Status:
UNKNOWN
Comparative Study of the Results of Anterior and Posterior Arthrodesis in Degenerative Lumbar Pathology
Lead Sponsor:
Ramsay Générale de Santé
Collaborating Sponsors:
Pr Jérome Allain
Conditions:
Lumbar Arthrodesis
Eligibility:
All Genders
18+ years
Brief 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 degen...
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- \- 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.
Key Trial Info
Start Date :
May 31 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2020
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT04115202
Start Date
May 31 2018
End Date
July 31 2020
Last Update
October 3 2019
Active Locations (1)
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1
Geoffroy Saint Hilaire Clinic
Paris, IDF, France, 75005