Due to the fact that its sterility cannot be assured, custom cranial implant kits manufactured by Stryker have been recalled. The kits are intended to be used to correct trauma or defects in the upper and lower jaw, face, or craniofacial bone. Stryker’s sales reps, as well as doctors, were notified of the Class I recall at the end of October via a letter that instructed them to check for infections by following up with patients for up to six months after surgery.Â
To sort out the therapeutic wheat from the chaff, earlier this month the Academy of Orthopedic Surgeons (AAOS) approved and released a clinical practice guideline on “Treatment of Osteoarthritis of the Knee.†Developed by an AAOS physician volunteer work group, the guideline was based upon a systematic review of current scientific and clinical information on accepted approaches to the treatment and diagnosis of osteoarthritis of the knee in adults. According to the authors, the evidence-based guideline was explicitly developed to include only treatments that are less invasive than knee replacement surgery.
Among the prereplacement treatments evaluated for the guideline, few device-related therapies made the list of recommendations. For instance, the guideline recommends that surgeons do not perform an arthroscopic lavage if a patient displays only symptoms of osteoarthritis and there is no suggestion of other problems, such as loose bodies or meniscus tears. But if mechanical problems such as loose bodies or meniscal tears are present, then arthroscopy can be potentially beneficial. “The current science shows us that just washing out the joint does not decrease the patient’s osteoarthritis symptoms and can expose the patient to additional risk,†said John Richmond, MD, chair of the AAOS work group.
Manufacturers will find the guidance a useful resource for understanding physician needs in relation to prereplacement therapies, as well as the status of patients who are approaching the need for replacement therapy.
