Policy and ethical considerations for widespread utilization of generic orthopedic implants

Pean, Christian A.; Lajam, Claudette M.; Zuckerman, Joseph D.; Bosco, Joseph

doi:10.1016/j.artd.2019.02.007

Cited by 8 publications

(18 citation statements)

References 28 publications

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“…Confidentiality clauses are used as the supplier may not offer similar discounts between different hospital systems in the same region. 5 An increased incidence in post-operative infection rate was observed in the conventional group. Two of the four infections occurred in patients who had a history of metastatic cancer and previous chemotherapy.…”

Section: Discussionmentioning

confidence: 94%

“…process and sold at lower cost. 5 Negative perceptions have been associated with generic implants because the term has previously been used in reference to remaindered implants and discounted stock by the manufacturer to maintain market share. 5,6 The earliest equivalence study of generic orthopaedic implants found no difference in clinical outcomes in total hip arthroplasty while showing notable cost savings.…”

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confidence: 99%

“…5 Negative perceptions have been associated with generic implants because the term has previously been used in reference to remaindered implants and discounted stock by the manufacturer to maintain market share. 5,6 The earliest equivalence study of generic orthopaedic implants found no difference in clinical outcomes in total hip arthroplasty while showing notable cost savings. 6 Another study showed a difference in generic total hip arthroplasty implant structure and surface properties but did not the investigate clinical outcomes.…”

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confidence: 99%

See 2 more Smart Citations

Outcomes and Cost Comparison Between Generic and Conventional Cephalomedullary Nails in the Treatment of Peritrochanteric Femur Fractures

Khoo

Kim

Lindvall

et al. 2021

J Am Acad Orthop Surg

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Introduction: Although generic orthopaedic implants have been available for several years, there has been slow adoption of this costsaving option. We hypothesize equivalent outcomes between generic and conventional cephalomedullary nails (CMN) in the treatment of peritrochanteric femur fractures. Methods: We evaluated 419 patients undergoing CMN for peritrochanteric femur fracture with a minimum 6-month follow-up. Demographic data, radiographic assessment, and clinical outcomes were compared. Results: Ninety patients were treated with generic implants and 329 patients with conventional implants. The overall complication rate was 7.0%, with a revision surgery rate of 5.4%. No significant differences were seen in demographic variables or surgical factors. Although there was an increased incidence of postoperative infections with conventional nails (P = 0.045), no significant differences were seen in other complications. Conclusion: At our institution, generic nails cost approximately 38% less than their conventional counterparts. There seems to be no increased rate of implant-associated complications with the use of generic CMNs, although allowing for notable cost savings. Healthcare expenditure in the United States continues to increase. In 2018, expenditures increased by 4.6% to an estimated $3.6 trillion. 1 Implantable medical devices represent approximately 4% to 6% of the total healthcare expenditure. 2 The orthopaedic trauma implant market is valued at more than $5.3 billion annually and projected to continue rising. 3,4 As a result, there have been efforts to drive implant cost savings through bundled payment plans, decreasing reimbursements and group purchasing organizations. "Generic" orthopaedic implants have allowed for an additional cost savings approach; however, few studies exist that have investigated the efficacy of these implants. The term generic implant generally refers to implants that have been developed primarily through the 510(k) predicate

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Section: Discussionmentioning

confidence: 94%

mentioning

confidence: 99%

mentioning

confidence: 99%

See 1 more Smart Citation

Outcomes and Cost Comparison Between Generic and Conventional Cephalomedullary Nails in the Treatment of Peritrochanteric Femur Fractures

Khoo

Kim

Lindvall

et al. 2021

J Am Acad Orthop Surg

View full text Add to dashboard Cite

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“…Arthroplasty Today has published our first 2 Viewpoint manuscripts in the June 2019 [1] and September 2019 [2] editions.…”

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confidence: 99%

“…The paper by Pean et al [1], in the June edition, “Policy and ethical considerations for the widespread utilization of generic orthopedic implants,” represents a “pro and con” manuscript reviewing the use of generic implants as a strategy to decrease implant expenditures in orthopedics. The authors present a detailed analysis of the economic, ethical, and regulatory factors that ought to be considered in a decision to introduce generic implants.…”

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confidence: 99%