RecruitingNot Applicable

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

Spain24 participantsStarted 2020-11-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. * Absence in simple radiology studies of signs of vertebral instability or listhesis of the levels to be treated. * Absence of response for 6 weeks to conservative, non-surgical treatment, or presence of progressive symptoms. The treatment would also be carried out despite the absence of this study and the existence of the study does not condition in any way the treatment of the patients * Not having undergone any prior treatment of the type of microdiscectomy, laminectomy or lumbar arthrodesis, although these have been carried out at different levels than those involved on this occasion * Ability of the patient to comply with the proposed monitoring program * Patient's abil…

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
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Questions for the trial coordinator

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6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Range of spinal segment movement after lumbar disc prosthesis insertion in L4-L5 lumbar disc

Timeframe: One year

Trial details

NCT IDNCT04641039

SponsorUniversity of Valencia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12-28

Contact for this trial

Vicente Vanaclocha, MDPhD

+ 34 963 13 18 00 vivava@uv.es; vvanaclo@hotmail.com

View on ClinicalTrials.gov More Lumbar Disc Disease trials