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Additive Manufactured PEKK Implants for Small Bone Arthroplasty

Award Number: R41AR076303
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/16/2019
PERIOD OF PERFORMANCE END DATE: 11/30/2020

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Additive Manufactured PEKK Implants for Small Bone Arthroplasty - ABSTRACT This Phase I STTR is designed to evaluate the feasibility of using the OsteoFab® technology platform for joint arthroplasty (ArthroFab™) devices, specifically targeting replacement of the small carpal bones in the wrist and hemiarthroplasty. OsteoFab® technology is the combination of Oxford Performance Materials' proprietary formulation of polyetherketoneketone (OXPEKK® polymer) and additive manufacturing (3D printing). This STTR builds on an existing collaboration between Dr. Joseph Crisco and his team in the Department of Orthopaedics at the Warren Alpert Medical School of Brown University/Rhode Island Hospital, and Oxford Performance Materials, Inc. (OPM), a small business in South Windsor, CT that is a world leader in bone replacements using 3D additive manufacturing. OPM currently markets FDA-cleared patient-specific devices for cranial and facial bone reconstruction (OsteoFab®) and holds a clearance for a vertebral body replacement system (SpineFab®) worldwide. However, the performance of OPM's OsteoFab® devices has not yet been investigated in synovial joints, nor in direct articulation with cartilage. In this project we will assess the feasibility of using the OsteoFab® manufacturing process to fabricate small articulating bone replacements. We propose two independent specific aims. In our first Aim we will use an established lunate resection model in the rabbit forepaw to evaluate cartilage health, local inflammation, and bony changes after 12 weeks of OsteoFab® arthroplasty. The ArthoFab™-Lunate device will be fabricated and finished by OPM, based on an average lunate bone model generated using our well-established computational and morphological modeling algorithms. The average lunate will be 3D printed in laser-sintered OXPEKK® polymer and the articular surfaces will be polished, with features for soft tissue attachment. Six (6) animals will receive ArthoFab™-Lunate devices and six will undergo lunate excision alone. In our second Aim, we will assess in vitro cartilage wear response to cyclic loading in a hemiarthroplasty model via pendulum testing (136,800 cycles). 3D models of the rabbit knee will be used to fabricate articulating ArthoFab™-Tibia models. Explanted fresh rabbit distal femur condyles will be flexed and extended against the ArthoFab™ tibial devices with a compressive load of 1 kg at 1 Hz for 38 hours. Cartilage damage will be determined with histopathology after 14 (n=9) and 38 (n=9) hours of cyclic testing. Changes in joint mechanics will be assessed by coefficient of friction (COF) measurements at 0, 2, 14, 26 and 38 hours of testing. The work outlined in this Phase I STTR will provide critical feasibility data for the development of a research strategy for commercialization of ArthroFab™ as a highly innovative, additively manufactured patient-specific device for small bone arthroplasty and hemiarthroplasty, with the potential for a significant impact on the surgical treatment of osteoarthritis and en bloc tumor resections.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2022 ( Subtotal = $29,197 )
2022	2019	OXFORD PERFORMANCE MATERIALS, INC.	30 S SATELLITE RD	SOUTH WINDSOR	CT	06074	CAPITOL	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	1	11/22/2021	NEW	$0
2022	2019	OXFORD PERFORMANCE MATERIALS, INC.	30 S SATELLITE RD	SOUTH WINDSOR	CT	06074	CAPITOL	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	11/16/2021	NEW	$29,197
														Subtotal = $29,197

Issue Date FY: 2021 ( Subtotal = -$29,197 )
2021	2019	OXFORD PERFORMANCE MATERIALS, INC.	30 S SATELLITE RD	SOUTH WINDSOR	CT	06074	CAPITOL	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	11/23/2020	NEW	$0
2021	2019	OXFORD PERFORMANCE MATERIALS, INC.	30 S SATELLITE RD	SOUTH WINDSOR	CT	06074	CAPITOL	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	1	2/4/2021	NEW	-$29,197
														Subtotal = -$29,197

Issue Date FY: 2019 ( Subtotal = $202,364 )
2019	2019	OXFORD PERFORMANCE MATERIALS, INC.	30 S SATELLITE RD	SOUTH WINDSOR	CT	06074	CAPITOL	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	9/16/2019	NEW	$202,364
														Subtotal = $202,364

Grand Total All Awards = $202,364

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Additive Manufactured PEKK Implants for Small Bone Arthroplasty

Award Number: R41AR076303

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/16/2019

PERIOD OF PERFORMANCE END DATE: 11/30/2020

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