Ongoing Projects

The Weill Cornell CERT applies the tools of outcomes research, technology assessment, and medical economics to evaluate medical and orthopedic devices. Core projects currently under way are included in the first table below; pilot projects are summarized in the second and third tables.

Project Name Project Description Anticipated Impact Investigators
Prospective evaluation of the clinical and economic outcomes of total joint replacement: The CERT joint replacement registry
See HSS CERT page to report your progress 6 months after surgery
The purpose of this study is to establish a prospective cohort with extensive data on clinical outcomes for patients undergoing total joint replacements. It is expected that a number of studies will emerge from this data relating to patient, device, and surgical approach variations and their impact on patient-centered outcomes.
Registry brochure
April 2008 newsletter
These studies will provide data to allow patients, physicians, and policy makers to better utilize total joint replacement surgeries. Lisa Mandl, MD, MPH;
Robert Marx, MD, MSc;
Alvin Mushlin, MD, ScM;
Thomas Sculco, MD
Volume outcomes relationship in the use of ICDs This is a retrospective study of complication rates and mortality for patients undergoing automatic implantable cardioverter-defibrillator (ICD) placement. We are interested in the relationship between volume of procedures done by the responsible physician and complications and mortality rates for the patients receiving the procedures. This study will provide information to patients and policy makers on the relationship between volume of ICD replacements and complications/mortality in order to help in decisions on where best to refer patients for these expensive procedures. Stephen Lyman, PhD
Outcome variations for total joint replacement based on volume and region This study will analyze Healthcare Cost and Utilization Project (HCUP) data from sixteen states to examine the impact of a center of excellence approach to utilization of complex medical devices. The study would include a focus on expected quality improvements nationwide as well as issues of patient impact such as access to services for a variety of subpopulations. Results from this study will inform policy on the benefits and possible unintended consequences of the center of excellence approach in terms of medical device procedures across the nation. Stephen Lyman, PhD;
Madhu Mazumdar, PhD

Pilot Projects Fiscal Year 2

Project Name Project Description Anticipated Impact Investigators
Improving the clinical performance of total elbow replacements Mechanical problems are leading causes of poor outcomes in cases of elbow replacement. This study will examine a large number of retrieved elbow replacements to assess wear and damage on the basis of type, severity, and location on the components. The results will be preliminary to a study intended to combine patient kinetics with a computational elbow model to determine joint loads. The goal is to improve performance through rational design changes based on understanding expected failure mechanisms. Timothy Wright, PhD; Mark Figgie, MD; Robert Hotchkiss, MD
Assessing the performance of a new pain measurement instrument in patients undergoing total joint arthroplasty This study will utilize the HSS/CERT joint registry to evaluate the reliability and validity of the "I COAP" pain outcome instrument in patients undergoing total knee and total hip replacement. The I COAP is designed to provide patient-reported outcome data which would help investigators and clinicians decide when there is a need for joint replacement. Establishing I COAP as a benchmark would be useful in evaluation of treatment response to disease-modifying drugs in OA clinical trials. Lisa A. Mandl, MD, MPH; Robert Marx, MD, MSc; Stephen Lyman, PhD; Gillian Hawker, MD
National trends in the utilization of knee and hip arthroplasties: a study of difference in uptake by age and ethnicity using HCUP-NIS database This study examines disparities in the delivery of care to patients with rheumatologic and musculoskeletal (orthopedic) conditions using the Healthcare Cost and Utilization Project National Inpatient State (HCUP-NIS). This study would provide evidence toward success of the efforts made in abolishing the ethnic gap of utilization of knee replacement procedures. It also would provide knowledge of the characteristics of younger patients needing this procedure in the future. Heejung Bang, PhD; Madhu Mazumdar, PhD
Pilot evaluation of the cost effectiveness of accelerated partial breast irradiation using MammoSiteTM in Early Breast Cancer Patients The specific aim of this study is to pilot a cost-effectiveness analysis, using a simulation model, of MammoSiteTM compared to whole breast radiation therapy (WBRT) to control disease and prevent subsequent events. The hypothesis is that MammoSiteTM is more expensive initially, but leads to better outcomes and lower long-term costs when compared to WBRT in current use. The expected impact of these data is to inform appropriate, cost-effective utilization of new technology. Heather Taffet Gold, PhD; Mary Katherine Hayes, MD

Pilot Projects Fiscal Year 3

Project Name Project Description Anticipated Impact Investigators
Improvement in sample size calculation for cluster-randomized trials The goal of this project is to improve upon the Simple sample size calculation for CRT published in International Journal of Epidemiology (1999) that is widely utilized in cluster randomized trials. The findings from this study will yield a more accurate sample size calculation mechanisms. Majnu John, PhD; Madhu Mazumdar, PhD; Alison Edwards, MStat
Feasibility of registry merger between CERT and CORRe Hip Knee Registries The CORRe hip and knee registry at HSS was established in December 2002 to monitor clinical performance of joint replacements. The goal of this project is to investigate the software requirements needed to allow the CORRe and the CERT joint registry to exchange information and complement one another. Linking these two data sources would allow for an augmentation of the infrastructure for research on joint replacement. Douglas E. Padgett, MD; Lisa Mandl, MD; Kristen Foote, MS; Stephen Lyman, PhD
Assessment of radiation-induced fibrosis (RIF) with tissue compliance meter (TCM) in patients with early stage breast cancer treated with Mammosite Brachytherapy: implications for studying fibrosis in breast cancer survivors The project will explore whether TCM can serve as a non-invasive modality for early detection of RIF in patients with early stage breast cancer treated with MammoSite brachytherapy. If successful, it would lead to significant improvement in management of patients with breast cancers with enromous potential to improve patient outcome and quality of life. A. Gabriella Wernicke, MD; Bhupesh Parashar, MB,BS, MD; Mary K. Hayes, MD; Dattatreyudu Nori, MB,BS, MD; KS. Clifford Chao, MD
Differences in gender, age, preoperative pain, and living situation between patients undergoing total knee arthroplasty and patients undergoing total hip arthroplasty Using prospective institutional total knee replacement (TKR) and total hip replacement (THR) to determine whether there are gender and age differences in outcomes. The findings from this study will help researchers be more aware of differences between patients who elect TKR and THR, and improve clinical pathways and patient satisfaction. Geoffrey Westrich, MD; Madhu Mazumdar, PhD; Lindsey Bornstein; John Rutledge, MAS; Lisa Mandl, MD, MPH

Pilot Projects Fiscal Year 4

Project Name Project Description Anticipated Impact Investigators
A population-based assessment of risks associated with central venous catheters for administration of chemotherapy in patients with Hodgkin and non-Hodgkin lymphoma     Peter Martin, MD, MS
Bayesian design and analysis of clinical trials with multiple outcomes and small sample size     Stefano Monni, PhD
Association between social support, mental health, physical status and pain in patients preceding total hip replacement     Lisa Mandl, MD, MPH
Short term complications associated with total hip and knee arthroplasty     Geoffrey Westrich, MD

THA X-Ray of THA
Hip Joint X-Ray of Hip Joint
THA X-Ray Of Arthrtic Hip
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