Spinal Approach for Lumbar Active Discopathy

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04086199
• Other study ID #: Th Remacle
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: April 2, 2020

Study information

• Verified date: January 2020
• Source: Centre Hospitalier Régional de la Citadelle
• Contact: Thibault Remacle, MD
• Phone: +3243217170
• Email: thibaultremacle[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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,...)

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Back Pain
• Back Pain Lower Back Chronic
• Intraoperative Complications
• Surgical Injury

Intervention

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

Locations

Country	Name	City	State
Belgium	CHR Citadelle	Liège

Sponsors (3)

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

Country where clinical trial is conducted

Belgium, 

Outcome

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.