Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumbar Disc Nucleus Replacement | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PerQdisc Nucleus Replacement System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Perfromance: ODI | Change in in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool | 6 months |
| Perfromance: ODI | Change in in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool | 12 months |
| Performance: VAS | Change in back pain as measured by the 100 - millimeter Visual Analog Scale (VAS) | 6 months |
| Performance: VAS | Change in back pain as measured by the 100 - millimeter Visual Analog Scale (VAS) | 12 months |
| Safety: Expulsion & Device Failure | Incidence of device expulsion and device failure following surgery based on follow up X-rays and MRI's | 6 months |
| Safety: Expulsion & Device Failure | Incidence of device expulsion and device failure following surgery based on follow up X-rays and MRI's | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Revision Surgery | Incidence of revision surgery | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Intraoperative Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maren Lange | Contact | 8004841588 | mlange@sstspine.com | |
| Molly Bond | Contact | 1 (715) 577-7527 | mbond@sstspine.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael Hess, MD | London Spine Clinic/ATOS-Klinik | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIGE: Centro de Imunologia y Genetica | Active, not recruiting | Medellín | Antioquia | Colombia | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label study. Patients will receive one implant if they meet all inclusion/exclusion criteria after a review by the Medical Advisory Board (MAB).
Not provided
Not provided
Not provided
Not provided
| 5 years |
| Performance: Disc Height | Preservation of intervertebral disc height (in mm) as measured on MRI post-surgery compared to baseline | 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 | 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 | 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) | 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 | 6 months, 12 months, and 5 years |
| Fundacion Hospitalaria San Vicente de Paul |
| Active, not recruiting |
| Medellín |
| Antioquia |
| Colombia |
| Cediul S.A. | Active, not recruiting | Barranquilla | Atlántico | Colombia |
| Fundación Campbell | Withdrawn | Barranquilla | Atlántico | Colombia |
| Sabbag Radiólogos S.A. | Withdrawn | Barranquilla | Atlántico | Colombia |
| Sociedad de Cirugia de Bogota- Hospital de San Jose | Active, not recruiting | Bogotá | D.C. | Colombia |
| Clínica Imbanaco de Cali S.A. | Active, not recruiting | Cali | Valle del Cauca Department | Colombia |
| Pacífica Salud Hospital Punta Pacífica | Recruiting | Panama City | Provincia de Panamá | Panama |
|
| Sanatario Americano | Recruiting | Asunción | 1101 | Paraguay |
|
| Republican Specialized Scientific Practical Medical Center of Endocrinology named after Academician Y.Kh. Turakulova | Recruiting | Tashkent | Uzbekistan |
|
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D007405 | Intervertebral Disc Displacement |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided