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

Lumbar Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05772143
• Other study ID #: 23Imagerie01
• Status: Completed
• Start date: December 1, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: October 31, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation

Intervention

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

Locations

Country	Name	City	State
France	Chu de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry disability index	Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders	before treatment
Primary	Oswestry disability index	Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders	At 1 month after treatment
Primary	Oswestry disability index	Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders	At 3 month after treatment
Primary	Oswestry disability index	Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders	At 6 month after treatment
Secondary	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
Secondary	Off work duration	days before returning to work	Initially and at 1 month, 3 month and 6 month after the procedure
Secondary	Hospitalization duration	overnights hospitalization stays following the intervention	Initially and at 1 month, 3 month and 6 month after the procedure
Secondary	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