Dataset Information

Placing a price on medical device innovation: the example of total knee arthroplasty.

ABSTRACT:

Background

Total knee arthroplasty (TKA) is common, effective, and cost-effective. Innovative implants promising reduced long-term failure at increased cost are under continual development. We sought to define the implant cost and performance thresholds under which innovative TKA implants are cost-effective.

Methods

We performed a cost-effectiveness analysis using a validated, published computer simulation model of knee osteoarthritis. Model inputs were derived using published literature, Medicare claims, and National Health and Nutrition Examination Survey data. We compared projected TKA implant survival, quality-adjusted life expectancy (QALE), lifetime costs, and cost-effectiveness (incremental cost-effectiveness ratios or ICERs) of standard versus innovative TKA implants. We assumed innovative implants offered 5-70% decreased long-term TKA failure rates at costs 20-400% increased above standard implants. We examined the impact of patient age, comorbidity, and potential increases in short-term failure on innovative implant cost-effectiveness.

Results

Implants offering ?50% decrease in long-term TKA failure at ?50% increased cost offered ICERs <$100,000 regardless of age or baseline comorbidity. An implant offering a 20% decrease in long-term failure at 50% increased cost provided ICERs <$150,000 per QALY gained only among healthy 50-59-year-olds. Increasing short-term failure, consistent with recent device failures, reduced cost-effectiveness across all groups. Increasing the baseline likelihood of long-term TKA failure among younger, healthier and more active individuals further enhanced innovative implant cost-effectiveness among younger patients.

Conclusions

Innovative implants must decrease actual TKA failure, not just radiographic wear, by 50-55% or more over standard implants to be broadly cost-effective. Comorbidity and remaining life span significantly affect innovative implant cost-effectiveness and should be considered in the development, approval and implementation of novel technologies, particularly in orthopedics. Model-based evaluations such as this offer valuable, unique insights for evaluating technological innovation in medical devices.

SUBMITTER: Suter LG

PROVIDER: S-EPMC3646021 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Publications

Placing a price on medical device innovation: the example of total knee arthroplasty.

Suter Lisa G LG Paltiel A David AD Rome Benjamin N BN Solomon Daniel H DH Thornhill Thomas S TS Abrams Stanley K SK Katz Jeffrey N JN Losina Elena E

PloS one 20130506 5

<h4>Background</h4>Total knee arthroplasty (TKA) is common, effective, and cost-effective. Innovative implants promising reduced long-term failure at increased cost are under continual development. We sought to define the implant cost and performance thresholds under which innovative TKA implants are cost-effective.<h4>Methods</h4>We performed a cost-effectiveness analysis using a validated, published computer simulation model of knee osteoarthritis. Model inputs were derived using published lit ...[more]

PMID: 23671626

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Project description:PurposeStability in the sagittal plane, particularly regarding anterior cruciate ligament compensation, and postoperative functionality and satisfaction remain issues in total knee arthroplasty. Therefore, this prospective study compared the clinical outcomes between medial-pivot-based and posterior-stabilised total knee arthroplasty based on anterior translation and clinical scores.MethodsTo assess outcomes of total knee arthroplasty for varus osteoarthritis, the anterior translation distance of the tibia relative to the femur was measured at 30 and 60° of flexion using a KS measure Arthrometer at 6 months postoperatively. The 2011 Knee Society Score, Forgotten Joint Score, visual analogue scale for pain, and range of motion were assessed at 6 months and 1 year postoperatively. The correlations among each score, anterior translation distance, range of motion, and visual analogue scale score for pain were investigated.ResultsThe medial-pivot and posterior-stabilised groups comprised 70 and 51 patients, respectively. The medial-pivot group exhibited a significantly shorter anterior translation distance at 60° flexion than the posterior-stabilised group. Furthermore, the medial-pivot group achieved significantly better outcomes regarding the visual analogue scale for pain, 2011 Knee Society Score, and Forgotten Joint Score than the posterior-stabilised group. A significant negative correlation was observed between the anterior translation distance and the function score of the 2011 Knee Society Score, whereas a significant positive correlation was found between the anterior translation distance and flexion angle, and between the extension angle and score of the Forgotten Joint Score or 2011 Knee Society Score. Significant negative correlations were also found between the pain visual analogue scale and both the 2011 Knee Society Score and Forgotten Joint Score.ConclusionIn total knee arthroplasty for osteoarthritis, the medial-pivot group displayed a shorter anterior translation distance than the posterior-stabilised group at 6 months postoperatively. The visual analogue scale score for pain was also significantly lower in the medial-pivot group than that in the posterior-stabilised group at both 6 months and 1 year postoperatively. Because a correlation was observed between the anterior translation distance and the function score, medial-pivot-based total knee arthroplasty was considered to significantly improve postoperative function compared to posterior-stabilised total knee arthroplasty.

Project description:BACKGROUND:The study of localized immune-related factors has proven beneficial for a variety of conditions, and one area of interest in the field of orthopaedics is the impact of implants and localized infections on immune response. Several cytokines have shown increased systemic concentrations (in serum/plasma) in response to implants and infection, but tissue-level cytokines have not been investigated as thoroughly. METHODS:This exploratory study investigated tissue-level cytokines in a cohort of patients (N?=?17) in response to total knee arthroplasty and total knee revision to better understand the immune response to implants and localized infection (e.g., prosthetic joint infection). The overall goal of this study was to provide insight into the localized cytokine response of tissues and identify tissue-level markers specific to inflammation caused by implants vs. inflammation caused by infection. Tissues were collected across several anatomical locations and assayed with a panel of 20 human inflammatory cytokines to understand spatial differences in cytokine levels. RESULTS:In this study, six cytokines were elevated in implanted joints, as compared to native joints: IL-10, IL-12p70, IL-13, IL-17A, IL-4, and TNF-? (p?<?0.05). Seven cytokines showed infection-dependent increases in localized tissues: IL-1?, IL-1?, IL-6, IL-8, MCP-1, MIP-1?, and MIP-1? (p?<?0.05). CONCLUSIONS:This study demonstrated that differences exist in tissue-level cytokines in response to presence of implant, and some cytokines were specifically elevated for infection; these responses may be informative of overall tissue health. These results highlight the utility of investigating localized cytokine concentrations to offer novel insights for total knee arthroplasty and total knee revision procedures, as well as their complications. Ultimately, this information could provide additional, quantitative measurements of tissue to aid clinical decision making and patient treatment options.

Dataset Information

Placing a price on medical device innovation: the example of total knee arthroplasty.

Background

Methods

Results

Conclusions

Publications

Placing a price on medical device innovation: the example of total knee arthroplasty.

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