Actively Recruiting
"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
Led by Spinal Stabilization Technologies · Updated on 2026-03-03
72
Participants Needed
10
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is skeletally mature aged 22-70.
- Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1 with pain limited to a single level.
- Patient has adequate disc height (6 mm) at the level to be treated.
- Patient has had at least 6 months of conservative treatment for back pain.
- Patient has a preoperative Oswestry Disability questionnaire score of 40 or higher out of 100.
- Patient has a low back pain Visual Analog Scale (VAS) score of 40 mm or higher.
- Patient has signed the approved Informed Consent Form.
- All surgeries must be approved by the Medical Advisory Board (MAB).
You will not qualify if you...
- Patient has less than 6 mm of disc height.
- Patient has had prior lumbar spine surgery (except nucleoplasty at non-index level).
- Patient has had spinal fusion in lumbar or thoracic spine; cervical fusion allowed if no lower extremity neurologic deficits.
- Patient has spondyloarthropathy or spondylolisthesis greater than 2 mm.
- Patient has moderate or severe congenital spinal stenosis or epidural lipomatosis.
- Patient has significant facet disease with pain improvement of 80% or more after medial branch blocks.
- Patient has any active malignancy.
- Patient has been on immunosuppressive therapy (except steroids for inflammation).
- Patient has active or systemic infection.
- Patient has hepatitis, rheumatoid arthritis, lupus erythematosus, AIDS, ARC, or HIV.
- Patient has diabetes mellitus requiring daily insulin.
- Patient has osteopenia of the spine (T-score -1.0 or lower).
- Patient has morbid obesity (BMI over 40 or over 45 kg above ideal weight).
- Patient has known allergy to silicone or barium sulfate.
- Patient has significant disc herniation at the treated level posing expulsion risk.
- Patient has significant Schmorl's node with active inflammation at the treated level.
- Patient has less than 3 degrees motion on preoperative lateral flexion/extension radiographs.
- Patient belongs to vulnerable populations or cannot provide informed consent or comply with follow-up.
- Intraoperative exclusions include protrusion of imaging balloon beyond vertebra margin, violated endplate, too narrow disc space, poor visualization of Kambin's triangle, or sustained nerve root irritation during annular dilation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
CIGE: Centro de Imunologia y Genetica
Medellín, Antioquia, Colombia
Active, Not Recruiting
2
Fundacion Hospitalaria San Vicente de Paul
Medellín, Antioquia, Colombia
Active, Not Recruiting
3
Cediul S.A.
Barranquilla, Atlántico, Colombia
Active, Not Recruiting
4
Fundación Campbell
Barranquilla, Atlántico, Colombia
Withdrawn
5
Sabbag Radiólogos S.A.
Barranquilla, Atlántico, Colombia
Withdrawn
6
Sociedad de Cirugia de Bogota- Hospital de San Jose
Bogotá, D.C., Colombia
Active, Not Recruiting
7
Clínica Imbanaco de Cali S.A.
Cali, Valle del Cauca Department, Colombia
Active, Not Recruiting
8
Pacífica Salud Hospital Punta Pacífica
Panama City, Provincia de Panamá, Panama
Actively Recruiting
9
Sanatario Americano
Asunción, Paraguay, 1101
Actively Recruiting
10
Republican Specialized Scientific Practical Medical Center of Endocrinology named after Academician Y.Kh. Turakulova
Tashkent, Uzbekistan
Actively Recruiting
Research Team
A
Andy Murillo
CONTACT
M
Molly Bond
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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