Systematic review of the introduction, early phase study and evaluation of pyrocarbon proximal interphalangeal joint arthroplasty

Autor: Natalie S Blencowe, Jane M Blazeby, Conor S Jones, Paul Welford, Emily Pardington, Barry Main
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Medical Implants
medicine.medical_treatment
Health Care Providers
Joint Prosthesis
Biocompatible Materials
Cohort Studies
Medicine and Health Sciences
Medicine
Medical Personnel
Medical Device Legislation
Multidisciplinary
Research Assessment
Professions
Systematic review
Research Design
Evaluation Studies as Topic
Inclusion and exclusion criteria
Engineering and Technology
Research Article
Biotechnology
medicine.medical_specialty
Systematic Reviews
Science
Biomaterial Implants
MEDLINE
Bioengineering
Surgical and Invasive Medical Procedures
Research and Analysis Methods
Arthroplasty
Musculoskeletal System Procedures
Physicians
Humans
Surgeons
Research ethics
business.industry
Clinical study design
Patient Selection
Biology and Life Sciences
Retrospective cohort study
Carbon
Health Care
People and Places
Physical therapy
Medical Devices and Equipment
Population Groupings
business
Interphalangeal Joint
Zdroj: PLoS ONE
PLoS ONE, Vol 16, Iss 10, p e0257497 (2021)
Welford, P, Blencowe, N S, Pardington, E, Jones, C S, Blazeby, J & Main, B 2021, ' Systematic review of the introduction, early phase study and evaluation of pyrocarbon proximal interphalangeal joint arthroplasty ', PLoS ONE . https://doi.org/10.1371/journal.pone.0257497
ISSN: 1932-6203
DOI: 10.1371/journal.pone.0257497
Popis: Background In 2002 a pyrocarbon interphalangeal joint implant was granted Food and Drug Administration approval with limited evidence of effectiveness. It is important to understand device use and outcomes since this implant entered clinical practice in order to establish incremental evidence, appropriate study design and reporting. This systematic review summarised and appraised studies reporting pyrocarbon proximal interphalangeal joint arthroplasty. Methods Systematic review of MEDLINE, EMBASE, SCOPUS, Web of Science, BIOSIS, CINAHL and CENTRAL from inception to November 2020. All study designs reporting pyrocarbon proximal interphalangeal joint arthroplasty in humans were included. Data extracted included information about study characteristics, patient selection, regulatory (gaining research ethics approval) and governance issues (reporting of conflicting interests), operator and centre experience, technique description and outcome reporting. Descriptive and narrative summaries were reported. Results From 4316 abstracts, 210 full-text articles were screened. A total of 38 studies and 1434 (1–184) patients were included. These consisted of three case reports, 24 case series, 10 retrospective cohort studies and one randomised trial. Inclusion and exclusion criteria were stated in 25 (66%) studies. Most studies (n = 27, 71%) gained research ethics approval to be conducted. Six studies reported conflicting interests. Experience of operating surgeons was reported in nine (24%) and caseload volume in five studies. There was no consensus about the optimal surgical approach. Technical aspects of implant placement were reported frequently (n = 32) but the detail provided varied widely. Studies reported multiple, heterogenous outcomes. The most commonly reported outcome was range of motion (n = 37). Conclusions This systematic review identified inconsistencies in how studies describing the early use and update of an innovative procedure were reported. Incremental evidence was lacking, risking the implant being adopted without robust evaluation. This review adds to evidence highlighting the need for more rigorous evaluation of how implantable medical devices are used in practice following licencing.
Databáze: OpenAIRE
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