Spinal Approach for Lumbar Active Discopathy

NCT04086199 | Unknown

• 1 other identifier: Th Remacle
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to study the impact on different surgical approaches for lumbar active discopathy. This inflammatory disease of the disc and adjacent vertebral endplates can induce low back pain with inflammatory-like features. Lumbar fusion is proposed to the patient when conservative management is not enough. This fusion can be obtained by an anterior muscle sparring approach or by a posterior muscle decaying approach. The goal with this single center retrospective study is to identify the surgical approach that offers to the patient the better long term functional outcome. A phone call would allow us to ask patients a few questions:

• Mcnab's criteria
• Roland Morris Disability Questionnaire The patients medical file review would also allow us to identify:
• the length of hospital stay for the discectomy (in days)
• incidence of Failed Back Surgery Syndrome
• incidence of redo surgeries
• incidence of adjacent level diseases
• incidence of dural tears and eventual complications (meningitis, orthostatic headaches,...)
• incidence of iliac vessels injuries and eventual complications (thrombosis, need for revascularisation,...)

Conditions

Surgical Injury; Back Pain Lower Back Chronic

Outcome Measures

Primary Outcomes (1)

• Modified Macnab Criteria

  At the time of the phone call, up to 11 years after the surgery

Secondary Outcomes (3)

• The Roland-Morris Disability Questionnaire The Roland-Morris Disability Questionnaire The Roland-Morris Disability Questionnaire The Roland-Morris Disability Questionnaire

  At the time of the phone call, up to 11 years after the surgery

• Complications related to the surgery

  From date of surgery (lumbar discectomy) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months

• Length of hospital stay for the discectomy surgery

  From date of admission in the hospital for the surgery until the date of release from the hospital.

Study Arms (2)

Anterior discectomy

The discectomy is made by an anterior muscle sparring approach (extraperitoneal).

Procedure: Lumbar discectomy

Posterior discectomy

The discectomy is made by a posterior approach (posterior midline incision).

Procedure: Lumbar discectomy

Interventions

Lumbar discectomy PROCEDURE

Lumbar discectomy either by an anterior extraperitoneal approach or by a posterior midline approach.

Anterior discectomy; Posterior discectomy

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

Consecutive patients treated by lumbar discectomy for active discopathy in a single center, CHR Citadelle, by a single surgeon, Dr JM Remacle between 2009 and 2016.

You may qualify if:

• Patients suffering from lumbar active discopathy (MODIC 1, 2 or 3) with low back pain as dominant symptom and insufficiently relieved by conservative treatments

You may not qualify if:

• Irradiated leg pain as dominant symptom
• Acquired symptomatic spinal canal stenosis requiring decompression
• Previous lumbar surgeries

Sponsors & Collaborators

• Centre Hospitalier Régional de la Citadelle: lead
• JM Remacle, MD, Head of Neurosurgery Department, CHR Citadelle: collaborator
• Vincent Bonhomme, MD, PhD, University Department of Anesthesia and Intensive Care Medicine, CHR Citadelle: collaborator

Study Sites (1)

CHR Citadelle

Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Intraoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Thibault Remacle, MD

CONTACT

+3243217170; thibaultremacle@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Resident in Neurosurgery Department, PhD Student University Of Liege, Belgium

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 11, 2019
• Study Start: January 1, 2020
• Primary Completion: March 2, 2020
• Study Completion: April 2, 2020
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)