Segmental contribution toward total lumbar range of motion in disc replacement and fusions: a comparison of operative and adjacent levels.
Joshua D Auerbach, Kristofer J Jones, Andrew H Milby...
https://pubmed.ncbi.nlm.nih.gov/19927100Actively Recruiting
Phase Not Applicable
Age: 18Years - 50Years
All Genders
ID04641039
Effect of Postoperative Prevertebral Scar on Controlling Excess Movement After Anterior Lumbar Disc Annulus Fibrosus Removal During Lumbar Disc Prosthesis Implantation
Led by University of Valencia · Updated on 2026-04-22
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how removing the anterior portion of the annulus fibrosus during the implantation of a complete lumbar disc prosthesis affects spinal movement. This part of the annulus normally limits extension and axial rotation, so its removal may increase these movements. The study also evaluates whether the postoperative prevertebral scar reduces these abnormal movements and if repairing the anterior annulus during surgery improves patient outcomes. The trial involves two groups: one where the anterior annulus fibrosus is removed during disc prosthesis insertion, and another where the annulus is opened as flaps and replaced after prosthesis insertion. Participants will be randomly assigned to one of these groups. The study uses assessments like the Oswestry scale, SF12, and imaging to evaluate facet joint arthritis and disc degeneration. Participants will be monitored over time, with the primary outcome being the range of spinal segment movement at the L4-L5 level one year after surgery. Researchers will also assess pain and function scales, imaging results, and the presence of the prevertebral scar. This information aims to guide recommendations on when patients can safely resume normal activities and work after surgery.
CONDITIONS
Brief Title
Postoperative Scar in the Control Excess of Mobility Induced by Annulus Removal on Inserting a Lumbar Disc Prosthesis
Who Can Participate
Age: 18Years - 50Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 50 years
- Chronic low back pain compatible with discogenic pain from one or two degenerated lumbar discs
- Radiological confirmation by lumbar MRI of discopathy at one or two lumbar levels
- No signs of degeneration or osteoarthritis of the lumbar joint facets
- No vertebral instability or listhesis at the treated levels
- No response to 6 weeks of conservative treatment or presence of progressive symptoms
- No prior surgery of microdiscectomy, laminectomy, or lumbar arthrodesis at the same levels
- Ability to comply with monitoring and postoperative care
- Informed consent given
You will not qualify if you...
- Signs of arthropathy of lumbar joint facets, osteoporosis, or previous lumbar spine interventions
- Lumbar spine deformity or instability
- Lumbar canal stenosis
- Previous lumbar spinal fracture
- Mobile spondylolisthesis greater than 2 mm translation or more than 11° angular difference
- Severe osteoporosis
- Spinal metastasis or metabolic bone disease affecting surgery
- Autoimmune diseases like rheumatoid arthritis or lupus affecting musculoskeletal system
- Conditions making anterior lumbar spine surgery unfeasible
- Known allergy to stainless steel, titanium, or alloys
- Fixed or permanent neurological deficit
- Active systemic infection or preventive treatment for infection
- Abusive drug or alcohol use
- Uncontrolled seizure disorder
- Psychiatric illness interfering with participation
- Participation in another research study within 3 months prior
- History of malignancy within 5 years except treated non-melanoma skin cancer
- Obesity with Body Mass Index over 35
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery plus immediate recovery period
Participants undergo lumbar disc prosthesis implantation involving removal or replacement of the anterior portion of the annulus fibrosus.
1 surgery visit and hospital stay
Post-operative Follow-up
Duration - Up to 1 year
Participants are monitored to assess spinal segment movement and recovery after surgery, including evaluation of prevertebral scar effects and functional outcomes.
Periodic follow-up visits over the year
Trial Site Locations
Total: 1 location
1
Hospital General Universitario de Valencia
Valencia, Valencia, Spain, 46014
Actively Recruiting
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Research Team
V
Vicente Vanaclocha, MDPhD
T
Teresa Moratal, Secretary
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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Published Research Related To This Trial
Comparison of lumbar pedicular dynamic stabilisation systems versus fusion for the treatment of lumbar degenerative disc disease: A meta-analysis.
Y-J Huang, S-J Zhao, Q Zhang...
https://pubmed.ncbi.nlm.nih.gov/29322911Lumbar total disc replacement part I: rationale, biomechanics, and implant types.
Peter Frelinghuysen, Russel C Huang, Federico P Girardi...
https://pubmed.ncbi.nlm.nih.gov/15950689