SBIR-STTR Award

Optimization of a Novel Thread Geometry for Various Orthopaedic Surgery Applications
Award last edited on: 2/15/22

Sponsored Program
SBIR
Awarding Agency
NIH : NIAMS
Total Award Amount
$225,000
Award Phase
1
Solicitation Topic Code
NIAMS
Principal Investigator
Andrew R Fauth

Company Information

OsteoCentric Technologies Inc (AKA: SMV Scientific LLC~Summit Med Ventures)

111 Sandra Muraida Way Unit 18A
Austin, TX 78703
   (800) 969-0639
   info@osteocentric.com
   www.osteocentric.com
Location: Single
Congr. District: 25
County: Travis

Phase I

Contract Number: 1R43AR073096-01A1
Start Date: 9/18/18    Completed: 7/31/19
Phase I year
2018
Phase I Amount
$225,000
Among the multiplicity of thread shapes, the buttress thread design remains the historic paradigm for the shape of current orthopedic screws. The popularity of buttress threads in current orthopedic screw designs is reflected by the advantage of handling high axial thrust in one direction, which leads to increased shear strength and improved unidirectional pullout resistance compared to other conventional thread shapes. However, orthopedic screws are typically not challenged by axial loading forces from physiological motion in- vivo. Thus, standard buttress screws remain at a significant risk of failure when exposed to multidirectional loading forces. To address the physiological multiaxial loading environment, newer generation locking plates have been able to reduce the risk of implant failure, particularly in osteoporotic bone. Locked plating relies on the benefit of a fixed-angle construct that does not rely on friction and compression between implant and bone. However, locking head screws have been shown to have their own set of shortcomings, including the stiffness of plate-screw constructs, asymmetric callous formation and increased cost, hence the need for continued research towards more effective and cost-conscientious solutions. SMV Scientific has designed a new bone- screw-fastener, entitled SMV Bone Interlocking Thread Geometry (BITG) that distributes forces from the implant onto the bone and subsequently resists loads in all directions. The new fastener consists of a ?female thread? bone cutting technology designed to maximize bone volume, preserve bone architecture, and create a circumferential interlocking interface between the implant and bone. BITG resists multidirectional forces and bending moments to limit toggling and minimize radial forces; therefore, improving resistance to failure and decreasing risk of creating stress risers and iatrogenic fractures; BITG allows for higher finishing torques compared to buttress screws and resists screw stripping; and the BITG cutting mechanism curls the bone chips away from the cutting edges to create a debris free, solid bone-implant interface in order to present iatrogenic bone destruction during screw insertion. However, this novel thread geometry has not been optimized for cortical and trabecular bone orthopaedic applications in normal and osteoporotic bone stock, while subjected to different loading conditions. We hypothesize that the optimized BITG screws will provide improved multidirectional load resistance, when compared to buttress screws, for cortical and trabecular screws under different loading conditions and bone types. Therefore, we propose to conduct a parametric finite element (FE) analysis based study to optimize the BITG screws for orthopaedic use. Specific Aim 1: Validate our existing bone thread interface FE model with a cadaveric study using clinically relevant loading conditions. Specific Aim 2: Use the validated FE model to conduct a parametric FE analysis to optimize thread geometry for cortical and trabecular screws.

Project Terms:
Activities of Daily Living; Address; Architecture; Area Under Curve; austin; base; bone; Bone Screws; Businesses; Cadaver; Clinical; clinically relevant; Complex; cortical bone; cost; cost effective; Data; design; Development; Distal; Elements; Environment; Exposure to; Face; Failure; Female; fibula; Finite Element Analysis; Fracture; Fracture Fixation; Friction; Generations; Geometry; Head; Healthcare Systems; Iatrogenesis; Image; Implant; improved; in vivo; innovation; Life; male; Mechanics; Modeling; Motion; novel; Orthopedic Surgery procedures; Orthopedics; Osteoporotic; osteoporotic bone; Patients; Performance; Phase; Physiological; Plant Roots; Positioning Attribute; Postoperative Complications; Price; Probability; Radial; Randomized Clinical Trials; Research; Resistance; Risk; sample fixation; Shapes; Shear Strength; shear stress; Solid; Stainless Steel; Stress; substantia spongiosa; Technology; Testing; tibia; Titanium; tool; Tooth structure; Torque; Torsion; Width; Work;

Phase II

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Start Date: 00/00/00    Completed: 00/00/00
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