A randomised blinded comparison of surgical intervention with the X STOPPK® interspinous process decompression versus surgical decompression for patients with intermittent neurogenic claudication caused by lumbar stenosis
Phase 4
Withdrawn
- Conditions
- Spinal stenosis & Pressure on the nerves causing leg pain1000595910043413
- Registration Number
- NL-OMON29809
- Lead Sponsor
- SFMT Europe BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 386
Inclusion Criteria
- signed informed consent
- is 18 - 80 years old at time of surgery
- has intermittent neurogenic claudication
- has received at least three months of conservative care therapy
Exclusion Criteria
- has cauda equina syndrome
- has Paget's disease, severe osteoporosis or metastasis to the vertebrae
- has had any surgery of the lumbar spine
- has severe comorbid conditions
- has any systemic disease that will interfere with the patient's welfare or outcome during the investigation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Symptoms and patient satisfaction will be measured with the Zurich Claudication<br /><br>Questionnaire.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The cost effectiveness as measured by the EuroQol questionnaire and costs<br /><br>obtained from the patient's diary.</p><br>