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Clinical Trials/NL-OMON36278
NL-OMON36278
Completed
Not Applicable

(Cost) Effectiveness of Surgery versus Prolonged Conservative Treatment in Patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis - The Verbiest Trial

eids Universitair Medisch Centrum0 sites280 target enrollmentTBD
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Conditionsintermittent neurogenic claudicationlumbar stenosis1004154310009720

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
intermittent neurogenic claudication
Sponsor
eids Universitair Medisch Centrum
Enrollment
280
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\-at least 50 years old
  • •\-at least 3 months intermittent neurogenic claudication, as noted by leg/buttock/groin pain with or without back pain or fatigue in the legs provoked by walking. Leg/buttock/groin pain or fatigue needs to be strongly relieved when flexed such as when sitting in a chair
  • •\-has a narrowed lumbar spinal canal, nerve root canal or intervertebral foramen at
  • •one or more levels confirmed by MRI
  • •\-has a regular indication for surgical intervention of INC
  • •\-informed consent

Exclusion Criteria

  • •\-has a cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (bladder retention or incontinence)
  • •\-has Paget\*s disease, severe osteoporosis or metastasis to the vertebrae
  • •\-has significant scoliosis (Cobb angle \> 25 degrees)
  • •\-has a Body Mass Index \> 40 kg/m2
  • •\-has previously had a laminectomy at the same level, has degenerative or lytic spondylolisthesis grade \>1 (on a scale 1 to 4\) at the affected level or has significant instability of the lumbar spine
  • •\-has severe comorbid conditions that will increase the risk to the patient or interfere with the evaluability of this study (e.g. severe ischemic heart disease, musculoskeletal or neurological conditions impairing walking ability, cognitive impairment (MMSE \<25 points)
  • •\-unable to read or write Dutch

Outcomes

Primary Outcomes

Not specified

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