Orthopaedic Articles - Articles for Orthopaedic Practice

Orthopaedic articles on current trends, tips & tricks and best evidence from top orthopaedic specialists.

How Should New Implants be Monitored in Canada?

Michael D. McKee


How Should New Implants be Monitored in Canada?

Michael D. McKee, M.D., FRCSC
Professor of Orthopaedic Surgery, Division of Orthopaedic Surgery,
Department of Surgery, St. Michael's Hospital and the University of Toronto,
Toronto, ON

The Canadian public expects, with reason, that the implants orthopaedic surgeons routinely use in clinical practice are safe, reliable, and proven to be effective. They anticipate that this will hold true for both the implant itself (i.e. free from design and production flaws), and the method for which it is used (i.e. intra-articular "pain pumps" for postoperative analgesia). To a certain extent, the public, exposed to endless stories in the popular press regarding the success of the latest medical interventions (i.e. hand and face transplantation), cannot understand how implants with a high complication rate make their way into general practice without being identified and withdrawn from the market.




The Case of Metal-on-Metal Implant Recalls - What Have We Learned?

John Antoniou


The Case of Metal-on-Metal Implant Recalls - What Have We Learned?

Gregory Manoudis M.D.
John Antoniou M.D., PhD, FRCSC
Montreal, QC

In recent decades, the introduction of new drugs and implants has often been accompanied by enthusiastic acceptance by the medical community. However there are cases where this initial enthusiasm is dampened by unexpected complications.



Post-market Monitoring of New Implants: Are Registries the Answer?

Robert B. Bourne


Post-market Monitoring of New Implants: Are Registries the Answer?

Robert B. Bourne, M.D., FRCSC
University Hospital
University of Western Ontario
London, ON

"When patients' best interests are looked after, everything else falls into place."

When ill, Canadians want the latest medical treatments including drugs, medical devices and new technologies, yet want to be assured that these treatments are safe, efficacious and in the case of medical devices, durable. Preclinical testing, randomized clinical trials and multicentre studies all help in assuring safety and efficacy, yet there remains a need for post-market surveillance to assure the public that a new treatment is durable and not associated with unexpected consequences1.




Is “IDEAL” Enough? Proposal for a New Framework (METEOR)

Mohit Bhandari


Is "IDEAL" Enough? Proposal for a New Framework (METEOR)

Dirk Stengel, M.D., PhD, MSc
Kathleen Füssler, MSc
Centre for Clinical Research,
Department of Trauma and Orthopaedic Surgery
Unfallkrankenhaus Berlin, Germany

Mohit Bhandari, M.D., MSc, FRCSC
Department of Surgery and Department of Clinical Epidemiology & Biostatistics, McMaster University
Hamilton, ON

Many surgical research projects commence with ideas, technical modifications and individual observations rather than specific hypotheses. The methodological difficulties of evaluating surgical complexity by established clinical research designs have been realized for years, but remain a matter of controversy and debate. In a series of three papers, the Balliol Group highlighted current shortcomings and summarized the archetype of surgical clinical research in the IDEAL statement (Idea, Development, Exploration, Assessment, Long-term Surveillance)1-3. While IDEAL gives a detailed overview of the past and reflects the present, it neither offers forward-looking solutions nor addresses the specific issues of orthopaedic surgery.







The Cycle of Innovation: The IDEAL Framework

Mohit Bhandari


The Cycle of Innovation: The IDEAL Framework

Mohit Bhandari, M.D., MSc, FRCSC
Department of Surgery and Department of Clinical Epidemiology & Biostatistics, McMaster University
Hamilton, ON

Orthopaedic surgery is a highly innovative specialty. The rapidity of innovation often outpaces the opportunity to conduct scientifically rigorous studies to ensure patient safety and efficacy. The cycle of innovation, in its current state, often results in the removal of one in four new devices from the market within five years, and about three of four devices within ten years1.



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