RecruitingNot ApplicableNCT04641039

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

Effect of the Postoperative Prevertebral Scar on Controlling Excess After Removing the Anterior Lumbar Disc Annulus Fibrosus to Implant a Lumbar Disc Prosthesis. Biomechanical and Clinical Study


Sponsor

University of Valencia

Enrollment

24 participants

Start Date

Nov 1, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether using a special scar-forming technique around a lumbar disc prosthesis (an artificial disc implanted in the lower back) can help prevent excessive movement and improve long-term outcomes after the implant. Lumbar disc replacement surgery is performed to treat chronic low back pain caused by degenerative disc disease — a condition where the cushioning discs between the spinal vertebrae break down. One challenge with disc prostheses is that too much movement at the implant site can cause complications. Controlled scar formation may act as a natural stabilizer. Patients aged 18 to 50 with chronic low back pain due to one or two degenerated discs, who have failed conservative treatment and have no contraindications, will undergo disc replacement surgery and be followed over time to assess outcomes including pain relief, mobility, and implant stability. You may be eligible if: - You are between 18 and 50 years of age - You have chronic low back pain caused by degeneration of one or two lumbar discs - Your pain worsens with bending forward and with loading - MRI confirms lumbar disc degeneration at one or two levels - You have tried and failed at least 6 weeks of conservative treatment - You have not had prior lumbar spine surgery You may NOT be eligible if: - You have osteoporosis, severe obesity (BMI above 35), or spinal deformity - You have a prior lumbar fracture, spinal metastasis, or metabolic bone disease - You have rheumatoid arthritis, lupus, or another autoimmune disease affecting the skeleton - You have an active infection or are HIV or hepatitis C positive - You have a psychiatric illness, uncontrolled seizures, or substance abuse - You have had prior lumbar surgery (at any level) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREAnterior lumbar disc annulus removal versus replacement

Owestry scale, SF12, Facet joint arthritis measured with Pathria scale, discal degeneration measured with Modic and Phirrmann scales


Locations(1)

Hospital General Universitario de Valencia

Valencia, Valencia, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04641039


Related Trials