Minimally invasive artificial disc replacement for chronic low back pain

"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

This study is testing a new device for replacing damaged discs in the lower back to see if it can help people with chronic back pain feel better without the downsides of traditional surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Spinal Stabilization Technologies (Industry-sponsored)
• Locations: 10 sites (Medellín, Antioquia and 9 other locations)
• Trial ID: NCT05508360 on ClinicalTrials.gov

What this trial studies

This prospective, open-label, multi-center study aims to gather safety and efficacy data for the PerQdisc Nucleus Replacement Device in patients with degenerative disc disease. The device is designed for surgical replacement of the nucleus pulposus in lumbar discs, utilizing various surgical approaches. By maintaining disc height and preserving range of motion, the study seeks to alleviate chronic low back pain, which is often exacerbated by traditional spinal fusion methods. A total of 72 patients will be enrolled to evaluate the outcomes of this innovative treatment.

Who should consider this trial

Good fit: Ideal candidates are skeletally mature individuals aged 22-70 with degenerative disc disease at a single lumbar level who have not responded to conservative treatments.

Not a fit: Patients with insufficient disc height or prior lumbar spine surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce chronic low back pain while preserving spinal mobility for patients.

How similar studies have performed: Other studies have shown promise with similar nucleus replacement approaches, indicating potential for success in this novel application.

Eligibility criteria

Inclusion 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)

Exclusion Criteria:

* 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 controlled).
* 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, disabled, prisoner, chronic alcohol/ substance abuser)

Intraoperative Exclusion Criteria:

* 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.

Where this trial is running

Medellín, Antioquia and 9 other locations

• CIGE: Centro de Imunologia y Genetica — Medellín, Antioquia, Colombia (Active_not_recruiting)
• Fundacion Hospitalaria San Vicente de Paul — Medellín, Antioquia, Colombia (Active_not_recruiting)
• Cediul S.A. — Barranquilla, Atlántico, Colombia (Active_not_recruiting)
• Fundación Campbell — Barranquilla, Atlántico, Colombia (Withdrawn)
• Sabbag Radiólogos S.A. — Barranquilla, Atlántico, Colombia (Withdrawn)
• Sociedad de Cirugia de Bogota- Hospital de San Jose — Bogotá, D.c., Colombia (Active_not_recruiting)
• Clínica Imbanaco de Cali S.A. — Cali, Valle del Cauca Department, Colombia (Active_not_recruiting)
• Pacífica Salud Hospital Punta Pacífica — Panama City, Provincia de Panamá, Panama (Recruiting)
• Sanatario Americano — Asunción, Paraguay (Recruiting)
• Republican Specialized Scientific Practical Medical Center of Endocrinology named after Academician Y.Kh. Turakulova — Tashkent, Uzbekistan (Recruiting)

Study contacts

• Study coordinator: Andy Murillo

Conditions Degenerative Disc Disease; Chronic Low-back Pain; DDD; Chronic Low Back Pain; cLBP; Disc Herniation; Nucleus Replacement; Low Back Pain