Evaluating the effects of lumbar disc prosthesis surgery on movement and scarring

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of removing the anterior portion of the annulus fibrosus during lumbar disc prosthesis implantation on the range of movement in extension and axial rotation. It aims to objectively measure these movements in living patients for the first time and assess how postoperative scarring affects these ranges. Additionally, the study will explore whether repairing the annulus during surgery provides any benefits in recovery outcomes. The findings could guide postoperative activity recommendations for patients.

Why it matters

Who can join: the full rules

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)

Where it's running

• Hospital General Universitario de Valencia
  Valencia, Valencia, Spain Recruiting

Study contacts

• Study coordinator: Vicente Vanaclocha, MDPhD
• Email: vivava@uv.es; vvanaclo@hotmail.com
• Phone: + 34 963 13 18 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.