Spinal Approach for Lumbar Active Discopathy

NCT ID: NCT04086199

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2020-04-02

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,...)

Detailed Description

1) The Roland-Morris Disability Questionnaire

When your back hurts, you may find it difficult to do some of the things you normally do.

This list contains sentences that people have used to describe themselves when they have back pain. When you read them, you may find that some stand out because they describe you today.

As you read the list, think of yourself today. When you read a sentence that describes you today, put a tick against it. If the sentence does not describe you, then leave the space blank and go on to the next one. Remember, only tick the sentence if you are sure it describes you today.

1. I stay at home most of the time because of my back.

2. I change position frequently to try and get my back comfortable.

3. I walk more slowly than usual because of my back.

4. Because of my back I am not doing any of the jobs that I usually do around the house.

5. Because of my back, I use a handrail to get upstairs.

6. Because of my back, I lie down to rest more often.

7. Because of my back, I have to hold on to something to get out of an easy chair.

8. Because of my back, I try to get other people to do things for me.

9. I get dressed more slowly then usual because of my back.

10. I only stand for short periods of time because of my back.

11. Because of my back, I try not to bend or kneel down.

12. I find it difficult to get out of a chair because of my back.

13. My back is painful almost all the time.

14. I find it difficult to turn over in bed because of my back.

15. My appetite is not very good because of my back pain.

16. I have trouble putting on my socks (or stockings) because of the pain in my back.

17. I only walk short distances because of my back.

18. I sleep less well because of my back.

19. Because of my back pain, I get dressed with help from someone else.

20. I sit down for most of the day because of my back.

21. I avoid heavy jobs around the house because of my back.

22. Because of my back pain, I am more irritable and bad tempered with people than usual.

23. Because of my back, I go upstairs more slowly than usual.

24. I stay in bed most of the time because of my back.

Note to users:

This questionnaire is taken from: Roland MO, Morris RW. A study of the natural history of back pain. Part 1: Development of a reliable and sensitive measure of disability in low back pain. Spine 1983; 8: 141-144

The score of the RDQ is the total number of items checked - i.e. from a minimum of 0 to a maximum of 24.

It is acceptable to add boxes to indicate where patients should tick each item.

The questionnaire may be adapted for use on-line or by telephone.

2) Modified Macnab Criteria:

Excellent: No pain, No restriction of mobility, Return to normal work and level of activity

Good: Occasional nonradicular pain, Relief of presenting symptoms, Able to return to modified work

Fair: Some improved functional capacity, Still handicapped and/or unemployed

Poor: Continued objective symptoms of root involvement, Additional operative intervention needed at index level irrespective of length of postoperative follow-up

Conditions

Surgical Injury; Back Pain Lower Back Chronic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Anterior discectomy

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

Lumbar discectomy

Intervention Type: PROCEDURE

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

Posterior discectomy

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

Lumbar discectomy

Intervention Type: PROCEDURE

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

Interventions

Lumbar discectomy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JM Remacle, MD, Head of Neurosurgery Department, CHR Citadelle

UNKNOWN

Sponsor Role: collaborator

Vincent Bonhomme, MD, PhD, University Department of Anesthesia and Intensive Care Medicine, CHR Citadelle

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Régional de la Citadelle

OTHER

Sponsor Role: lead

Responsible Party

Remacle Thibault

MD, Resident in Neurosurgery Department, PhD Student University Of Liege, Belgium

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHR Citadelle

Liège, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Thibault Remacle, MD

Role: CONTACT

thibaultremacle@gmail.com

+3243217170 ext. +32473392971

Facility Contacts

Thibault Remacle, MD

Role: primary

Other Identifiers

Th Remacle

Identifier Type: -

Identifier Source: org_study_id