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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
386
Sint Lucas Andreas Ziekenhuis
Amsterdam, Netherlands
Reinier De Graaf Gasthuis
Delft, Netherlands
Groene Hart Ziekenhuis
Gouda, Netherlands
Zurich Claudication Questionnaire (ZCQ)
ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.
Time frame: 5 years
EuroQOL (EQ-5D)
The EuroQol (EQ-5D) will be used for the cost utility analysis at the end of the investigation.
Time frame: 5 years
MRDQ
The 23-points MRDQ is the most widely used patient-assessed measure of health outcome for low back pain.
Time frame: 5 years
SF-36
The SF-36 questionnaire relates to the analysis of the general functional status and Quality of Life of patients.
Time frame: 5 years
McGill Pain Questionnaire
The McGill questionnaire measures the quality aspect of pain, next to the intensity of pain.
Time frame: 5 years
VAS Leg Pain
Improvement of the Visual Analog Scale (VAS) for leg pain (on the 100 mm scale) compared to control group
Time frame: 5 years
Re-operations, revisions, and major complications
Assessment of revisions, removals, re-operations, and major device-related complications.
Time frame: 5 years
Radiographic Assessment
Radiographic Assessment of coflex and control group
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Medical Center Alkmaar
Holland, Netherlands
Diaconessenhuis
Leiden, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Rijnland ziekenhuis,
Leiderdorp, Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Vlietland Ziekenhuis
Schiedam, Netherlands
Bronovo Ziekenhuis
The Hague, Netherlands
...and 3 more locations
Time frame: 12 months