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How Should New Implants be Monitored

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The public expects 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 the implant itself (ie, free from design and production flaws) and the method for which it is used (ie, 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 (ie, 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understand how implants with a high complication rate make their way into general practice without being identified and withdrawn from the market. They are especially dismayed when the essentially self-policing medical profession fails to act promptly in the face of obvious evidence that an implant or technique is faulty or inferior to established standards.

These errors often result in large class action lawsuits. Examples relevant to orthopaedics include the following:

  • Intra-articular pain pumps, causing chondrolysis
  • The ASR hip, with high failure rates
  • Long-term bisphosphonate use, leading to atypical femoral fractures

A recent article by Wiater et al, which was generated by a court-ordered review of medical records, revealed a disturbing number of patients who developed shoulder chondrolysis, a devastating complication in a young individual, in the practice of one community orthopaedic surgeon following the introduction of intra-articular pain pumps that infused highly acidic local anaesthetics into the joint post-surgery.1 This was a complication that was, quite simply, rarely, if ever, seen before. The plaintiffs in this class action suit cannot be blamed for asking why no one noticed this severe complication following introduction of the new technology, and, how 6 years after the first identified case in this study, 26 patients developed chondrolysis in one surgeon’s practice with the use of this device.

Room for Improvement

While it is reasonable to state that the majority of new implants and techniques that we introduce in orthopaedics are beneficial to our patients and do not become subject to medico-legal scrutiny, the examples described above clearly demonstrate that there is room for improvement. It is essential that this improvement develops from within, and that the stakeholders with the most to gain or lose, such as individual surgeons, organized groups (like the Canadian Orthopaedic Association), and industry should share in this process improvement. No single entity will be sufficient to effect change.

The use of joint registries that can detect early, subtle differences in implant survival are to be encouraged and expanded to include other areas, such as shoulder, elbow, and ankle arthroplasties. Randomized and prospective trials, comparing new implants/techniques to established ones and monitored by conflict-free panels, should be funded and promoted at every level. An industry that focuses on ethical promotion of new products and is sensitive and transparent in the reporting of novel complications (an unfortunate accompaniment of new technology, good or bad) is critical.

It is clear that the individual surgeon, with the exception of the occasional perceptive “whistle-blower,” is not in a good position to see the overall picture. However, we owe it to our patients to be more circumspect before we wholeheartedly embrace new technology. Hopefully, the focus on evidence-based medicine now seen in medical schools and orthopaedic training programs will encourage the practicing orthopaedic surgeons to think more critically, and not to be “faddist.”

As a group, we need to recognize that we are in the best position to advocate for effective change that does not dampen the quest for improvement, lest undesirable change be forced or legislated upon us.


Figure 1. Locked intramedullary nails were vigorously promoted as a superior treatment for humeral shaft fractures until prospective trials revealed higher reoperation and complication rates with their use when compared to conventional plating.2

Key Points

  1. There is room for improvement in the monitoring of new orthopaedic implants.
  2. Of particular importance is the rapid recognition of novel complications associated with new implants.
  3. The solution lies with industry - surgeon - professional group cooperation

References

  1. Wiater B.P., Neradilek M.B., Polissar N.L., Matsen F.A. Risk factors for chondrolysis of the glenohumeral joint: a study of three hundred and seventy-five shoulder arthroscopic procedures in the practice of an individual community surgeon. J Bone Joint Surg Am. 2011;93: 615-25
  2. Bhandari M., Devereaux P.J., McKee M.D., Schemitsch E.H. Compression plating versus intramedullary nailing of humeral shaft fractures--a meta-analysis. Acta Orthop. 2006 Apr;77(2):279-84. Review.

Reprinted with permission from the Fall 2011 issue of COA Bulletin