Percutaneous Discectomy to Treat Symptomatic Lumbar Disc Herniation : Evaluation of Clinical Efficiency, Patient Reported Outcomes and Economical Impact by Assessing Time Before Return to Work and Duration of Hospitalization Stay

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

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 Overview

• Status: Completed
• Conditions: Lumbar Disc Herniation
• Intervention / Treatment: Procedure: Percutaneous discectomies under CT

• Study Type: Observational
• Enrollment (Actual): 87

Contacts and Locations

Study Locations

• France
  • Nice, France
    • Chu de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient over 18 years of age suffering from radiculalgia related to lumbar disc herniation visualized on MRI with radio-clinical concordance, failure of conservative treatment and nerve root infiltrations ; consulting in interventionnal radiology care unit,

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lumbar disc herniation; Patient over 18 years of age suffering from radiculalgia related to lumbar disc herniation visualized on MRI with radio-clinical concordance, failure of conservative treatment and nerve root infiltrations	Procedure: Percutaneous discectomies under CT; Percutaneous discectomies under CT guidance to treat lumbar disc herniations resistant to conservative treatment and nerve root infiltrations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry disability index	Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders	before treatment
Oswestry disability index	Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders	At 1 month after treatment
Oswestry disability index	Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders	At 3 month after treatment
Oswestry disability index	Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders	At 6 month after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogic scale	pain rating scale from 0 to 10 (worst is 10)	Initially and at 1 month, 3 month and 6 month after the procedure
Off work duration	days before returning to work	Initially and at 1 month, 3 month and 6 month after the procedure
Hospitalization duration	overnights hospitalization stays following the intervention	Initially and at 1 month, 3 month and 6 month after the procedure
use of pain killers	frequency of the use of painkillers before and after the intervention	Initially and at 1 month, 3 month and 6 month after the procedure

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: 23Imagerie01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not scheduled

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No