Anterior Discectomy Surgery With Arthrodesis in Degenerative Spinal Canal sténoses. (ICASC) (ICASC)

August 14, 2024 updated by: University Hospital, Brest

Anterior Discectomy Surgery With Arthrodesis in Degenerative Spinal Canal Stenoses: a Descriptive Pilot Study

Single-center retrospective study to characterize changes in the functional capacity of patients (change in Oswestry Desability Index (ODI)) undergoing anterior approach surgery for the management of symptomatic lumbar spinal stenosis between the pre-surgical period and the first assessment 6 months after surgery.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • CHRU de Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Anterior surgery of central lumbar sténoses

Description

Inclusion Criteria:

  • anterior surgical management (ALIF or LLIF)
  • symptomatic lumbar degenerative pathology (L1-L2 to L5-S1), objectified on MRI (Schizas B, C, D)
  • period from June 2017 to December 2019

Exclusion Criteria:

  • Traumatic sprains
  • History of decompression after the operated stage
  • Operated from a later time at the same time
  • Scolioses with Cobb angles greater than 10°
  • Patients under judicial protection
  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
characterize the evolution of functional capacity in patients undergoing anterior approach surgery for the management of symptomatic lumbar spinal stenosis
Time Frame: 6 month
Variation in Oswestry Desability Index (ODI) between pre-surgery and first assessment beyond 6 months post-surgery
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

October 31, 2020

Study Completion (Actual)

October 31, 2020

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 14, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 14, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC20.0183 - ICASC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning three month and ending five years following the end study

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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