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X-ray Visualized Interbody Spacer Indicating Biomechanical Load (X-VISIBL) Fusion Device

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AR078137-01A1
Agency Tracking Number: R41AR078137
Amount: $252,127.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAMS
Solicitation Number: PA19-270
Solicitation Year: 2019
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-01-18
Award End Date (Contract End Date): 2021-12-31
Small Business Information
Malden, MA 02148-5089
United States
DUNS: 002003243
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (978) 232-3990
Business Contact
Phone: (978) 232-3990
Research Institution
CLEMSON, SC 29634-0001
United States

 Nonprofit College or University

AbstractSpine 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.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.

* Information listed above is at the time of submission. *

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