: Medical devices have been associated with some of the most significant therapeutic advances in medicine in the last decades, leading to many improvements in life expectancy and quality of life for patients with musculoskeletal, cardiac, and other diseases. However, there are enormous cost implications for Medicare and for other government and private health insurers. To address the need for clinical and economic studies to help clinicians, regulators, and payers make decisions about how best to use these devices, we propose a Center for Education and Research on Therapeutics with a focus on therapeutic medical devices. Our proposal combines the research experience and resources of the Department of Public Health at Weill Medical College of Cornell University with the Hospital for Special Surgery (HSS), the largest and one of the most well-respected orthopedic institutions in the country. The proposed CERT will have particular strength and focus in prosthetic orthopedic devices through HSS, and will add geographic diversity through a partnership with The Methodist Hospital in Houston, Texas. Additionally, the New York Presbyterian Healthcare System, which includes hospitals in highly diverse communities in the NY Metro region, provides a ready laboratory for conducting multi-center studies on therapeutic medical devices, for inclusion of disadvantaged populations, and for dissemination of research findings. Additionally, a number of clinical disciplines within the Cornell community have pledged interest in evaluating medical devices outside of the orthopedic arena in collaboration with the proposed CERT. The CERT will be organized into five cores: outcomes, clinical, health economics, dissemination and education, and data management and biostatistics in order to support the mission of the CERT. A strong focus on dissemination to patients, providers, and policy-makers is included in the proposal, with a particular emphasis on ensuring that culturally appropriate educational materials are developed. Two initial studies are included in this proposal: one evaluating predictors of total hip replacement failure (between 8 -18% of hip replacements require revision due to failure) and a second study evaluating the impact on patients of proposals to regionalize total joint replacement surgeries. Funding for pilot studies of other medical devices is included in the CERT, with several pilots described. Evaluating the clinical and economic impact of therapeutic medical devices will improve the use of devices. As the population ages, and as new technologies develop, patients, physicians, and policy-makers require information on how these devices impact the health of the public in order to make informed decisions.

National Institute of Health (NIH)
Agency for Healthcare Research and Quality (AHRQ)
Research Demonstration--Cooperative Agreements (U18)
Project #
Application #
Study Section
Special Emphasis Panel (ZHS1-HSR-O (01))
Program Officer
Kelly, Carmen
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Weill Medical College of Cornell University
Public Health & Prev Medicine
Schools of Medicine
New York
United States
Zip Code
D'Apuzzo, Michele; Westrich, Geoffrey; Hidaka, Chisa et al. (2017) All-Cause Versus Complication-Specific Readmission Following Total Knee Arthroplasty. J Bone Joint Surg Am 99:1093-1103
Moussa, Mohamed E; Lee, Yuo-Yu; Westrich, Geoffrey H et al. (2017) Comparison of Revision Rates of Non-modular Constrained Versus Posterior Stabilized Total Knee Arthroplasty: a Propensity Score Matched Cohort Study. HSS J 13:61-65
Mandl, Lisa A; Zhu, Rebecca; Huang, Wei-Ti et al. (2016) Short-Term Total Hip Arthroplasty Outcomes in Patients With Psoriatic Arthritis or Psoriatic Skin Disease Compared to Patients With Osteoarthritis. Arthritis Rheumatol 68:410-7
Goodman, Susan M; Mandl, Lisa A; Parks, Michael L et al. (2016) Disparities in TKA Outcomes: Census Tract Data Show Interactions Between Race and Poverty. Clin Orthop Relat Res 474:1986-95
Roberts, Jordan E; Mandl, Lisa A; Su, Edwin P et al. (2016) Patients with Systemic Lupus Erythematosus Have Increased Risk of Short-term Adverse Events after Total Hip Arthroplasty. J Rheumatol 43:1498-502
Goodman, Susan M; Johnson, Beverly; Zhang, Meng et al. (2016) Patients with Rheumatoid Arthritis have Similar Excellent Outcomes after Total Knee Replacement Compared with Patients with Osteoarthritis. J Rheumatol 43:46-53
Lynch, T Sean; Parker, Richard D; Patel, Ronak M et al. (2015) The Impact of the Multicenter Orthopaedic Outcomes Network (MOON) Research on Anterior Cruciate Ligament Reconstruction and Orthopaedic Practice. J Am Acad Orthop Surg 23:154-63
Wasserstein, D; Huston, L J; Nwosu, S et al. (2015) KOOS pain as a marker for significant knee pain two and six years after primary ACL reconstruction: a Multicenter Orthopaedic Outcomes Network (MOON) prospective longitudinal cohort study. Osteoarthritis Cartilage 23:1674-84
Dy, Christopher J; Marx, Robert G; Ghomrawi, Hassan M K et al. (2015) The potential influence of regionalization strategies on delivery of care for elective total joint arthroplasty. J Arthroplasty 30:1-6
LoVerde, Zachary J; Mandl, Lisa A; Johnson, Beverly K et al. (2015) Rheumatoid Arthritis Does Not Increase Risk of Short-term Adverse Events after Total Knee Arthroplasty: A Retrospective Case-control Study. J Rheumatol 42:1123-30

Showing the most recent 10 out of 44 publications