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Clinical Trials/ISRCTN88702314
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)

Registry
who.int
Start Date
June 4, 2008
End Date
August 1, 2017
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity College London Hospitals NHS Foundation Trust (UK)

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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