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New treatment option for Degenerative Disc Disease
Official title "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
ClinicalTrials.gov ID: NCT05508360
What this study is testing
- What it's testing
- This study will be a prospective, open-label, multi-center study including 72 patients that will collect additional safety and efficacy data for the Spinal Stabilization Technologies PerQdisc Nucleus Replacement System.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Patient is skeletally mature aged 22-70.
- Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1 but the discogenic pain must be limited to a single level.
- Patient has adequate disc height (6mm) at the level to be treated
- Patient has exhausted a minimum of 6 months of conservative treatment for their back (e.g. physical therapy, medications, injections, life style...
- Patient has a preoperative Oswestry Disability questionnaire score ≥ 40 out of 100 points (40/100)
You likely can't join if
- Patient has less than 6 mm of disc height.
- Patient has had prior lumbar spine surgery (nucleoplasty at non-index level is considered acceptable).
- Patient has had spinal fusion in the lumbar or thoracic intervertebral spaces. Cervical fusion is allowed as long as there are no neurologic deficits...
- Patient has spondyloarthropathy or other spondylolisthesis greater than 2 mm.
- Patient has congenital moderate or severe spinal stenosis or epidural lipomatosis.
- Patient has significant facet disease. Significant is defined as pain improvement of 80% or more following image-guided medial branch blocks of the...
See the full eligibility criteria
- Patient is skeletally mature aged 22-70.
- Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1 but the discogenic pain must be limited to a single level.
- Patient has adequate disc height (6mm) at the level to be treated
- Patient has exhausted a minimum of 6 months of conservative treatment for their back (e.g. physical therapy, medications, injections, life style changes, etc).
- Patient has a preoperative Oswestry Disability questionnaire score ≥ 40 out of 100 points (40/100)
- Patient has a low back pain Visual Analog Scale (VAS) ≥ 40 mm (4 cm)
- Patient has signed the approved Informed Consent Form.
- All surgeries must be approved by the Medical Advisory Board (MAB)
- Patient has less than 6 mm of disc height.
- Patient has had prior lumbar spine surgery (nucleoplasty at non-index level is considered acceptable).
- Patient has had spinal fusion in the lumbar or thoracic intervertebral spaces. Cervical fusion is allowed as long as there are no neurologic deficits in the lower extremities.
- Patient has spondyloarthropathy or other spondylolisthesis greater than 2 mm.
- Patient has congenital moderate or severe spinal stenosis or epidural lipomatosis.
- Patient has significant facet disease. Significant is defined as pain improvement of 80% or more following image-guided medial branch blocks of the target level according to SIS guidelines (diagnostic, contrast...
- Patient has any known active malignancy.
- Patient has previously undergone or currently on immunosuppressive therapy. Steroids used to treat inflammation are allowed.
- Patient has active or local systemic infection.
- Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupus erythematosus, or other autoimmune disease including AIDS, ARC and HIV.
- Patient has diabetes mellitus (Type 1 or 2) requiring daily insulin management.
- Patient has osteopenia of the spine (T-score of -1.0 or lower). A DEXA scan should be performed to rule out patients considered at risk for osteopenia.
- Patient has morbid obesity defined as a body mass index (BMI) more than 40 or a weight of more than 45 kg (100 lbs.) over ideal body weight.
- Patient has a known allergy to silicone or barium sulfate.
- Patient has a significant disc herniation at the level to be treated. Significant is defined as a large, extruded herniation that creates a risk for expulsion.
- Patient has a significant Schmorl's node in the level to be treated. Significant is defined as a large, rectangular or irregular shaped node that has an associated active inflammatory process (Modic I changes).
- Patient has motion of less than 3 degrees on pre-operative lateral flexion/extension radiographs.
- Patient belongs to a vulnerable population or has a condition such that his/her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g. developmentally...
- Protrusion of the 20A Imaging Balloon up to or beyond the outer margin of the vertebra during the imaging steps.
- Patient has a violated endplate as determined by imaging balloons during fluoroscopy.
- Patient has a disc space that is too narrow for implantation. MIPL Specific
- Poor radiological visualization of Kambin's triangle.
- Sustained irritation of the exiting nerve root during any aspect of the annular dilation technique (leg movement or if performing with electrical monitoring) in spite or repositioning instruments.
The study team makes the final eligibility decision.
Where it's taking place
- Medellín, Antioquia, Colombia
- Barranquilla, Atlántico, Colombia
- Bogotá, D.C., Colombia
- Cali, Valle del Cauca Department, Colombia
- Panama City, Provincia de Panamá, Panama
- Asunción, Paraguay
- Tashkent, Uzbekistan
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, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Medellín, Antioquia, Colombia; Barranquilla, Atlántico, Colombia; Bogotá, D.C., Colombia; Cali, Valle del Cauca Department, Colombia; Panama City, Provincia de Panamá, Panama; Asunción, Paraguay and 1 more location(s). 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.