An interventional study of Anterior lumbar disc annulus removal versus replacement in Lumbar Disc Disease, sponsored by University of Valencia. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by University of Valencia · Not applicable, Interventional, and Treatment
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.
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
63 studies on the registry are indexed under Intervertebral disc disease; 18 are open to participants now.
This study's planned enrollment of 24 is below the median of 78 across 37 interventional studies indexed under Intervertebral disc disease.
Browse Intervertebral disc disease studies →University of Valencia is the lead sponsor of 357 studies on the registry; 75 are open to participants now.
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Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
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Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In these patients the anterior portion of the annulus fibrosus will be removed when inserting a complete lumbar disc prosthesis
Procedure: Anterior lumbar disc annulus removal versus 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
Procedure: 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
Range of spinal segment movement after lumbar disc prosthesis insertion in L4-L5 lumbar disc
The investigators will analyze preoperatively and postoperatively at 3, 6 and 12 months the range of movement of the L4-L5 lumbar disc after insertion of a complete lumbar disc prosthesis
Time frame: One year
Plan to share: No
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