Postoperative Scar in the Control Excess of Mobility Induced by Annulus Removal on Inserting a Lumbar Disc Prosthesis
NCT ID: NCT04641039
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2020-11-01
2026-12-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Anterior annulus removal
In these patients the anterior portion of the annulus fibrosus will be removed when inserting a complete lumbar disc prosthesis
Anterior lumbar disc annulus removal versus replacement
Owestry scale, SF12, Facet joint arthritis measured with Pathria scale, discal degeneration measured with Modic and Phirrmann scales
Anterior annulus replacement
In these group of patients the anterior portion of the annulus fibrosus will be opened up in to flaps hinged lateraly and replaced once the complete lumbar disc prosthesis is inserted
Anterior lumbar disc annulus removal versus replacement
Owestry scale, SF12, Facet joint arthritis measured with Pathria scale, discal degeneration measured with Modic and Phirrmann scales
Interventions
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Anterior lumbar disc annulus removal versus replacement
Owestry scale, SF12, Facet joint arthritis measured with Pathria scale, discal degeneration measured with Modic and Phirrmann scales
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
50 Years
ALL
No
Sponsors
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University of Valencia
OTHER
Responsible Party
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Vicente Vanaclocha
Profesor of Neurosurgery
Locations
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Hospital General Universitario de Valencia
Valencia, Valencia, Spain
Countries
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Central Contacts
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Vicente Vanaclocha, MDPhD
Role: CONTACT
Facility Contacts
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Vicente Vanaclocha, MDPhD
Role: primary
References
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Frelinghuysen P, Huang RC, Girardi FP, Cammisa FP Jr. Lumbar total disc replacement part I: rationale, biomechanics, and implant types. Orthop Clin North Am. 2005 Jul;36(3):293-9. doi: 10.1016/j.ocl.2005.02.014.
Auerbach JD, Jones KJ, Milby AH, Anakwenze OA, Balderston RA. Segmental contribution toward total lumbar range of motion in disc replacement and fusions: a comparison of operative and adjacent levels. Spine (Phila Pa 1976). 2009 Nov 1;34(23):2510-7. doi: 10.1097/BRS.0b013e3181af2622.
Huang YJ, Zhao SJ, Zhang Q, Nong LM, Xu NW. Comparison of lumbar pedicular dynamic stabilisation systems versus fusion for the treatment of lumbar degenerative disc disease: A meta-analysis. Acta Orthop Belg. 2017 Mar;83(1):180-193.
Other Identifiers
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101/2020
Identifier Type: -
Identifier Source: org_study_id
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