Spinal Approach for Lumbar Active Discopathy

January 21, 2020 updated by: Remacle Thibault, Centre Hospitalier Régional de la Citadelle

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:

  • 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,...)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • Recruiting
        • CHR Citadelle
        • Contact:
          • Thibault Remacle, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Anterior discectomy
The discectomy is made by an anterior muscle sparring approach (extraperitoneal).
Procedure: Lumbar discectomy
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).
Procedure: Lumbar discectomy
Lumbar discectomy either by an anterior extraperitoneal approach or by a posterior midline approach.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Modified Macnab Criteria
Time Frame: At the time of the phone call, up to 11 years after the surgery
At the time of the phone call, up to 11 years after the surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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.
From date of admission in the hospital for the surgery until the date of release from the hospital.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Régional de la Citadelle

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
JM Remacle, MD, Head of Neurosurgery Department, CHR Citadelle
Vincent Bonhomme, MD, PhD, University Department of Anesthesia and Intensive Care Medicine, CHR Citadelle

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 2, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 2, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Th Remacle

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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