Lumbar ArthrodesisECALAPNCT04115202
Comparative Study of the Results of Anterior and Posterior Arthrodesis in Degenerative Lumbar Pathology
An observational study of Lumbar Arthrodesis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
To compare the functional results through the improvement of the Oswestry medium-term score of the lumbar arthrodesis performed to treat patients with lumbago and/or lumbar-radicular pain due to degenerative lesions of the lumbar spine: degenerative disc disease, osteoarthritis spondylolisthesis or adult dislocation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Arthrodesis
- What is being tested?
- lumbar arthrodesis
- Type of treatment
- Surgery or procedure
- How many people
- 254 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2018to 31 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with a degenerative lumbar pathology operated
Who may be able to join
- Patient requiring a lumbar arthrodesis to be carried out by one of the seven investigative surgeons of the Geoffroy Saint Hilaire Clinic IPAD study.
- At least 18 years old (no upper age limit).
- Patient with chronic lumbago or lumbar radiculopathy and resistant to a conservative medical treatment sufficiently carried out for at least 6 months, included alongside the usual analgesic, anti-inflammatory, infiltration and rehabilitation contraindications.
- Patient whose lumbar and/or radicular VAS is greater than or equal to 50 mm
- Patient whose Oswestry Index is greater than or equal to 40%
- Patient responding on one anatomical level* to one of the following diagnoses:
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- Spondylolisthesis or degenerative retrolisthesis or
- single stage dislocation on scoliosis or
- degenerative disc disease without true disc herniation, without deformity and instability reaching a single anatomical level
- *single-stage pathology located between L1 and the sacrum (1 stage = 2 vertebrae and an intervertebral disc).
- Patient with health insurance or beneficiary of a social security scheme
- Patient having been informed of and having agreed to the use of their health data (non-opposition)
Who cannot join
- - Any situation that is a contraindication to either surgical approach. For example, for the anterior approach: morbid obesity, a history of multiple abdomen surgical procedures, aneurysm of the operated abdominal aorta making retroperitoneal dissection dangerous, severe arteritis with risk of mobilisation of aortoiliac atheromatous plaque, previous radiotherapy (radiation in the path of the approach).
- Contraindication to the strategy under study or an act of evaluation: for example contraindication to imagery provided (Pace maker for MRI).
- Pathology located in L1L2 which against indicates the previous conventional approaches (need to disinsert the diaphragm).
- Patient with proven osteoporosis: femoral T-score > -2 SD (measurement of the lumbar spine is not relevant because disturbed by osteoarthritic phenomena with vertebral osteo-condensation) and imposing a circumferential arthrodesis: anterior and posterior.
- Patient with excluded disc herniation: hernia that cannot be removed by anterior route (NB: A simple hernia is not a non-inclusion criterion).
- Association with the single-stage pathology another lumbar lesion imposing to extend the act of arthrodesis and/or decompression to one or more spinal stages.
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- Any situation that could interfere with the follow-up of this study, i.e. psychological instability, personal situation hindering the follow-up of the study).
- Patient having undergone lumbar surgery less than one year ago
- Protected patients: adults under guardianship, trusteeship or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant, lactating or parturient women
- Individuals hospitalised without consent.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Geoffroy Saint Hilaire Clinic
Paris, IDF, 75005
Jean Francois OUDET, jeanfrancois.oudet@free.fr
Marie Barba, +330664888704 ext. +330664888704, mh.barba@ecten.eu
About this study
To compare the functional results through the improvement of the Oswestry medium-term score of the lumbar arthrodesis performed to treat patients with lumbago and/or lumbar-radicular pain due to degenerative lesions of the lumbar spine: degenerative disc disease, osteoarthritis spondylolisthesis or adult dislocation scoliosis.
Read the detailed description
Lower back pain is the leading cause of disability in France for adults under 45 years of age. It is also the leading cause of work stoppage and reported occupational illnesses. Thus, the degenerative pathologies of the lumbar spine can be at the origin of a severe handicap resistant to well-conducted medical treatment. This is particularly the case for degenerative disc disease, osteoarthritic spondylolisthesis and scoliotic dislocations in adults.
If lumbar arthrodesis is a recognised solution in the surgical treatment of degenerative diseases of the lumbar spine when they become disabling despite medical treatment, the choice of the operative technique and approach used to achieve it is more dependent of the training that the practitioner benefited from than the guidelines derived from published prospective comparative scientific studies comparing the results of different surgical solutions.
Our hypothesis is that the functional and radiographic results of anterior lumbar arthrodesis techniques by minimally invasive approach may differ from those of conventional posterolateral arthrodesis.
We propose to compare the results of these two surgical techniques within the orthopedic and neurosurgeon team of the Institut Parisien du Dos, mastering these two approaches optimally by leaving them free to use them as they do daily without modifying their procedures. This should allow us to judge, in a well-defined population, whether one of the two techniques is superior to the other when performed by surgeons who are experienced in this surgery.
- Conditions
- Lumbar Arthrodesis
- Being tested
- lumbar arthrodesis
- Medical subject headings
- Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar arthrodesisProcedure or surgery
two approaches anterior versus posterior, optimally by leaving physicians free to use them as they do daily without modifying their procedures
| Study group | Role | What they receive |
|---|---|---|
| posterior spinal approach group | Lumbar arthrodesis performed by a posterior spinal approach. Receives: Procedure: lumbar arthrodesis | |
| anterior spinal approach group | Lumbar arthrodesis performed by a anterior spinal approach. Receives: Procedure: lumbar arthrodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry medium-term score
The absolute value and improvement of the Oswestry score at 1 year compared to the preoperative score for the 2 populations of lumbar arthrodesis by anterior or posterior approach.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start31 May 2018
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar ArthrodesisStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Pr Jérome Allain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115202
- Sponsor's protocol ID
- 2017-A02319-44
- Acronym
- ECALAP
- Status last verified
- Oct 2019
- First submitted
- 2 Oct 2019
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Results of Anterior and Posterior Arthrodesis in Degenerative Lumbar Pathology
- ClinicalTrials.gov ID
- NCT04115202
- Acronym / sponsor ID
- ECALAP / 2017-A02319-44
- Conditions
- Lumbar Arthrodesis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Pr Jérome Allain
- Study start
- 31 May 2018 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 3 Oct 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.
To compare the functional results through the improvement of the Oswestry medium-term score of the lumbar arthrodesis performed to treat patients with lumbago and/or lumbar-radicular pain due to degenerative lesions of the lumbar spine: degenerative disc disease, osteoarthritis spondylolisthesis or adult dislocation scoliosis.
Detailed description
Lower back pain is the leading cause of disability in France for adults under 45 years of age. It is also the leading cause of work stoppage and reported occupational illnesses. Thus, the degenerative pathologies of the lumbar spine can be at the origin of a severe handicap resistant to well-conducted medical treatment. This is particularly the case for degenerative disc disease, osteoarthritic spondylolisthesis and scoliotic dislocations in adults.
If lumbar arthrodesis is a recognised solution in the surgical treatment of degenerative diseases of the lumbar spine when they become disabling despite medical treatment, the choice of the operative technique and approach used to achieve it is more dependent of the training that the practitioner benefited from than the guidelines derived from published prospective comparative scientific studies comparing the results of different surgical solutions.
Our hypothesis is that the functional and radiographic results of anterior lumbar arthrodesis techniques by minimally invasive approach may differ from those of conventional posterolateral arthrodesis.
We propose to compare the results of these two surgical techniques within the orthopedic and neurosurgeon team of the Institut Parisien du Dos, mastering these two approaches optimally by leaving them free to use them as they do daily without modifying their procedures. This should allow us to judge, in a well-defined population, whether one of the two techniques is superior to the other when performed by surgeons who are experienced in this surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| posterior spinal approach group | – | Procedure: lumbar arthrodesisLumbar arthrodesis performed by a posterior spinal approach. |
| anterior spinal approach group | – | Procedure: lumbar arthrodesisLumbar arthrodesis performed by a anterior spinal approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with a degenerative lumbar pathology operated
Key inclusion criteria (12 listed)
- Patient requiring a lumbar arthrodesis to be carried out by one of the seven investigative surgeons of the Geoffroy Saint Hilaire Clinic IPAD study.
- At least 18 years old (no upper age limit).
- Patient with chronic lumbago or lumbar radiculopathy and resistant to a conservative medical treatment sufficiently carried out for at least 6 months, included alongside the usual analgesic, anti-inflammatory, infiltration and rehabilitation contraindications.
- Patient whose lumbar and/or radicular VAS is greater than or equal to 50 mm
- Patient whose Oswestry Index is greater than or equal to 40%
Key exclusion criteria (11 listed)
- - Any situation that is a contraindication to either surgical approach. For example, for the anterior approach: morbid obesity, a history of multiple abdomen surgical procedures, aneurysm of the operated abdominal aorta making retroperitoneal dissection dangerous, severe arteritis with risk of mobilisation of aortoiliac atheromatous plaque, previous radiotherapy (radiation in the path of the approach).
- Contraindication to the strategy under study or an act of evaluation: for example contraindication to imagery provided (Pace maker for MRI).
- Pathology located in L1L2 which against indicates the previous conventional approaches (need to disinsert the diaphragm).
- Patient with proven osteoporosis: femoral T-score > -2 SD (measurement of the lumbar spine is not relevant because disturbed by osteoarthritic phenomena with vertebral osteo-condensation) and imposing a circumferential arthrodesis: anterior and posterior.
- Patient with excluded disc herniation: hernia that cannot be removed by anterior route (NB: A simple hernia is not a non-inclusion criterion).
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 arthrodesistwo approaches anterior versus posterior, optimally by leaving physicians free to use them as they do daily without modifying their procedures | Procedure or surgery | anterior spinal approach group, posterior spinal approach group |
Primary outcome
Oswestry medium-term score
Time frame: 12 months
The absolute value and improvement of the Oswestry score at 1 year compared to the preoperative score for the 2 populations of lumbar arthrodesis by anterior or posterior approach.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
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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 Lumbar Arthrodesis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 12 inclusion and 11 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 3 Oct 2019. 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 France. 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 Jean Francois OUDET (+33683346567, jeanfrancois.oudet@free.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry medium-term score (time frame: 12 months). 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 3 Oct 2019.