Antimicrobial-releasing gels for preventing infection in total joint arthroplasty

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R41AR064080-01
Agency Tracking Number: R41AR064080
Amount: $149,991.00
Phase: Phase I
Program: STTR
Awards Year: 2013
Solicitation Year: 2013
Solicitation Topic Code: NIAMS
Solicitation Number: PA12-089
Small Business Information
3931 W BUTLER ST, CHANDLER, AZ, 85226-3865
DUNS: 78413884
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (480) 965-0929
Business Contact
Phone: (216) 926-2193
Research Institution
TEMPE, AZ, 85287-6011
 () -
 Nonprofit college or university
DESCRIPTION (provided by applicant): Orthopaedic Surgical Site Infections (SSIs), including Prosthetic Joint Infections (PJIs), are an extremely costly health care problem, illustrated by the 70,000- 114,000 average total cost per case to treat more than20,000 hip and knee replacement infections in the US each year. When a prosthetic joint becomes infected following arthroplasty, organisms form a biofilm on the prosthesis and become inaccessible to systemically delivered antibiotics or immune cells. There is no available option for antimicrobial delivery over the entire surface of a prosthetic joint that is press-fit directly into a bony implantation site, as the vast majority of implants are. Such a technology would provide a real benefit to patients andcould decrease the current costs of treating these infections by approximately 2,000,000,000 per year. A promising approach for preventing infections following joint replacement is to use reasorbable in situ forming gels for the sustained release of antimicrobial drugs. These new gels offer the following advantages for improved prevention of prosthetic joint infections: 1) efficient and sustained antibiotic release; 2) soft yet cohesive physical structure allowing for complete surface coverage and preventing the development of biofilm in isolated crevasses, and 3) rapid degradability allowing for normal bone healing, fixing the implant in place. The goal of the proposed work is to generate critical in vivo safety and efficacy data to support future investment in pre-clinical and clinical trials on these new, synthetic, and fully resorbable antimicrobial-releasing gels. To do this, in situ forming hydrogels will be evaluated with respect to their safety and two clinically relevant outcomes-the quality ofbone healing through the gel site and the efficacy of antibiotic-loaded gels in preventing infection on press-fit metal implants. Bone healing through the gel site will be evaluated by histology and load frame testing in a rabbit cancellous bone press-fitimplant model. The efficacy in preventing infection will be evaluated by press-fitting textured metal implants subjected to S. aureus into a void in cancellous bone pre-filled with antimicrobial- loaded gels. Successful completion of the proposed work will provide clinically relevant proof-of- principle data regarding the safety and efficacy of these hydrogels and in particular their use on the surface of orthopaedic implants. This data will immediately be used to lead to a pre-IND meeting with the FDA andwill attract future investment for the commercialization of this new drug product. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Infections of replacement knees and hips cost the U.S. healthcare system approximately 2,000,000,000 per year.Using new materials which can deliver antimicrobial drugs directly at the surface of joint replacements will lead to dramatically reduced infection rates and save our healthcare system hundreds of millions of dollars per year.

* information listed above is at the time of submission.

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