Informations générales (source: ClinicalTrials.gov)
Comparative Study of the Results of Anterior and Posterior Arthrodesis in Degenerative Lumbar Pathology
Observational
Ramsay Générale de Santé (Voir sur ClinicalTrials)
mai 2018
juillet 2020
13 août 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLINIQUE GEOFFROY SAINT HILAIRE | Jean Francois OUDET | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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:
- 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)
- 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:
- 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)
-
- 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.
- 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.