ISRCTN88702314
Completed
未知
Cost effectiveness and quality of life after treatment of lumbar spinal stenosis with the X-STOP® Interspinous Process Distraction (IPD) device or laminectomy: a prospective randomised trial
niversity College London Hospitals NHS Foundation Trust (UK)0 sites47 target enrollmentJune 4, 2008
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity College London Hospitals NHS Foundation Trust (UK)
- Enrollment
- 47
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
2021 results in https://pubmed.ncbi.nlm.nih.gov/33530059/ (added 03/02/2021)
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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