Spine disorders, primarily caused by degenerative spine conditions, deformity, tumors, and trauma, affect approximately half of the population aged over 40. To address these disorders, over 457,000 spine fusions were performed in the US in 2011 (6% annual growth), including about 290,000 anterior cervical discectomy and fusions (ACDF). ACDF surgery removes 1-4 intervertebral discs and replaces them with interbody spacers filled with bone graft. This distracts and decompress the nerve roots while fusing the adjacent vertebrae. Postoperatively, it is critical to recognize when the vertebrae have fused, an outcome that determines safe return to activity; conversely, delayed fusion may indicate need for additional interventions (e.g., prolonged collar usage, modified physical therapy, electrical stimulation, and injections such as rhPTH). Improper management can lead to poor outcomes, worse pain, surgical revision and neurological deficits. Unfortunately, patients heal at rates that vary greatly, and some patients will not heal properly with 7% needing costly revision surgery ($123,000 hospital charges).We propose to develop an X-ray Visible Interbody Spacer Indicating Biomechanical Load (X-VISIBL) fusion device to assist clinicians in tracking and detecting bony fusion. If successful, this project will validate a simple indicator that reports load on the device to assess fusion of the adjacent bones. Measurements are made using flexion/extension radiography which is already routinely used in patient follow-up but is currently insufficiently sensitive to detect delayed fusion and non-union. Monitoring implant load will provide the patient and medical team critical information to select early targeted interventions including prolonged brace or collar usage, modified physical therapy and return-to-work protocols, ultrasound or electrical stimulation, medications or injections such as rhPTH, and inform long term care to avoid device failure and associated pain, disability and reoperations.This Phase I Small Business Technology Transfer project aims to assess technical feasibility for a load indicating cervical interbody spacer. The approach is innovative in providing a sensor to clearly measure load during fusion with X-ray readout that is already part of the standard of care. To show feasibility, we must develop prototypes with mechanical properties that allow/encourage fusion (especially stiffness and yield) and the precision to detect physiological load changes during fusion. This will be accomplished with computer simulations, mechanical prototype fabrication and testing, and radiography in cadaveric models.The research is relevant to public health because, it provides an objective non-invasive means to assess biomechanical fusion and assist physicians prescribing rehabilitation protocols and adjunctive therapies. Public Health Relevance Statement Project Narrative This research project develops a first-in-kind load-indicating vertebral interbody spacer that enables physicians to track fusion status using routine flexion/extension radiography. The research is relevant to public health because it provides objective metrics to assess fusion in individual patients to inform decisions on rehabilitation protocols and adjunctive therapies.
Project Terms: Affect ; Anatomy ; Anatomic ; Anatomic Sites ; Anatomic structures ; Anatomical Sciences ; Biomechanics ; biomechanical ; bone ; Bone Transplantation ; Bone Grafting ; bone transplant ; Cadaver ; Calibration ; Neck Pain ; Cervical Pain ; Cervicalgia ; Cervicalgias ; Cervicodynia ; Cervicodynias ; Neck Ache ; Neckache ; Computer Simulation ; Computer based Simulation ; computational simulation ; computerized simulation ; Diagnosis ; Disease ; Disorder ; Pharmaceutical Preparations ; Drugs ; Medication ; Pharmaceutic Preparations ; drug/agent ; Electric Stimulation ; Electrical Stimulation ; electrostimulation ; Elements ; Goals ; Gold ; Growth ; Generalized Growth ; Tissue Growth ; ontogeny ; Human ; Modern Man ; In Vitro ; instrumentation ; Interobserver Variability ; Inter-Observer Variability ; Inter-Observer Variation ; Interobserver Variations ; Intervertebral disc structure ; Intervertebral Disk ; Interview ; Lead ; Pb element ; heavy metal Pb ; heavy metal lead ; Long-Term Care ; extended care ; longterm care ; Methods ; Motion ; Muscle Contraction ; Muscle Cell Contraction ; Muscular Contraction ; Neck ; Nerve ; Pain ; Painful ; Patients ; Physicians ; Postoperative Period ; Post-Operative ; Postoperative ; Public Health ; Rehabilitation therapy ; Medical Rehabilitation ; Rehabilitation ; rehab therapy ; rehabilitative ; rehabilitative therapy ; Repeat Surgery ; Reoperation ; Research ; Spinal Diseases ; spine disorder ; Spinal Fusion ; Spondylosyndeses ; Vertebral column ; Spinal Column ; Spine ; backbone ; Testing ; Time ; X-Ray Computed Tomography ; CAT scan ; CT X Ray ; CT Xray ; CT imaging ; CT scan ; Computed Tomography ; Tomodensitometry ; X-Ray CAT Scan ; X-Ray Computerized Tomography ; Xray CAT scan ; Xray Computed Tomography ; Xray computerized tomography ; catscan ; computed axial tomography ; computer tomography ; computerized axial tomography ; computerized tomography ; Ultrasonography ; Echography ; Echotomography ; Medical Ultrasound ; Ultrasonic Imaging ; Ultrasonogram ; Ultrasound Diagnosis ; Ultrasound Medical Imaging ; Ultrasound Test ; diagnostic ultrasound ; sonogram ; sonography ; sound measurement ; ultrasound ; ultrasound imaging ; ultrasound scanning ; Voice ; Work ; Diagnostic radiologic examination ; Conventional X-Ray ; Diagnostic Radiology ; Diagnostic X-Ray ; Diagnostic X-Ray Radiology ; Radiography ; Roentgenography ; X-Ray Imaging ; X-Ray Medical Imaging ; Xray imaging ; Xray medical imaging ; conventional Xray ; diagnostic Xray ; diagnostic Xray radiology ; Roentgen Rays ; X-Radiation ; X-Ray Radiation ; X-ray ; Xray ; Measures ; Businesses ; Equipment Malfunction ; Device Failures ; Caring ; base ; sensor ; Procedures ; Cervical ; Anterior ; Clinical ; Phase ; Biological ; Physiological ; Physiologic ; Medical ; Series ; Hospital Costs ; Hospitalization cost ; Hospital Charges ; Physical activity ; disability ; Measurement ; Plant Roots ; root ; Technology Transfer ; Research Project Grants ; R-Series Research Projects ; R01 Mechanism ; R01 Program ; Research Grants ; Research Projects ; Anatomic Abnormality ; Anatomical Abnormality ; Deformity ; fluid ; liquid ; Liquid substance ; Shapes ; programs ; mechanical ; Mechanics ; Scanning ; Protocol ; Protocols documentation ; Neurologic Deficit ; Operative Procedures ; Surgical ; Surgical Interventions ; Surgical Procedure ; surgery ; Operative Surgical Procedures ; Vertebrae ; Vertebral ; spine bone structure ; Radiation Dose ; Radiation Dose Unit ; Performance ; simulation ; novel ; model-based simulation ; models and simulation ; Devices ; Reporting ; Radiculopathy ; Cervical Vertebrae ; Cervical spine ; Modeling ; response ; Intervention Strategies ; interventional strategy ; Intervention ; Second Look ; Surgical Revision ; Second Look Surgery ; Physiatric Procedure ; Physical Medicine Procedure ; Physical Therapeutics ; Physiotherapy ; Physical therapy ; Bone Growth ; Address ; Length ; Symptoms ; Small Business Technology Transfer Research ; STTR ; Monitor ; Characteristics ; Process ; sex ; follow-up ; Active Follow-up ; active followup ; follow up ; followed up ; followup ; Development ; developmental ; cost ; healing ; design ; designing ; bone quality ; Clinical effectiveness ; Outcome ; Population ; aged ; Consumption ; Trauma ; innovation ; innovate ; innovative ; Implant ; bone healing ; bone wound healing ; osseous wound healing ; prototype ; tumor ; standard of care ; 3D Print ; 3-D print ; 3-D printer ; 3D printer ; 3D printing ; three dimensional printing ; Innovation Corps ; I-Corps ; individual patient ; physical therapist ; physiotherapist ; mechanical properties ; Modulus ; implant design ; imaging study ; Injections ; in silico ; Impaired healing ; Healing abnormal ; Healing delayed ;
