News on Wellness

Newer Joint Pain Devices May Not be Beneficial

Joint PainThere have been numerous improvements in joint replacement devices but now according to a newly published article in the BMJ, they may present more risk than benefit. Authors of the publication state there is no evidence in existence whereby recommendation can be made for five of the newer joint pain devices designs over those already established. In fact, some of the newer devices pose increased risk of revision surgery.

Dr. Marc J. Nieuwenhuijse is a reputable expert who currently works with the Patient Centered Comparative Effectiveness Program, United States Food and Drug Administration (FDA) Medical Device Epidemiology Science and Infrastructure Center, New York Department of Public Health, Weill Cornell Medical College, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Department of Orthopaedics, and Leiden University Medical Center.

Dr. Nieuwenhuijse along with his colleagues believes that new technologies are introduced for consumer use and purchase without there being high quality evidence of improved benefit over existing and safe alternative implant options. He adds that the status quo specific to the introduction of new device technologies is simply unacceptable.

In a systematic review, Dr. Nieuwenhuijse and his colleagues looked at five devices promoted as being an improvement over earlier technology. These included modular femoral necks, ceramic-on-ceramic bearings, high-flexion implants, uncemented monoblock acetabular cups for total hip replacements, and sex specific total knee replacement implants.

Three criteria were used to determine effectiveness and safety of the five new devices to include having a rationale for expected superior outcome, achieving a minimum of 90% completeness in a national orthopedic registry, and being comparable to a traditional device for the same use.

Devices Excluded from Review

While several of the newer joint devices were reviewed, some were excluded to include the following:

• Metal-on-metal hip replacements since in 2013, the FDA provided cautionary guidelines advising of potential release of metal debris but also, more prevalent revision surgery

• Unicompartmental knee arthroplasty

• Resurfacing total hip replacements

• Highly cross-linked polyethylene hip replacements due to unavailability of long-term follow up data

Raising Concerns

As part of the review, 118 studies were identified, which involved 13,164 patients with 15,384 implants. Dr. Nieuwenhuijse and his colleagues were unable to identify any clinically relevant evidence of improvement in four of the five devices. In the fifth device, modular femoral necks, evidence was insufficient.

Overall, issues with revision rates, new device versus existing device complications, and lack of supportive research were identified. Based on the findings, Dr. Nieuwenhuijse recommends that new features should only be used in a very small number of patients prior to being approved for much broader use. He goes on to say that manufacturers need to demonstrate that new joint devices are substantially equivalent to designs with previous approval.

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