Minimally invasive artificial disc replacement for chronic low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Life Science Center for Innovation Hospital Clinica Biblica
  San José, Costa Rica 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
• CIGE: Centro de Imunologia y Genetica
  Medellín, Antioquia, Colombia Active not recruiting
• Fundacion Hospitalaria San Vicente de Paul
  Medellín, Antioquia, Colombia Active not recruiting

Study contacts

• Study coordinator: Maren Lange
• Email: mlange@sstspine.com
• Phone: 8004841588

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.