Abstract

This developmental project seeks to facilitate early detection of serious complications associated with new orthopedic devices. Innovative aspects of the project include validation of administratively-derived safety measures, use of FDA-approval data as a benchmark for monitoring safety, and use of readily-available population-based databases to evaluate the safety of emerging surgical devices. The project implements statistical modeling techniques that leverage medical claims data to continually assess the risks of new devices as additional data is accured on repeat surgery, infection, other complications, and death. We will demonstrate the approach by examining the experience with bone morphogenetic protein, a biological agent used as an adjuncent to spinal fusion surgery

Public Health Relevance

Timely reporting of safety data for new devices could reduce complications, help clinicians and patients make informed decisions about whether to undergo orthopaedic surgery and what types of surgical devices to use.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Comprehensive Center (P60)
Project #
5P60AR062799-02
Application #
8500223
Study Section
Special Emphasis Panel (ZAR1-KM)
Project Start
Project End
Budget Start
2013-09-01
Budget End
2014-08-31
Support Year
2
Fiscal Year
2013
Total Cost
$81,641
Indirect Cost
$31,698

  Institution

Name
Dartmouth College
Department
Type
DUNS #
041027822
City
Hanover
State
NH
Country
United States
Zip Code
03755

  Publications

Marfeo, Elizabeth E; Ni, Pengsheng; McDonough, Christine et al. (2018) Improving Assessment of Work Related Mental Health Function Using the Work Disability Functional Assessment Battery (WD-FAB). J Occup Rehabil 28:190-199
Moulton, Haley; Tosteson, Tor D; Zhao, Wenyan et al. (2018) Considering Spine Surgery: A Web-Based Calculator for Communicating Estimates of Personalized Treatment Outcomes. Spine (Phila Pa 1976) 43:1731-1738
Abdu, William A; Sacks, Olivia A; Tosteson, Anna N A et al. (2018) Long-Term Results of Surgery Compared With Nonoperative Treatment for Lumbar Degenerative Spondylolisthesis in the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976) 43:1619-1630
Klare, Christian M; Fortney, Thomas A; Kahng, Peter W et al. (2018) Prognostic Factors for Success After Irrigation and Debridement With Modular Component Exchange for Infected Total Knee Arthroplasty. J Arthroplasty 33:2240-2245
Tapp, Stephanie J; Martin, Brook I; Tosteson, Tor D et al. (2018) Understanding the value of minimally invasive procedures for the treatment of lumbar spinal stenosis: the case of interspinous spacer devices. Spine J 18:584-592
Skolasky, Richard L; Scherer, Emily A; Wegener, Stephen T et al. (2018) Does reduction in sciatica symptoms precede improvement in disability and physical health among those treated surgically for intervertebral disc herniation? Analysis of temporal patterns in data from the Spine Patient Outcomes Research Trial. Spine J 18:1318-1324
Munson, J C; Bynum, J P W; Bell, J-E et al. (2018) Impact of prescription drugs on second fragility fractures among US Medicare patients. Osteoporos Int 29:2771-2779
Martin, Brook I; Lurie, Jon D; Farrokhi, Farrokh R et al. (2018) Early Effects of Medicare's Bundled Payment for Care Improvement Program for Lumbar Fusion. Spine (Phila Pa 1976) 43:705-711
Passias, Peter G; Poorman, Gregory; Lurie, Jon et al. (2018) Patient Profiling Can Identify Spondylolisthesis Patients at Risk for Conversion from Nonoperative to Operative Treatment. JB JS Open Access 3:e0051
Patel, Neel K; Moses, Rachel A; Martin, Brook I et al. (2017) Validation of Using Claims Data to Measure Safety of Lumbar Fusion Surgery. Spine (Phila Pa 1976) 42:682-691

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