aminectomy or X-Stop – Which operation is more cost-effective for Lumbar Spinal Stenosis?
- Conditions
- eurogenic intermittent claudication secondary to lumbar spinal stenosisCirculatory SystemOther peripheral vascular diseases
- Registration Number
- ISRCTN88702314
- Lead Sponsor
- niversity College London Hospitals NHS Foundation Trust (UK)
- Brief Summary
2021 results in https://pubmed.ncbi.nlm.nih.gov/33530059/ (added 03/02/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 47
1. Age: 18-80
2. Sex: males and non-pregnant females
3. Chronic leg pain with or without back pain of greater than 6 months duration, partially or completely relieved by adopting flexed posture and who are suitable candidates for posterior lumbar surgery
4. Those who have completed at least 6 months of conservative treatment without obtaining adequate symptomatic relief
5. Degenerative changes at one or two adjacent levels between L1-S1 confirmed by X-ray, computerised tomography (CT) or magnetic resonance imaging (MRI) scan
1. Fixed motor deficit
2. Active infection or metastatic disease
3. Degenerative spondylolisthesis >= Meyerding Grade 2
4. Known allergy to implant materials
5. Severe osteoporosis or rheumatoid arthritis
6. Cauda equina syndrome
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cost of implanting X-stop interspinous distractor compared to conventional surgical decompression
- Secondary Outcome Measures
Name Time Method <br> The following will be assessed preoperatively, on discharge, at 6 weeks, 6, 12 and 24 months:<br> 1. Quality of life, assessed by the EQ-5D, 36-item Short Form health survey (SF-36) and Quebec Back Pain Disability Questionnaire<br> 2. Clinical efficacy, assessed by the Zucher Claudication Questionnaire (ZCQ), Oswestry Disability Index (ODI) and visual analogue scale (VAS)<br> 3. Safety (any complication either perioperatively or postoperatively)<br>