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Journal of Long-Term Effects of Medical Implants

年間 4 号発行

ISSN 印刷: 1050-6934

ISSN オンライン: 1940-4379

SJR: 0.184 SNIP: 0.485 CiteScore™:: 1.1 H-Index: 39

Indexed in

Design Considerations in Implant-Related Randomized Trials

巻 17, 発行 2, 2007, pp. 153-163
DOI: 10.1615/JLongTermEffMedImplants.v17.i2.80
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要約

Implant-related research is particularly prone to produce biased results. Despite a common commitment to evidence-based principles (EBM) principles in current literature, a gap remains between the existing available evidence and its actual implementation in orthopaedic clinical practice. Knowledge of basic principles of implant related trial design is a prerequisite for critical appraisal of the value of scientific evidence and thereby the degree of uncertainty. This article discusses how the quality of implant-related randomized controlled trials (RCT) can be affected by the level of expertise, the choice of outcome measures, the allocation procedure, and the method of blinding. Taking these issues into consideration in the design of an implant-related study improves the value of the study, thereby achieving an unbiased assessment of the safety and efficacy of an innovative implant prior to its widespread implementation in daily health care.

によって引用された
  1. Pignataro Gustavo Soriano, Lins Theophilo Ásfora, Oliveira José Renato Assis Lemos Marques de, Moraes Vinícius Ynoe de, Okamura Aldo, Belloti João Carlos, Faloppa Flávio, Estudos prospectivos e não randomizados na ortopedia e traumatologia: avaliação sistemática da qualidade metodológica, Revista Brasileira de Ortopedia, 48, 2, 2013. Crossref

  2. Pignataro Gustavo Soriano, Lins Theophilo Ásfora, Oliveira José Renato Assis Lemos Marques de, Moraes Vinícius Ynoe de, Okamura Aldo, Belloti João Carlos, Faloppa Flávio, Prospective Non-randomized Studies in Orthopaedics and Traumatology: Systematic Assessment of its Methodological Quality, Revista Brasileira de Ortopedia (English Edition), 48, 2, 2013. Crossref

  3. Kashi Ajay, Saha Subrata, Evidence-Based Techniques to Assess the Performance of Dental Implants, Journal of Oral Implantology, 39, 6, 2013. Crossref

  4. Schnell-Inderst Petra, Hunger Theresa, Conrads-Frank Annette, Arvandi Marjan, Siebert Uwe, Recommendations for primary studies evaluating therapeutic medical devices were identified and systematically reported through reviewing existing guidance, Journal of Clinical Epidemiology, 94, 2018. Crossref

  5. Moraes Vinícius Ynoe de, Ferrari Paula Martins de Oliveira, Gracitelli Guilherme Conforto, Faloppa Flávio, Belloti João Carlos, Outcomes in orthopedics and traumatology: translating research into practice, Acta Ortopédica Brasileira, 22, 6, 2014. Crossref

  6. Zazirnyi I.M., Ceramic-on-Ceramic Bearings in Total Joint Arthroplasty. Part 1, Visnyk Ortopedii Travmatologii Protezuvannia, 2(113), 2022. Crossref

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