Back Pain Lower Back Chronic Clinical Trial
Official title:
Discectomy for Lumbar Active Discopathy: Long Term Functional Outcome Comparison Between Anterior and Posterior Approach: A Retrospective Study
NCT number | NCT04086199 |
Other study ID # | Th Remacle |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2020 |
Est. completion date | April 2, 2020 |
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,...)
Status | Recruiting |
Enrollment | 160 |
Est. completion date | April 2, 2020 |
Est. primary completion date | March 2, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients suffering from lumbar active discopathy (MODIC 1, 2 or 3) with low back pain as dominant symptom and insufficiently relieved by conservative treatments Exclusion Criteria: - Irradiated leg pain as dominant symptom - Acquired symptomatic spinal canal stenosis requiring decompression - Previous lumbar surgeries |
Country | Name | City | State |
---|---|---|---|
Belgium | CHR Citadelle | Liège |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Régional de la Citadelle | JM Remacle, MD, Head of Neurosurgery Department, CHR Citadelle, Vincent Bonhomme, MD, PhD, University Department of Anesthesia and Intensive Care Medicine, CHR Citadelle |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Modified Macnab Criteria | At the time of the phone call, up to 11 years after the surgery | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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. |
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