Appraisal of evidence base for introduction of new implants in hip and knee replacement: a systematic review of five widely used device technologies

Nieuwenhuijse, Marc J; Nelissen, Rob G H H; Schoones, Jan W.; Sedrakyan, Art

doi:10.1136/bmj.g5133

Cited by 77 publications

(50 citation statements)

References 39 publications

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“…This is particularly true given that new models of devices are rapidly incorporated in clinical practice [11]. Several studies have shown poor performance of various newly released orthopaedic devices without supporting premarket clinical data [7,14,16]. In addition, remarketing of new devices based on changes implemented via PMA supplements may permit devices that may be used for substantially different purposes than supported by original clinical evidence [34].…”

Section: Device Recalls and Market Withdrawalmentioning

confidence: 99%

“…The field of orthopaedic surgery relies heavily on implants, which can have a high-cost of failure to the patient [18]. In the past, high-risk orthopaedic devices cleared through the 510(k) pathway have been shown to lack adequate evidence supporting safety and effectiveness [16], and therefore undergo recalls [1]. Although orthopaedic devices cleared via the 510(k) pathway have been studied [1,7,22], numerous commonly used, high-risk orthopaedic devices currently require PMA approval and may undergo postmarket changes via PMA supplements, including alternative bearing THA systems, hip resurfacing systems, and mobile bearing total knee systems.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?

Samuel

Rathi

Grauer

et al. 2016

Clinical Orthopaedics &Amp; Related Research

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Background The FDA approves novel, high-risk medical devices through the premarket approval (PMA) process based on clinical evidence supporting device safety and effectiveness. Devices subsequently may undergo postmarket modifications that are approved via one of several PMA supplement review tracks, usually without additional supporting clinical data. While orthopaedic devices cleared via the less rigorous 510(k) pathway have been studied previously, devices cleared through the PMA pathway and those receiving postmarket PMA supplements warrant further investigation. Questions/purposes We asked: What are (1) the types of original orthopaedic devices receiving FDA PMA approval, (2) the number and rate of postmarket device changes approved per device, (3) the types of PMA supplement review tracks used, (4) the types of device changes approved via the various review tracks, and (5) the number of device recalls and market withdrawals that have occurred for these devices? Methods All original PMA-approved orthopaedic devices between January 1982 and December 2014 were identified in the publically available FDA PMA database. The number of postmarket device changes approved, the PMA supplement review track used, the types of postmarket changes, and any FDA recalls for each device were assessed. Results Seventy original orthopaedic devices were approved via the FDA PMA pathway between 1982 and

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Section: Device Recalls and Market Withdrawalmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?

Samuel

Rathi

Grauer

et al. 2016

Clinical Orthopaedics &Amp; Related Research

View full text Add to dashboard Cite

show abstract

“…To our knowledge, there is no similar metal-free system available on the market. As total hip and total knee replacement systems made of ceramic are currently being developed and optimized, [12,13] future efforts concerning metal-free intramedullary systems for interphalangeal arthrodesis might be necessary.…”

Section: Discussionmentioning

confidence: 99%

Interphalangeal arthrodesis using an intramedullary nitinol implant: a prospective study

Jakubek

Enzendorfer

Fiala

et al. 2017

Eklem Hastalik Cerrahisi

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“…Some recent papers showed little improvement in outcome during the last decade with new implants. 7,8 However, the specific questions asked and the periods of time which were studied in such papers affect the results. Innovation tends to occur in a stepwise rather than linear manner, and studying a short time interval may fail to capture a stepwise improvement in outcome.…”

Section: Observationmentioning

confidence: 99%

Joint registries

Berry

2017

The Bone & Joint Journal

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AimsTo demonstrate, with concrete examples, the value of in-depth exploration and comparison of data published in National Joint Arthroplasty registry reports. Patients and MethodsThe author reviewed published current reports of National Joint Arthroplasty registries for findings of current significance to current orthopaedic practice. ResultsA total of six observations that demonstrate actionable or unexpected findings from joint registries are described. These include: one third to one half of all arthroplasty failures in the first decade occur in the first one to two years; infection rates after arthroplasty have not declined in the last three decades; infection after TKA is more common in men than women; outcomes of TKA are more variable in young compared with older patients; new technologies (uncemented implants and crosslinked polyethylene) have improved results of THA and a real-time shift in use of ceramic femoral heads is occurring in THA. ConclusionThese six observations may be used to better understand current practice, stimulate practice improvements or suggest topics for further study.

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Appraisal of evidence base for introduction of new implants in hip and knee replacement: a systematic review of five widely used device technologies

Abstract: Objective To determine the evidence of effectiveness and safety for introduction of five recent and ostensibly high value implantable devices in major joint replacement to illustrate the need for change and inform guidance on evidence based introduction of new implants into healthcare.

Cited by 77 publications

References 39 publications

How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?

How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?

Interphalangeal arthrodesis using an intramedullary nitinol implant: a prospective study

Joint registries

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