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New treatment option for Lumbar Disc Disease
Official title Postoperative Scar in the Control Excess of Mobility Induced by Annulus Removal on Inserting a Lumbar Disc Prosthesis
ClinicalTrials.gov ID: NCT04641039
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join if
- 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...
- Pathology compatible with chronic low back pain accompanied or not by radiculopathy originating in one or a maximum of two degenerated intervertebral...
- 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...
- 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.
You likely can't join if
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Valencia, Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Valencia, Valencia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.