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.
This study will be a prospective, open-label, multi-center study that will collect additional safety and efficacy data for the minimally invasive PerQdisc Nucleus Replacement Device (NRD). Patients will have degenerative disc disease (DDD) in one or more lumbar discs. The NRD is used for surgical replacement of a single nucleus pulposus between spinal lumbar discs L1-S1 using any standard anterior, standard lateral, or minimally invasive posterolateral surgical approach. Currently the surgical gold standard involves spinal fusion of the affected vertebral bodies, reducing range of motion and increasing stress on other vertebral bodies. The goal of nucleus replacement is to reduce chronic low back pain by maintaining disc height while preserving range of motion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Lumbar spine disc nucleus replacement system. All patients meeting all inclusion criteria and no exclusion criteria will be considered for nucleus replacement surgery following a review by the Medical Advisory Board.
CIGE: Centro de Imunologia y Genetica
Medellín, Antioquia, Colombia
ACTIVE_NOT_RECRUITINGFundacion Hospitalaria San Vicente de Paul
Medellín, Antioquia, Colombia
ACTIVE_NOT_RECRUITINGPerfromance: ODI
Change in in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool
Time frame: 6 months
Perfromance: ODI
Change in in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool
Time frame: 12 months
Performance: VAS
Change in back pain as measured by the 100 - millimeter Visual Analog Scale (VAS)
Time frame: 6 months
Performance: VAS
Change in back pain as measured by the 100 - millimeter Visual Analog Scale (VAS)
Time frame: 12 months
Safety: Expulsion & Device Failure
Incidence of device expulsion and device failure following surgery based on follow up X-rays and MRI's
Time frame: 6 months
Safety: Expulsion & Device Failure
Incidence of device expulsion and device failure following surgery based on follow up X-rays and MRI's
Time frame: 12 months
Safety: Revision Surgery
Incidence of revision surgery
Time frame: 6 months, 12 months, and 5 years
Safety: Expulsion & Device Failure
Incidence of device expulsion and device failure following surgery based on follow up X-rays and MRI's
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Cediul S.A.
Barranquilla, Atlántico, Colombia
ACTIVE_NOT_RECRUITINGFundación Campbell
Barranquilla, Atlántico, Colombia
WITHDRAWNSabbag Radiólogos S.A.
Barranquilla, Atlántico, Colombia
WITHDRAWNSociedad de Cirugia de Bogota- Hospital de San Jose
Bogotá, D.C., Colombia
ACTIVE_NOT_RECRUITINGClínica Imbanaco de Cali S.A.
Cali, Valle del Cauca Department, Colombia
ACTIVE_NOT_RECRUITINGPacífica Salud Hospital Punta Pacífica
Panama City, Provincia de Panamá, Panama
RECRUITINGSanatario Americano
Asunción, Paraguay
RECRUITINGRepublican Specialized Scientific Practical Medical Center of Endocrinology named after Academician Y.Kh. Turakulova
Tashkent, Uzbekistan
RECRUITINGTime frame: 5 years
Performance: Disc Height
Preservation of intervertebral disc height (in mm) as measured on MRI post-surgery compared to baseline
Time frame: 6 months, 12 months, and 5 years
Performance: RoM
Preservation of range of movement (expressed in degrees) at the index and adjacent levels at baseline compared to follow-up using flexion/extension radiographs
Time frame: 6 months, 12 months, 5 years
Safety: Neurological Status
Maintenance of baseline neurologic status through physical assessment evaluating nerve compression at baseline and post-surgical follow-up using pain, motor strength, and sensation feedback from the patient on a 0 (no compression) to 5 (major compression) scale
Time frame: 6 months, 12 months, and 5 years
Performance: Analgesic Score
Change in level of pain medication used comparing baseline to follow up visits based on a medication scale ranging from 0 (no meds) - 4 (high dose opioids)
Time frame: 6 months, 12 months, and 5 years
Safety: SAE
Incidence of serious adverse events that are related to the surgical procedure or Incidence of Serious Adverse Events related to the surgical procedure or device
Time frame: 6 months, 12 months, and 5 years