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Published in: Clinical Orthopaedics and Related Research® 7/2014

01-07-2014 | Editorial

Editorial: When “Safe and Effective” Becomes Dangerous

Author: Seth S. Leopold, MD

Published in: Clinical Orthopaedics and Related Research® | Issue 7/2014

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Excerpt

Commercials might claim a product is “safe and effective,” but most research studies should not. Small, focused studies may deem one treatment more effective than another, but the problem arises when authors of such studies claim safety based on the observation that few (or no) patients were hurt by some intervention. Such claims may be misleading. …
Literature
1.
go back to reference Huang DC, Tatman P, Mehle S, Gioe TJ. Cumulative revision rate is higher in metal-on-metal THA than metal-on-polyethylene THA: Analysis of survival in a community registry. Clin Orthop Relat Res. 2013;471:1920–1925.PubMedCentralPubMedCrossRef Huang DC, Tatman P, Mehle S, Gioe TJ. Cumulative revision rate is higher in metal-on-metal THA than metal-on-polyethylene THA: Analysis of survival in a community registry. Clin Orthop Relat Res. 2013;471:1920–1925.PubMedCentralPubMedCrossRef
2.
go back to reference Jüni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M. Risk of Cardiovascular events and Rofecoxib: Cumulative meta-analysis. Lancet. 2004;364:2021–2029.PubMedCrossRef Jüni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M. Risk of Cardiovascular events and Rofecoxib: Cumulative meta-analysis. Lancet. 2004;364:2021–2029.PubMedCrossRef
3.
go back to reference Lee DH, Ryu KJ, Song HR, Han SH. Complications of the intramedullary skeletal kinetic distractor (ISKD) in distraction osteogenesis. [Published online ahead of print March 7, 2014]. Clin Orthop Relat Res. DOI: 10.1007/s11999-014-3547-4. Lee DH, Ryu KJ, Song HR, Han SH. Complications of the intramedullary skeletal kinetic distractor (ISKD) in distraction osteogenesis. [Published online ahead of print March 7, 2014]. Clin Orthop Relat Res. DOI: 10.​1007/​s11999-014-3547-4.
4.
go back to reference Lee KJ, Min BW, Bae KC, Cho CH, Kwon DH. Efficacy of multimodal pain control protocol in the setting of total hip arthroplasty. Clinics in Orthopedic Surgery. 2009;1:155–160.PubMedCentralPubMedCrossRef Lee KJ, Min BW, Bae KC, Cho CH, Kwon DH. Efficacy of multimodal pain control protocol in the setting of total hip arthroplasty. Clinics in Orthopedic Surgery. 2009;1:155–160.PubMedCentralPubMedCrossRef
6.
go back to reference Prentice JR, Clark MJ, Hoggard N, Morton AC, Tooth C, Paley MN, Stockley I, Hadjivassiliou M, Wilkinson JM. Metal-on-metal hip prostheses and systemic health: A cross-sectional study 8 years after implantation. PLoS One. 2013;8:e66186.PubMedCentralPubMedCrossRef Prentice JR, Clark MJ, Hoggard N, Morton AC, Tooth C, Paley MN, Stockley I, Hadjivassiliou M, Wilkinson JM. Metal-on-metal hip prostheses and systemic health: A cross-sectional study 8 years after implantation. PLoS One. 2013;8:e66186.PubMedCentralPubMedCrossRef
7.
go back to reference Reito A, Puolakka T, Elo P, Pajamäki J, Eskelinen A. High prevalence of adverse reactions to metal debris in small-headed ASR™ hips. Clin Orthop Relat Res. 2013;471:2954–2961.PubMedCrossRef Reito A, Puolakka T, Elo P, Pajamäki J, Eskelinen A. High prevalence of adverse reactions to metal debris in small-headed ASR™ hips. Clin Orthop Relat Res. 2013;471:2954–2961.PubMedCrossRef
10.
go back to reference Urban RM, Jacobs JJ, Tomlinson MJ, Gavrilovic J, Black J, Peoc’h M. Dissemination of wear particles to the liver, spleen, and abdominal lymph nodes of patients with hip or knee replacement. J Bone Joint Surg. 2000;82-A:457–476. Urban RM, Jacobs JJ, Tomlinson MJ, Gavrilovic J, Black J, Peoc’h M. Dissemination of wear particles to the liver, spleen, and abdominal lymph nodes of patients with hip or knee replacement. J Bone Joint Surg. 2000;82-A:457–476.
11.
go back to reference Vendittoli PA, Makinen P, Drolet P, Lavigne M, Fallaha M, Guertin MC, Varin F. A multimodal analgesia protocol for total knee arthroplasty: A randomized, controlled study. J Bone Joint Surg. 2006;88-A:282–289. Vendittoli PA, Makinen P, Drolet P, Lavigne M, Fallaha M, Guertin MC, Varin F. A multimodal analgesia protocol for total knee arthroplasty: A randomized, controlled study. J Bone Joint Surg. 2006;88-A:282–289.
12.
go back to reference Ward WG Sr, Carter CJ, Wilson SC, Emory CL. Femoral stress fractures associated with long-term bisphosphanate treatment. Clin Orthop Relat Res. 2012;470:759–765.PubMedCentralPubMedCrossRef Ward WG Sr, Carter CJ, Wilson SC, Emory CL. Femoral stress fractures associated with long-term bisphosphanate treatment. Clin Orthop Relat Res. 2012;470:759–765.PubMedCentralPubMedCrossRef
Metadata
Title
Editorial: When “Safe and Effective” Becomes Dangerous
Author
Seth S. Leopold, MD
Publication date
01-07-2014
Publisher
Springer US
Published in
Clinical Orthopaedics and Related Research® / Issue 7/2014
Print ISSN: 0009-921X
Electronic ISSN: 1528-1132
DOI
https://doi.org/10.1007/s11999-014-3675-x

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