Surgical InjuryNCT04086199
Spinal Approach for Lumbar Active Discopathy
An observational study of Surgical Injury and Back Pain Lower Back Chronic, run by Centre Hospitalier Régional de la Citadelle at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Injury, Back Pain Lower Back Chronic
- What is being tested?
- Lumbar discectomy
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2020to 2 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients suffering from lumbar active discopathy (MODIC 1, 2 or 3) with low back pain as dominant symptom and insufficiently relieved by conservative treatments
Who cannot join
- Irradiated leg pain as dominant symptom
- Acquired symptomatic spinal canal stenosis requiring decompression
- Previous lumbar surgeries
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHR Citadelle
Liège, 4000
Thibault Remacle, MD
About this study
Official title: Discectomy for Lumbar Active Discopathy: Long Term Functional Outcome Comparison Between Anterior and Posterior Approach: A Retrospective Study
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:
Read more
- 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,...)
Read the detailed description
- 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.
- I stay at home most of the time because of my back.
- I change position frequently to try and get my back comfortable.
- I walk more slowly than usual because of my back.
- Because of my back I am not doing any of the jobs that I usually do around the house.
- Because of my back, I use a handrail to get upstairs.
- Because of my back, I lie down to rest more often.
- Because of my back, I have to hold on to something to get out of an easy chair.
- Because of my back, I try to get other people to do things for me.
- I get dressed more slowly then usual because of my back.
- I only stand for short periods of time because of my back.
- Because of my back, I try not to bend or kneel down.
- I find it difficult to get out of a chair because of my back.
- My back is painful almost all the time.
- I find it difficult to turn over in bed because of my back.
- My appetite is not very good because of my back pain.
- I have trouble putting on my socks (or stockings) because of the pain in my back.
- I only walk short distances because of my back.
- I sleep less well because of my back.
- Because of my back pain, I get dressed with help from someone else.
- I sit down for most of the day because of my back.
- I avoid heavy jobs around the house because of my back.
- Because of my back pain, I am more irritable and bad tempered with people than usual.
- Because of my back, I go upstairs more slowly than usual.
- 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.
- 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
- Being tested
- Lumbar discectomy
- Medical subject headings
- Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar discectomyProcedure or surgery
Lumbar discectomy either by an anterior extraperitoneal approach or by a posterior midline approach.
| Study group | Role | What they receive |
|---|---|---|
| Anterior discectomy | The discectomy is made by an anterior muscle sparring approach (extraperitoneal). Receives: Procedure: Lumbar discectomy | |
| Posterior discectomy | The discectomy is made by a posterior approach (posterior midline incision). Receives: Procedure: Lumbar discectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Macnab Criteria
Measured: 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
Measured: At the time of the phone call, up to 11 years after the surgery
Complications related to the surgery
Measured: 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
Measured: From date of admission in the hospital for the surgery until the date of release from the hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start1 Jan 2020
- Primary completion2 Mar 2020 (estimated)
- Study completion2 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional de la Citadelle
- Sponsor type
- University, hospital or other
- Collaborators
- JM Remacle, MD, Head of Neurosurgery Department, CHR Citadelle, Vincent Bonhomme, MD, PhD, University Department of Anesthesia and Intensive Care Medicine, CHR Citadelle
- Responsible party
- Principal investigator, Remacle Thibault, Centre Hospitalier Régional de la Citadelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086199
- Sponsor's protocol ID
- Th Remacle
- Status last verified
- Jan 2020
- First submitted
- 5 Sep 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discectomy for Lumbar Active Discopathy: Long Term Functional Outcome Comparison Between Anterior and Posterior Approach: A Retrospective Study
- ClinicalTrials.gov ID
- NCT04086199
- Acronym / sponsor ID
- Th Remacle
- Conditions
- Surgical Injury, Back Pain Lower Back Chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional de la CitadelleUniversity, hospital or other
- Collaborators
- JM Remacle, MD, Head of Neurosurgery Department, CHR Citadelle, Vincent Bonhomme, MD, PhD, University Department of Anesthesia and Intensive Care Medicine, CHR Citadelle
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 2 Mar 2020 (estimated)
- Study completion
- 2 Apr 2020 (estimated)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- I stay at home most of the time because of my back.
- I change position frequently to try and get my back comfortable.
- I walk more slowly than usual because of my back.
- Because of my back I am not doing any of the jobs that I usually do around the house.
- Because of my back, I use a handrail to get upstairs.
- Because of my back, I lie down to rest more often.
- Because of my back, I have to hold on to something to get out of an easy chair.
- Because of my back, I try to get other people to do things for me.
- I get dressed more slowly then usual because of my back.
- I only stand for short periods of time because of my back.
- Because of my back, I try not to bend or kneel down.
- I find it difficult to get out of a chair because of my back.
- My back is painful almost all the time.
- I find it difficult to turn over in bed because of my back.
- My appetite is not very good because of my back pain.
- I have trouble putting on my socks (or stockings) because of the pain in my back.
- I only walk short distances because of my back.
- I sleep less well because of my back.
- Because of my back pain, I get dressed with help from someone else.
- I sit down for most of the day because of my back.
- I avoid heavy jobs around the house because of my back.
- Because of my back pain, I am more irritable and bad tempered with people than usual.
- Because of my back, I go upstairs more slowly than usual.
- 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.
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior discectomy | – | Procedure: Lumbar discectomyThe discectomy is made by an anterior muscle sparring approach (extraperitoneal). |
| Posterior discectomy | – | Procedure: Lumbar discectomyThe discectomy is made by a posterior approach (posterior midline incision). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients suffering from lumbar active discopathy (MODIC 1, 2 or 3) with low back pain as dominant symptom and insufficiently relieved by conservative treatments
Key exclusion criteria (3 listed)
- Irradiated leg pain as dominant symptom
- Acquired symptomatic spinal canal stenosis requiring decompression
- Previous lumbar surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar discectomyLumbar discectomy either by an anterior extraperitoneal approach or by a posterior midline approach. | Procedure or surgery | Anterior discectomy, Posterior discectomy |
Primary outcome
Modified Macnab Criteria
Time frame: At the time of the phone call, up to 11 years after the surgery
3 secondary outcomes
The Roland-Morris Disability Questionnaire The Roland-Morris Disability Questionnaire The Roland-Morris Disability Questionnaire The Roland-Morris Disability Questionnaire
Time frame: At the time of the phone call, up to 11 years after the surgery
Complications related to the surgery
Time frame: 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
Time frame: From date of admission in the hospital for the surgery until the date of release from the hospital.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Injury and Back Pain Lower Back Chronic, run by Centre Hospitalier Régional de la Citadelle at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thibault Remacle, MD (+3243217170 ext. +32473392971, thibaultremacle@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Macnab Criteria (time frame: At the time of the phone call, up to 11 years after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.