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

NCT06555887 | Completed

• 1 other identifier: 29BRC20.0183 - ICASC
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Canal Stenosis

Outcome Measures

Primary Outcomes (1)

• characterize the evolution of functional capacity in patients undergoing anterior approach surgery for the management of symptomatic lumbar spinal stenosis

  Variation in Oswestry Desability Index (ODI) between pre-surgery and first assessment beyond 6 months post-surgery

  6 month

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Anterior surgery of central lumbar sténoses

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

Study Design

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

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 15, 2024
• Study Start: July 1, 2020
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three month and ending five years following the end study
• 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.

Locations

FR (1)