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OpenTrials
Completed

NCT Number: NCT05772143

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

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.

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Key information

Conditions

Lumbar Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de Nice

Nice, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous discectomies under CT

Procedure

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

Primary outcomes

  1. Oswestry disability index

    Time frame: before treatment

    Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders

  2. Oswestry disability index

    Time frame: At 1 month after treatment

    Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders

  3. Oswestry disability index

    Time frame: At 3 month after treatment

    Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders

  4. Oswestry disability index

    Time frame: At 6 month after treatment

    Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders

Secondary outcomes

  1. Visual analogic scale

    Time frame: Initially and at 1 month, 3 month and 6 month after the procedure

    pain rating scale from 0 to 10 (worst is 10)

  2. Off work duration

    Time frame: Initially and at 1 month, 3 month and 6 month after the procedure

    days before returning to work

  3. Hospitalization duration

    Time frame: Initially and at 1 month, 3 month and 6 month after the procedure

    overnights hospitalization stays following the intervention

  4. use of pain killers

    Time frame: Initially and at 1 month, 3 month and 6 month after the procedure

    frequency of the use of painkillers before and after the intervention

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 16, 2023
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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