Spine Clinical Registry
This research registry is focused on gathering data on patients who have undergone surgery for degenerative disc disease and back pain with the use of a particular cage product.
About
Protocol Description
A research registry is a collection of information about patients with a specific diagnosis or condition undergoing a particular treatment. This registry aims to collect clinical and imaging results of patients undergoing interbody fusion procedures with CONDUIT™ INTERBODY PLATFORM/ EIT CELLULAR TITANIUM® (collectively "Conduit/EIT implants"), sometimes referred to as "the cage." Conduit/EIT implants are 3D-printed titanium intervertebral body fusion devices.
The reason for this data collection is to learn about using this implant in the real-world setting. The data will look at the overall safety and clinical effectiveness of the cage at treating patients' pain over time.
Eligibility Criteria
Inclusion Criteria
- Subjects who have planned spinal fusion surgery with Conduit/EIT cages for specific indications
- Skeletally mature subjects at least 18 years of age
- Subjects had at least six (6) months of non-operative treatment prior to treatment with a lumbar intervertebral cage
- Willing to provide voluntary written informed consent prior to participation in the registry
Exclusion Criteria
- Subjects who had previous fusion surgery at needed spine levels
- Subjects who have demonstrated allergy or foreign body sensitivity to the implant material
- Pregnant subjects
- Diagnosed with severe osteoporosis or osteopenia which may prevent adequate fixation and thus preclude the use of these or any other orthopedic implant
- Diagnosed with severe instabilities, vertebral fractures, spinal tumors
- Subjects who have a systemic or metabolic disease which, in the PI’s opinion, would compromise their health, safety or ability to participate or follow-up in this registry
Primary Investigator
Gregory Howes, D.O., has clinical expertise in brain tumors, complex spine, cranial, functional neurosurgery, general neurosurgery, neuro-oncology including radiosurgery, deep brain stimulation, pain neuromodulation and minimally invasive spine. He has certifications in Principles and Practice of Gamma Knife Radiosurgery from the University of Pittsburgh as well as several notable publications, including "CyberKnife Stereotactic Radiosurgical Rhizotomy for Trigeminal Neuralgia: Anatomic and Morphological Considerations, Ganlioglioma Occurring with Glioblastoma Maltiforme: Separate Lesions or the Same Lesion?" and "Limited Microdiscectomy for Lumbar Disc Herniation: A Retrospective Long-Term Outcome Analysis." Dr. Howes primarily works with industry-sponsored clinical trials bringing new medical devices to his patients. His research interests include spinal surgery and pain management.
Contact Information
Nanci Dodson
Clinical Research Coordinator
