Neurogenic intermittent claudication secondary to lumbar spinal stenosis Circulatory System Other peripheral vascular diseases
Conditions
Interventions
Participants will be randomly allocated to the one of two treatment groups. A five block randomisation process will be used and patients are randomised the day before surgery.
Lumbar
Sponsors
University College London Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cost of implanting X-stop interspinous distractor compared to conventional surgical decompression | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be assessed preoperatively, on discharge, at 6 weeks, 6, 12 and 24 months: 1. Quality of life, assessed by the EQ-5D, 36-item Short Form health survey (SF-36) and Quebec Back Pain Disability Questionnaire 2. Clinical efficacy, assessed by the Zucher Claudication Questionnaire (ZCQ), Oswestry Disability Index (ODI) and visual analogue scale (VAS) 3. Safety (any complication either perioperatively or postoperatively) | — |
Countries
United Kingdom
Outcome results
None listed