Craniomaxillafacial (CMF) reconstruction remains a significant challenge due to the complex geometry and the need to restore both esthetics and function, especially for large mandibular segmental defects resulting from tumor resection, trauma or congenital defects. The current clinical gold standard, vascularized free bone flap (VBF), still suffers significant drawbacks. Among these are the inability to restore defect geometry, the inability to restore complete mandibular function, and the significant surgical and functional morbidity associated with harvesting the graft. Indeed this surgical morbidity precludes the use of VBF in some patients. The ability to create a customized, functional and degradable synthetic scaffold that would enhance tissue regeneration would be a significant advance in CMF reconstruction in general and mandibular reconstruction specifically. The specific focus of this phase I SBIR is to demonstrate the feasibility of designing, manufacturing and placement of an osteoconductive coating customized for mandibular reconstruction scaffolds directly from patient image data. We will specifically show that scaffolds capable of withstanding functional masticatory loads can be reproducibly manufactured and osteoconductively coated directly from patient specific CT scans. We will create these scaffolds directly from domestic pig, macaca fasicicularis monkey, and human patient CT data. A phase II SBIR testing these scaffolds in both the domestic pig and Macaca fasicicularis monkey would follow on to demonstrate both functional and regenerative capability of these scaffolds in large functional animals models, leading to an eventual clinical trial.
Public Health Relevance: Repair of damage and deformity of the bones in the face and head is problematic because both aesthetics and function must be restored. TRS now has the capability to take patient specific anatomical data from CT scans and design and manufacture custom implants to repair and regenerate damaged tissue. Successful clinical introduction of these implants would allow patients to receive degradable scaffolds that mimic the contours of their own bone, can bear the mechanical forces of chewing, and encourage the growth of new tissue. Thus, patients could be spared the risk of autografts and still obtain immediate return of aesthetic and mechanical function. Long term, the degradable implant will be totally replaced by native bone.
Public Health Relevance Statement: Project Narrative Repair of damage and deformity of the bones in the face and head is problematic because both aesthetics and function must be restored. TRS now has the capability to take patient specific anatomical data from CT scans and design and manufacture custom implants to repair and regenerate damaged tissue. Successful clinical introduction of these implants would allow patients to receive degradable scaffolds that mimic the contours of their own bone, can bear the mechanical forces of chewing, and encourage the growth of new tissue. Thus, patients could be spared the risk of autografts and still obtain immediate return of aesthetic and mechanical function. Long term, the degradable implant will be totally replaced by native bone.
Project Terms: 4H3 protein; Abscission; Anatomic; Anatomic Abnormality; Anatomical Abnormality; Anatomical Sciences; Anatomy; Animal Model; Animal Models and Related Studies; Animals; Area; Au element; Autograft; Autologous Transplantation; Autotransplant; Bears; Birth Defects; Bite Force; Body Tissues; Bone; Bone Regeneration; Bone and Bones; Bones and Bone Tissue; CAT Scan, X-Ray; CAT scan; CT X Ray; CT scan; Cancers; Chewing; Clinical; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Clinical Trials, Unspecified; Collaborations; Complex; Computed Tomography; Computerized Axial Tomography (Computerized Tomography); Computerized Tomography, X-Ray; Congenital Abnormality; Congenital Anatomic Abnormality; Congenital Anatomical Abnormality; Congenital Defects; Congenital Deformity; Congenital Malformation; Congenital or Acquired Anatomic Abnormality; Congenital or Acquired Anatomical Abnormality; Custom; Data; Defect; Deformity; Devices; Domestic Pig; EMI scan; Engineering; Engineerings; Esthetics; Excision; Extirpation; Face; Flaps; Flexibility; Foundations; Goals; Gold; Harvest; Head; High Resolution Computed Tomography; Human; Human, General; Image; Implant; Individual; Inferior Maxillary Bone; International; Island Flaps; Load-Bearing; Loadbearing; Macaca; Macaque; Malignant Neoplasms; Malignant Tumor; Man (Taxonomy); Man, Modern; Mandible; Mandibular Scaffold; Marketing; Mastication; Masticatory Force; Mechanics; Medical Device; Microscopy, Electron, Scanning; Molecular Genetic Abnormality; Monkeys; Morbidity; Morbidity - disease rate; Natural regeneration; Occlusal Force; Operation; Operative Procedures; Operative Surgical Procedures; Oral; Patients; Permeability; Phase; Pig, Domestic; Pliability; Position; Positioning Attribute; Process; Regeneration; Relative; Relative (related person); Removal; Reporting; Risk; SBIR; SBIRS (R43/44); Scanning; Science of Anatomy; Simulate; Small Business Innovation Research; Small Business Innovation Research Grant; Structure; Surface; Surgeon; Surgical; Surgical Flaps; Surgical Interventions; Surgical Procedure; Surgical Removal; Sus scrofa domestica; System; System, LOINC Axis 4; Testing; Time; Tissues; Tomodensitometry; Tomography, Xray Computed; Transplantation, Autologous; Trauma; Ursidae; Ursidae Family; Weight-Bearing; Weight-Bearing state; Weightbearing; X-Ray Computed Tomography; anatomy; bite strength; bone; bone repair; catscan; clinical investigation; clinical relevance; clinically relevant; computed axial tomography; computerized axial tomography; computerized tomography; craniofacial; craniofacial complex; craniofacies; design; designing; facial; imaging; in vivo; interest; malignancy; mandibular; manufacturing process; maxillofacial; mimecan; model organism; neoplasm/cancer; new growth; osteoglycin; osteoinductive factor; pre-clinical; preclinical; preclinical study; public health relevance; reconstruction; regenerate; regenerate new tissue; regenerating damaged tissue; regenerative; repair; repaired; resection; restoration; scaffold; scaffolding; skeletal tissue; surgery; tissue reconstruction; tissue regeneration; tumor
