Actively Recruiting
Postoperative Scar in the Control Excess of Mobility Induced by Annulus Removal on Inserting a Lumbar Disc Prosthesis
Led by University of Valencia · Updated on 2026-04-22
24
Participants Needed
1
Research Sites
477 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Postoperative Scar in the Control Excess of Mobility Induced by Annulus Removal on Inserting a Lumbar Disc Prosthesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 50 years
- Chronic low back pain compatible with discogenic pain, worsening in flexion and loading, with or without radiculopathy from one or two degenerated lumbar discs
- Radiological confirmation of lumbar discopathy at one or two lumbar levels by MRI
- No signs of degeneration or osteoarthritis in lumbar joint facets
- No vertebral instability or listhesis in the levels to be treated based on simple radiology
- No response after 6 weeks of conservative non-surgical treatment or presence of progressive symptoms
- No prior treatment like microdiscectomy, laminectomy, or lumbar arthrodesis at the involved levels
- Ability to comply with the monitoring and postoperative care programs
- Informed consent granted
You will not qualify if you...
- Signs of arthropathy of lumbar joint facets, osteoporosis, or previous lumbar spine surgeries
- Deformity or instability of the lumbar spine
- Lumbar canal stenosis
- Previous lumbar spinal fracture
- Mobile spondylolisthesis greater than 2 mm translation or more than 11° angular difference at adjacent levels
- Severe osteoporosis
- Spinal metastasis or metabolic bone diseases affecting surgery
- Autoimmune diseases affecting the musculoskeletal system like rheumatoid arthritis or lupus
- Conditions or anatomical issues preventing anterior lumbar spine surgery
- Known allergy to stainless steel, titanium, or their alloys
- Fixed or permanent neurological deficits
- Active systemic infections, HIV, hepatitis C, or ongoing preventive infection treatments
- Abusive drug or alcohol use
- Uncontrolled seizure disorder
- Psychiatric illness interfering with study participation
- Participation in another research study within 3 months prior to surgery
- History or current malignancy except treated non-melanoma skin cancer with no symptoms for at least 5 years
- Obesity with Body Mass Index over 35
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital General Universitario de Valencia
Valencia, Valencia, Spain, 46014
Actively Recruiting
Research Team
V
Vicente Vanaclocha, MDPhD
CONTACT
T
Teresa Moratal, Secretary
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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