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Load Bearing 3D Printed Implants for Antibiotic, Cell and Growth Factory Delivery

Award Number: R03AR066366
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: 09/12/2014
PERIOD OF PERFORMANCE END DATE: 08/31/2018

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Load Bearing 3D Printed Implants for Antibiotic, Cell and Growth Factory Delivery - DESCRIPTION (provided by applicant): The goal of this proposal is to improve the treatment for infections of artificial hips and knees and other im- planted devices. This multidisciplinary proposal involves established and productive experts in infectious dis- ease, orthopaedic surgery, chemical engineering, fluid dynamics and biomedical engineering from the Dept. of Orthopaedics at the Massachusetts General Hospital (MGH), Harvard Medical School and the School of Engi- neering and Applied Sciences at Harvard University. In this proposal, a new approach that could fundamental- ly change the treatment of device related infections will be evaluated. The long term goal of this work is to de- velop improved methods to reduce the treatment time required for eradicating peri-prosthetic infections. The particular objectives in ths application are to validate a perfusible load bearing 3D printed PEKK polymer for the controlled and sustained local delivery of antibiotics at high peri-implant doses. To achieve this objective, 3D printed polymer rods containing channels for the delivery of fluids will be implanted into the femora of rab- bits that have been inoculated with Staph Aureus. The vancomycin concentration in the medullary canal, joint space and systemic circulation will be determined as well as the presence or absence of infection. Levels of vancomycin will be determined by ELISA based assays. Changes in bone morphology, tissue response and infection status will be determined by radiography, histology and microbiological culture. The central hypothe- sis is that local antibiotic delivery to the peri-implant space can eradicate an established infection in a short pe- riod of time. The rationale for the proposed pilot study is that perfusion enables a broader use of ABx and greatly improved control of local ABx concentrations than ABx elution from PMMA. These advances could re- duce treatment time for TJI from months to weeks. The result of Aim 1 will be a load bearing knee spacer ca- pable of maintaining high levels of vancomycin in the peri-implant space (medullary canal and joint space). The result of Aim 2 will be validation that a femoral rod that can eradicate infection by perfusion of vancomycin. The result of Aim 3 will be validation that a load bearing knee spacer that can eradicate infection by perfusion of vancomycin. The proposed research is innovative because it combines load-bearing implantable materials with the simplicity and flexibility of a perfusible drug delivery system. The proposed research is significant be- cause infection is a burdensome clinical issue that results in prolonged patient suffering, increased mortality and is expected to cost $12 billion USD/yr by 2015. The impact of this study is the potential to rapidly advance treatment for bone and joint infections, reduce healthcare costs and reduce patient suffering.


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: 2019 ( Subtotal = $0 )
2019	2017	OXFORD PERFORMANCE MATERIALS, INC.	30 S SATELLITE RD	SOUTH WINDSOR	CT	06074	CAPITOL	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	12/31/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $0 )
2018	2017	OXFORD PERFORMANCE MATERIALS, INC.	30 S SATELLITE RD	SOUTH WINDSOR	CT	06074	CAPITOL	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	4/20/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $1 )
2017	2017	OXFORD PERFORMANCE MATERIALS, INC.	30 S SATELLITE RD	SOUTH WINDSOR	CT	06074	CAPITOL	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	3	9/14/2017	NON-COMPETING CONTINUATION	$1
2017	2015	OXFORD PERFORMANCE MATERIALS, INC.	30 S SATELLITE RD	SOUTH WINDSOR	CT	06074	CAPITOL	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	7/7/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $1

Issue Date FY: 2016 ( Subtotal = $0 )
2016	2015	OXFORD PERFORMANCE MATERIALS, INC.	OXFORD PERFORMANCE MATERIALS	SOUTH WINDSOR	CT	06074	CAPITOL	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	8/23/2016	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2015 ( Subtotal = $83,300 )
2015	2015	OXFORD PERFORMANCE MATERIALS, INC.	OXFORD PERFORMANCE MATERIALS	SOUTH WINDSOR	CT	06074	CAPITOL	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	8/20/2015	NON-COMPETING CONTINUATION	$83,300
														Subtotal = $83,300

Issue Date FY: 2014 ( Subtotal = $83,300 )
2014	2014	OXFORD PERFORMANCE MATERIALS, INC.	OXFORD PERFORMANCE MATERIALS	SOUTH WINDSOR	CT	06074	CAPITOL	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	9/12/2014	NEW	$83,300
														Subtotal = $83,300

Grand Total All Awards = $166,601

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Load Bearing 3D Printed Implants for Antibiotic, Cell and Growth Factory Delivery

Award Number: R03AR066366

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: 09/12/2014

PERIOD OF PERFORMANCE END DATE: 08/31/2018

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