Postoperative Scar in the Control Excess of Mobility Induced by Annulus Removal on Inserting a Lumbar Disc Prosthesis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Valencia

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Anterior lumbar disc annulus removal versus replacement

    Procedure/Surgery

    Owestry scale, SF12, Facet joint arthritis measured with Pathria scale, discal degeneration measured with Modic and Phirrmann scales

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Anterior annulus removalActive comparator 1 intervention
Group B: Anterior annulus replacementActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
One year

Secondary outcomes

Other outcomes

Sponsors and contacts

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