Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature
Purpose: The objective of this systematic review was to give an overview of clinical investigations regarding hip and knee arthroplasty implants published in peer-reviewed scientific medical journals before entry into force of the EU Medical Device Regulation in May 2021. Methods: We systematicall...
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| Format: | Article |
| Language: | English |
| Published: |
Bioscientifica
2023-11-01
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| Series: | EFORT Open Reviews |
| Subjects: | |
| Online Access: | https://eor.bioscientifica.com/view/journals/eor/8/11/EOR-23-0024.xml |
| _version_ | 1797641610704453632 |
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| author | Anne Lübbeke Christophe Combescure Christophe Barea Amanda Inez Gonzalez Keith Tucker Per Kjærsgaard-Andersen Tom Melvin Alan G Fraser Rob Nelissen James A Smith |
| author_facet | Anne Lübbeke Christophe Combescure Christophe Barea Amanda Inez Gonzalez Keith Tucker Per Kjærsgaard-Andersen Tom Melvin Alan G Fraser Rob Nelissen James A Smith |
| author_sort | Anne Lübbeke |
| collection | DOAJ |
| description | Purpose: The objective of this systematic review was to give an overview of clinical investigations regarding hip and knee arthroplasty implants published in peer-reviewed scientific medical journals before entry into force of the EU Medical Device Regulation in May 2021.
Methods: We systematically reviewed the medical literature for a random selection of hip and knee implants to identify all peer-reviewed clinical investigations published within 10 years before and up to 20 years after regulatory approval. We report study characteristics, methodologies, outcomes, measures to prevent bias, and timing of clinical investigations of 30 current implants. The review process was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
Results: We identified 2912 publications and finally included 151 papers published between 1995 and 2021 (63 on hip stems, 34 on hip cups, and 54 on knee systems). We identified no clinical studies published before Conformité Européene (CE)-marking for any selected device, and no studies even up to 20 years after CE-marking in one-quarter of devices. There were very few randomized controlled trials, and registry-based studies generally had larger sample sizes and better methodology.
Conclusion: The peer-reviewed literature alone is insufficient as a source of clinical investigations of these high-risk devices intended for life-long use. A more systematic, efficient, and faster way to evaluate safety and performance is necessary. Using a phased introduction approach, nesting comparative studies of observational and experimental design in existing registries, increasing the use of benefit measures, and accelerating surrogate outcomes research will help to minimize risks and maximize benefits. |
| first_indexed | 2024-03-11T13:48:09Z |
| format | Article |
| id | doaj.art-5854436f742e41218a5082ecb9e6d204 |
| institution | Directory Open Access Journal |
| issn | 2058-5241 |
| language | English |
| last_indexed | 2024-03-11T13:48:09Z |
| publishDate | 2023-11-01 |
| publisher | Bioscientifica |
| record_format | Article |
| series | EFORT Open Reviews |
| spelling | doaj.art-5854436f742e41218a5082ecb9e6d2042023-11-02T09:44:39ZengBioscientificaEFORT Open Reviews2058-52412023-11-01811781791https://doi.org/10.1530/EOR-23-0024Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literatureAnne Lübbeke0Christophe Combescure1Christophe Barea2Amanda Inez Gonzalez3Keith Tucker4Per Kjærsgaard-Andersen5Tom Melvin6Alan G Fraser7Rob Nelissen8James A Smith9Division of Orthopaedic Surgery & Traumatology, Geneva University Hospitals and University of Geneva, Switzerland; Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK Division of Clinical Epidemiology, Geneva University Hospitals and University of Geneva, SwitzerlandDivision of Orthopaedic Surgery & Traumatology, Geneva University Hospitals and University of Geneva, SwitzerlandDivision of Orthopaedic Surgery & Traumatology, Geneva University Hospitals and University of Geneva, SwitzerlandChair Orthopaedic Data Evaluation Panel, UKCenter for Adult Hip and Knee Reconstruction, Department of Orthopaedics, South Danish University, Vejle Hospital, DenmarkSchool of Medicine, Trinity College Dublin, IrelandDepartment of Cardiology, University Hospital of Wales, Cardiff, UKDepartment of Orthopaedics, Leiden University Medical Center, Leiden, The NetherlandsCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK; National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, UK Purpose: The objective of this systematic review was to give an overview of clinical investigations regarding hip and knee arthroplasty implants published in peer-reviewed scientific medical journals before entry into force of the EU Medical Device Regulation in May 2021. Methods: We systematically reviewed the medical literature for a random selection of hip and knee implants to identify all peer-reviewed clinical investigations published within 10 years before and up to 20 years after regulatory approval. We report study characteristics, methodologies, outcomes, measures to prevent bias, and timing of clinical investigations of 30 current implants. The review process was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results: We identified 2912 publications and finally included 151 papers published between 1995 and 2021 (63 on hip stems, 34 on hip cups, and 54 on knee systems). We identified no clinical studies published before Conformité Européene (CE)-marking for any selected device, and no studies even up to 20 years after CE-marking in one-quarter of devices. There were very few randomized controlled trials, and registry-based studies generally had larger sample sizes and better methodology. Conclusion: The peer-reviewed literature alone is insufficient as a source of clinical investigations of these high-risk devices intended for life-long use. A more systematic, efficient, and faster way to evaluate safety and performance is necessary. Using a phased introduction approach, nesting comparative studies of observational and experimental design in existing registries, increasing the use of benefit measures, and accelerating surrogate outcomes research will help to minimize risks and maximize benefits. https://eor.bioscientifica.com/view/journals/eor/8/11/EOR-23-0024.xmlsystematic reviewhip arthroplastyknee arthroplastyclinical evidenceregistriesmedical device regulation |
| spellingShingle | Anne Lübbeke Christophe Combescure Christophe Barea Amanda Inez Gonzalez Keith Tucker Per Kjærsgaard-Andersen Tom Melvin Alan G Fraser Rob Nelissen James A Smith Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature EFORT Open Reviews systematic review hip arthroplasty knee arthroplasty clinical evidence registries medical device regulation |
| title | Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature |
| title_full | Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature |
| title_fullStr | Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature |
| title_full_unstemmed | Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature |
| title_short | Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature |
| title_sort | clinical investigations to evaluate high risk orthopaedic devices a systematic review of the peer reviewed medical literature |
| topic | systematic review hip arthroplasty knee arthroplasty clinical evidence registries medical device regulation |
| url | https://eor.bioscientifica.com/view/journals/eor/8/11/EOR-23-0024.xml |
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