Cost-effectiveness of nerve root decompression according to Gill versus instrumented fusion in the treatment of spondylolytic spondylolisthesis; a multicenter prospective randomised trial.
Phase 4
Completed
- Conditions
- spondylolisthesisvertebra slipp off100059591004154310005944
- Registration Number
- NL-OMON31621
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 220
Inclusion Criteria
Age 18-70 years. Low grade spondylolytic spondylolisthesis (grade I or II). Sciatica or neurogenic claudication with/without backpain. Symptoms lasting more than 3 months. Informed consent.
Exclusion Criteria
High grade spondylolytic spondylolisthesis (grade III or IV). Backpain only. Progressive spondylolisthesis. Abnormal mobility on dynamic X-ray (> 3 mm). Previous lumbar surgery at level of spondylolisthesis. Severe comorbidity / contraindication surgery. Planned (e)migration in the year after surgery. Inadequate knowledge of Dutch language. Pregnancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure is an illness-specific 23 item functional<br /><br>assessment questionnaire; the Roland Disability Questionnaire for Sciatica.</p><br>
- Secondary Outcome Measures
Name Time Method