The Clinical and Economic Impact of Generic Locking Plate Utilization at a Level II Trauma Center

Abstract

Therapeutic Level III.

Finite element analysis of locking plate and 1/4 tubular plate for first tarsometatarsal joint fracture-dislocation

“…Furthermore, a locking plate may cost more than a 1/4 tubular plate in many developing countries. 18 , 19 Therefore, fixation of first TMT joint fracture-dislocation using a 1/4 tubular plate is more suitable than using a locking plate with respect to both biomechanical and economical factors and can be widely used in the clinical setting.…”

Policy and ethical considerations for widespread utilization of generic orthopedic implants

“…A study by McPhillamy et al explored use of generic implants compared to conventional implants in 828 patients. The hospital realized a 56% reduction in implant costs and $458,080 in total savings for the study period and clinical outcomes were equivalent [9] . A retrospective study in 2014 by Althausen et al [10] similarly showed no differences in clinical outcomes for patients with femoral neck fractures or posterior pelvic ring injuries managed with generic implants compared to conventional implants and a 70% reduction in implant costs was observed.…”

“…However, there have been well-documented cases of approved implants causing significant harm to patients. Although several studies have demonstrated the equivalence of quality between certain generic and brand name orthopedic implants, concerns regarding small put potentially harmful differences in manufacturing practices and the potential for disparate use of generic implants in economically disadvantaged patients raise ethical questions [9] , [10] . If generic orthopedic implants were found to have even a minor measurable negative impact on surgical outcomes, this would be a profound violation of the principles of nonmaleficence and the “difference principle” of justice, described by Rawls, that declares inequalities are only permitted if the conditions dictated ultimately benefit, not harm, the worst-off [20] .…”

“…To that end, as patents on many brand name implants begin to expire, “generic” implants present a unique opportunity to improve the value of orthopedic care. Although generic drugs have been used for decades in the pharmaceutical industry, the use of generic implants has only recently been considered in the field of orthopedic surgery [8] , [9] , [10] . In the pharmaceutical sector, an estimated $33 billion has been saved by Medicare in the United States through utilization of generic medications [11] .…”

“…There is some literature describing the favorable economic possibilities for use of generic orthopedic implants [9] , [10] , [12] . However, the ethical issues, policy implications, and potential unanticipated consequences of such a paradigm shift have not been investigated.…”