About this trial
To implant a complete lumbar disc prosthesis removal of the anterior portion of the annulus fibrosus is required. As the anterior portion of the annulus limits the movement in extension and axial rotation, we would like to know how much increase these two disc movements and also the effect on the postoperative prevertebral scar on the reduction of these abnormal movement ranges. We also aim to see if repairing intraoperatively the anterior portion of the annulus has any advantage in the final result achieved.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Minimum age of 18 years and maximum of 50 years, given that above that age there is usually degenerative pathology of the lumbar joint facets, which can confuse the symptoms and make it difficult to interpret the results.
Pathology compatible with chronic low back pain accompanied or not by radiculopathy originating in one or a maximum of two degenerated intervertebral discs and without signs of degeneration / osteoarthritis of the lumbar joint facets.
The type of lumbar pain must be discogenic, that is, worsen in flexion and not in extension, and in loading, as well as having a truncal distribution with possible anterior radiation towards the English or genital region.
Radiological confirmation by lumbar MRI study of lumbar discopathy of one or a maximum of two lumbar levels.
Disqualifiers
Signs of arthropathy of the lumbar joint facets, osteoporosis, previous interventions on the lumbar spine
Deformity or instability of the lumbar spine
Lumbar canal stenosis
Previous intervention on lumbar spine
Trial design
Parallel
Treatments tested in this trial
Anterior lumbar disc annulus removal versus replacement
Procedure/SurgeryOwestry scale, SF12, Facet joint arthritis measured with Pathria scale, discal degeneration measured with Modic and Phirrmann scales
Treatment groups
Trial outcomes
Primary outcomes
Range of spinal segment movement after lumbar disc prosthesis insertion in L4-L5 lumbar disc
The investigators will analyze preoperatively and postoperatively at 3, 6 and 12 months the range of movement of the L4-L5 lumbar disc after insertion of a complete lumbar disc prosthesis
Sponsors and contacts
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