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Clinical Trials/NCT05772143
NCT05772143CompletedNot Applicable

Percutaneous Lumbar Discectomy : Evaluation of Patient Reported Outcomes, Aconomical Impact and Return to Work

Centre Hospitalier Universitaire de Nice1 site in 1 country87 target enrollmentStarted: December 1, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
87
Locations
1
Primary Endpoint
Oswestry disability index
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study aims to evaluate the clinical (pain) and functional (patient reported outcomes) efficacy of percutaneous discectomies under CT guidance to treat lumbar disc herniations resistant to conservative treatment and nerve root infiltrations.

The aim is also to evaluate the economic impact of the procedure, mainly through the length of hospitalization and the time to return to work.

Patients were evaluated initially before surgery and then at 1, 3 and 6 months.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •radiculalgia related to lumbar disc herniation with clinical radiological concordance
  • •age > 18
  • •resistance to conservative treatment and nerve root infiltrations

Exclusion Criteria

  • •prior discal surgery at the same level,
  • •lumbar canal stenosis,
  • •extruded discal herniation,
  • •neurological deficit,
  • •no capacity to answer to follow-up calls

Outcomes

Primary Outcomes

Oswestry disability index

Time Frame: At 6 month after treatment

Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders

Secondary Outcomes

  • Visual analogic scale(Initially and at 1 month, 3 month and 6 month after the procedure)
  • Hospitalization duration(Initially and at 1 month, 3 month and 6 month after the procedure)
  • Off work duration(Initially and at 1 month, 3 month and 6 month after the procedure)
  • use of pain killers(Initially and at 1 month, 3 month and 6 month after the procedure)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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