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

NCT05772143 | Completed

• 1 other identifier: 23Imagerie01
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Visual analogic scale

  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

• Hospitalization 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

Study Arms (1)

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

Interventions

Percutaneous discectomies under CT PROCEDURE

Percutaneous discectomies under CT guidance to treat lumbar disc herniations resistant to conservative treatment and nerve root infiltrations.

Lumbar disc herniation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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,

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Chu de Nice

Nice, France

Location

Related Publications (1)

• Ranc PA, Rudel A, Bentellis I, Prestat A, Elbaze S, Sala V, Torre F, Pavan LJ, Uri IF, Amoretti N. Patient-Reported Outcomes and Return to Work after CT-Guided Percutaneous Lumbar Discectomy: A Prospective Study. J Vasc Interv Radiol. 2024 Mar;35(3):390-397. doi: 10.1016/j.jvir.2023.12.007. Epub 2023 Dec 16.

  PMID: 38110149 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 16, 2023
• Study Start: December 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: October 31, 2021
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)