NCT04641039 Postoperative Scar in the Control Excess of Mobility Induced by Annulus Removal on Inserting a Lumbar Disc Prosthesis
| NCT ID | NCT04641039 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Valencia |
| Condition | Lumbar Disc Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2020-11-01 |
| Primary Completion | 2029-12-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2020-11-01 with a primary completion date of 2029-12-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04641039 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Lumbar Disc Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04641039 currently recruiting?
Yes, NCT04641039 is actively recruiting participants. Contact the research team at vivava@uv.es; vvanaclo@hotmail.com for enrollment information.
Where is the NCT04641039 trial being conducted?
This trial is being conducted at Valencia, Spain.
Who is sponsoring the NCT04641039 clinical trial?
NCT04641039 is sponsored by University of Valencia. The trial plans to enroll 24 participants.