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

  • STATUS
    Recruiting
  • End date
    Apr 28, 2023
  • participants needed
    24
  • sponsor
    University of Valencia
Updated on 27 January 2021

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.

Description

To implant a complete lumbar disc prosthesis removal of the anterior portion of the annulus fibrosus is required. It is known that the anterior portion of the annulus limits the movement in extension and axial rotation, so removal of this section of the annulus fibrosus will increase the range of movement in extension and axial rotation. As far as the investigators know, this increase in movement ranges has not been measured objectively in alive patients. Also the investigators would like to know if the postoperative prevertebral scar reduces an to what extent these abnormal movement ranges. This could help the investigators to decide when patients should be allowed to regain normal activities and specially, when the patients should be allowed to start working again. The investigators also aim to see if repairing intraoperatively the anterior portion of the annulus has any advantage in the final result achieved, and thus represents an improvement or not in the care of these patients

Details
Condition Lumbar Disc Disease
Treatment Anterior lumbar disc annulus removal versus replacement
Clinical Study IdentifierNCT04641039
SponsorUniversity of Valencia
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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 ability to follow the postoperative care program
Granting of informed consent

Exclusion Criteria

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
Previous lumbar spinal fracture
Mobile spondylolisthesis> 2 mm in translation and / or more than 11 angular difference with respect to the adjacent level on neutral vertical or flexion-extension radiographs
Severe osteoporosis
Spinal metastasis
Metabolic bone disease that could interfere with the implant or the surgical procedure
Rheumatoid arthritis, lupus, or other autoimmune disease that affects the musculoskeletal system
Other conditions or anatomical alterations that make the treatment of the anterior approach to the lumbar spine unfeasible
Known allergy to stainless steel, titanium or their alloys
Fixed or permanent neurological deficit
Active systemic infection at any time or ongoing preventive treatment for it, infection in the surgical site, HIV or hepatitis C
Abusive drug or alcohol use
Uncontrolled seizure disorder
Psychiatric illness that could interfere with your participation in the study
Participation in a current research study or in the 3 months prior to surgery
History of malignancy or current malignancy (except non-melanoma skin cancer), unless the patient has been treated for curative purposes and no clinical signs or symptoms have been observed for at least 5 years
Obesity (Body Mass Index or BMI> 35)
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