investigation.
- MRDQ [ Time Frame: 5 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The McGill questionnaire measures the quality aspect of pain, next to the intensity of pain.
- VAS Leg Pain [ Time Frame: 5 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]Assessment of revisions, removals, re-operations, and major device-related complications.
- Radiographic Assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]Radiographic Assessment of coflex and control group
|Study Start Date:||October 2007|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Surgical decompression
Active Comparator: coflex Interlaminar Technology
Surgical decompression followed by implantation of coflex Interlaminar Technology.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727752
|Sint Lucas Andreas Ziekenhuis|
|Reinier De Graaf Gasthuis|
|Groene Hart Ziekenhuis|
|Medical Center Alkmaar|
|Leiden University Medical Center|
|The Hague, Netherlands|
|The Hague, Netherlands|
|Medical Center Haaglanden|
|The Hague/Leidschendam, Netherlands|