SBIR-STTR Award

The distal radius is one of the most common sites of bone fracture and is the most common fracture site in the upper extremity, accounting for approximately 10% of all fractures in adults. Approximately 25% of patients (~80,000/year) require surgery to correctly repair this bone, and current practice requires the surgeon to disrupt the soft tissues surrounding the joint to expose the bone for placement of hardware to stabilize the fracture. Thus, improved joint stability is achieved by sacrificing the integrity of an extensive tendon, ligament and neuromuscular network that is needed for proper wrist function. EndoOrthopaedic's core technology is a universal system of telescopic, micro-adjustable bone implants (TABI) for intramedullary fixation that can be assembled by the surgeon entirely within a fracture to restore the shape of the articulating surfaces. Adaptation of our TABI device for intramedullary fracture fixation of the distal radius would provide orthopaedic surgeons with a valuable option in the treatment of distal radial fractures. The device is designed to be deployed during a minimally invasive surgery, thereby reducing the cost of each surgery and minimizing the risk associated with soft tissue damage during the procedure. Also, since the device is completely intramedullary, it will not interfere with the soft tissues after the fracture has healed, which will substantially reduce the need for revision surgeries. For these reasons, the TABI device will lead to an overall reduction in the costs associated with treatment of distal radial fractures. Despite the advantages of intramedullary fixation, there has been limited evidence demonstrating the ability of an intramedullary device to sufficiently resist interfragmentary strains in distal radial fractures during habitual loading. The device must also have sufficient strength to prevent re-fracture during periodic overloading. In order to meet these requirements, the TABI device has been designed using proprietary methods of stabilizing distal radius fractures to minimize the relative motion between fragments. Therefore, our hypothesis is that intramedullary fixation of the distal radial metaphysis using the TABI device will sufficiently stabilize the fracture for repair. We will test this hypothesis with the following aims: (1) evaluate the ability of the EndoOrthopaedics device (TABI) to resist periodic overloading, and (2) to verify the ability of the TABI device to sufficiently stabilize the fracture and maintain interfragmentary strains below the threshold for fracture healing under sustained habitual mechanical loading. These experiments will determine the feasibility of the TABI device for distal radial fractures, and in Phase 2, we will perform in situ testing of the device to predict its biological effect on fracture healing.

Public Health Relevance:
Relevance The distal radius is one of the most common sites of bone fracture and is the most common fracture site in the upper extremity. Approximately 25% of patients (~80,000/year) require surgery to correctly repair this bone, although current treatments for this type of fracture require substantial disruption the soft tissues surrounding the joint. EndoOrthopaedic's core fracture fixation technology (TABI) can be assembled by the surgeon entirely within the fracture during a minimally invasive procedure, which will limit patient discomfort and minimize soft tissue damage. The overall objective of this study is to determine the feasibility of using our TABI device to repair a distal radial fracture.

Thesaurus Terms:
21+ Years Old;Accounting;Active Follow-Up;Adoption;Adult;Anatomic;Anatomical Sciences;Anatomy;Animal Model;Animal Models And Related Studies;Articulation;Biological;Biomechanics;Blood Vessels;Bone;Bone Regeneration;Bone And Bones;Bone Callus;Bone Plates;Bones And Bone Tissue;Bony Callus;Cadaver;Caliber;Callus;Clinical;Compression Fracture;Data;Devices;Diameter;Distal;Elements;Equipment Malfunction;Flr;Failure (Biologic Function);Failures, Device;Fixation;Forearm;Fracture;Fracture Fixation;Fracture Fixation, Intramedullary;Fracture Healing;Hand Functions;Healed;Human;Human, Adult;Human, General;Implant;In Situ;Incidence;Intramedullary Fracture Fixation;Joints;Lead;Length;Ligaments;Malfunction, Equipment;Man (Taxonomy);Man, Modern;Measures;Mechanics;Membrum Superius;Metaphysis;Methods;Minor;Modeling;Motion;Nerve;Nervous;Operation;Operative Procedures;Operative Surgical Procedures;Orthopedic;Orthopedic Surgical Profession;Orthopedics;Osteosynthesis, Fracture, Intramedullary;Patients;Pb Element;Performance;Phase;Position;Positioning Attribute;Post-Operative;Postoperative;Postoperative Period;Procedures;Property;Property, Loinc Axis 2;Radial;Radius Fractures;Recovery;Relative;Relative (Related Person);Risk;Rod;Rod Photoreceptors;Rods (Eye);Rods (Retina);Science Of Anatomy;Shapes;Site;Skeletal Fixation;Surface;Surgeon;Surgical;Surgical Interventions;Surgical Procedure;System;System, Loinc Axis 4;Technology;Tendon Structure;Tendons;Testing;Time;Torsion;Torsion (Malposition);Treatment Cost;Upper Extremity;Upper Limb;Using Hands;Visit;Wrist;Adult Human (21+);Anatomy;Base;Biomedical Implant;Bone;Bone Fracture;Bone Repair;Cantilever;Cost;Design;Designing;Experiment;Experimental Research;Experimental Study;Failure;Follow-Up;Healing;Heavy Metal Pb;Heavy Metal Lead;Implant Device;Implantable Device;Improved;Indwelling Device;Meetings;Minimally Invasive;Model;Model Organism;Neuromuscular;Novel;Prevent;Preventing;Repair;Repaired;Research Study;Rod Cell;Sample Fixation;Soft Tissue;Surgery;Vascular;Wrist Fracture

The distal radius is one of the most common sites of bone fracture and is the most common fracture site in the upper extremity, accounting for approximately 10% of all fractures in adults. Approximately 25% of patients (~80,000/year) require surgery to correctly repair this bone, and current practice requires the surgeon to disrupt the soft tissues surrounding the joint to expose the bone for placement of hardware to stabilize the fracture. Thus, improved joint stability is achieved by sacrificing the integrity of an extensie tendon, ligament and neuromuscular network that is needed for proper wrist function. EndoOrthopaedic's core technology is a universal system of trans-cortical, micro-adjustable bone implants (TABI) for intramedullary fixation that can be assembled by the surgeon entirely within a fracture to restore the shape of the articulating surfaces. Adaptation of our TABI device for intramedullary fracture fixation of the distal radius would provide orthopaedic surgeons with a valuable option in the treatment of distal radial fractures. The device is designed to be deployed during a minimally invasive surgery, thereby reducing the cost of each surgery and minimizing the risk associated with soft tissue damage during the procedure. Also, since the device is completely intramedullary, it will not interfere with the soft tissues after the fracture has heale, which will substantially reduce the need for revision surgeries. For these reasons, the TABI device will lead to an overall reduction in the costs associated with treatment of distal radial fractures. In Phase I of this project, we demonstrated that our device was sufficient to resist interfragmentary strains in distal radial fractures during habitual loading and could prevent re-fracture during periodic overloading. During Phase II, our overall objective is to evaluate the mechanical performance of specific TABI device features that are designed to enable an efficient implantation procedure. We will thus validate the number of surgical steps required to implant the TABI device with the following specific aims: (1) to measure the implantation force of the intramedullary pins to verify sufficient haptic feedback for intuitive deployment by the surgeon; (2) to validate the strength of intramedullary pin attachment to a central hub, and (3) to demonstrate the surgical efficiency and mechanical performance of the TABI device. At the conclusion of our Phase II study, we will have validated the mechanical properties and surgical implantation procedure for the EndoOrthopaedics TABI device. As we conclude this project, we will translate our study results into regulatory documents that we will use when seeking FDA approval to market our TABI fixation technology.

Public Health Relevance Statement:


Public Health Relevance:
The distal radius is one of the most common sites of bone fracture and is the most common fracture site in the upper extremity. Approximately 25% of patients (~80,000/year) require surgery to correctly repair this bone, although current treatments for this type of fracture require substantial disruption the soft tissues surrounding the joint. EndoOrthopaedics' fracture fixation technology (TABI) can be assembled by the surgeon entirely within the fracture during a minimally invasive procedure, which will limit patient discomfort and minimize soft tissue damage. The overall objective of this study is to validate the biomechanical performance and surgical efficiency of our device.

Project Terms:
Accounting; Adopted; Adoption; Adult; Affect; analog; Biomechanics; bone; Bone callus; Bone Regeneration; Cadaver; cantilever; Clinical; commercialization; cost; design; Devices; Distal; Documentation; Elements; Failure (biologic function); Feedback; Fracture; Fracture Fixation; Hand functions; haptics; Implant; implantable device; implantation; Implantation procedure; improved; Intramedullary Fracture Fixation; Joints; Lead; Ligaments; Marketing; Measures; Mechanics; Methods; minimally invasive; neuromuscular; Operative Surgical Procedures; Orthopedics; Osteotomy; Patients; Performance; Phase; phase 1 study; phase 2 study; Positioning Attribute; Postoperative Period; prevent; Procedures; Process; Property; public health relevance; Radial; repaired; Risk; sample fixation; Shapes; Simulate; Site; soft tissue; Surface; Surgeon; System; Tactile; Technology; Tendon structure; Time; Torsion (malposition); Translating; Translations; Treatment Cost; United States; Upper Extremity; Wrist; wrist fracture