Journal of long-term effects of medical implants
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J Long Term Eff Med Implants · Jan 2007
What is involved in a regulatory trial investigating a new medical device?
Regulatory trials allow for the clinical evaluation of new drugs and medical devices, determining whether or not they can be safely and effectively used in patient care. The outcome of these trials may result in new and better ways of preventing, diagnosing, and treating illness. However, conducting a regulatory trial to evaluate a new medical device is a complex and time-intensive process involving many parties. This paper will provide an overview of the regulatory approval process for medical devices in the United States and will discuss what is involved in conducting a regulatory trial investigating a new device.
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J Long Term Eff Med Implants · Jan 2006
Biography Historical ArticleA tribute to Dr. Robert C. Allen, an inspirational teacher, humanitarian, and friend (Nov. 18, 1950-Mar. 24, 2005).
Dr. Robert C. Allen was a gifted educator, as well as experienced ophthalmologist, who was a close personal friend of Dr. ⋯ For the contact lens, you should go to the website for more information http://www.nike.com/nikevision/content.html. The website has a list of practitioners who can service the patients with the respective sunglasses. With their exciting technologic advances in sunglass products, as well as tinted soft contact lens, the authors would encourage Nike Vision to develop an expanded international marketing program that allows all individuals in the world to easily purchase its products.
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J Long Term Eff Med Implants · Jan 2006
ReviewLong-term effects of vertebroplasty: adjacent vertebral fractures.
In today's aging population, osteoporosis-related fractures are an ever-growing concern. Vertebroplasty, a promising yet cost-effective treatment for vertebral compression fractures, has an increasing role. The first vertebroplasty procedures were reported by Deramond and Galibert in France in 1987, and international interest grew with continued development of clinical techniques and augmentation materials in Europe and the United States. ⋯ The pillar effect of injected cement is hypothesized to decrease the endplate bulge in the augmented vertebra causing an increase in adjacent disc pressure that is communicated to the adjacent vertebra. To confirm the viability of the pillar effect as the responsible mechanism, endplate bulge and disc pressure should be directly measured before and after augmentation. Future studies should be concerned with quantifying the current and ideal mechanical response of the spine and subsequently developing cements that can achieve this optimum response.
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Trigeminal neuralgia (TN) is the most common facial neuralgia, and is considered to be one of the most painful conditions to affect patients. The rate of occurrence of TN in men and women is 2.5 and 5.7 per 100,000 per year respectively. TN is generally characterized by lancinating, unilateral, paroxysmal pain occurring in the distribution of the fifth cranial nerve. ⋯ Open surgical procedures used in the treatment of TN include microvascular decompression of the trigeminal root and retrogasserian rhizotomy. Additionally, because both of these procedures have greater associated risks, morbidity, and mortality, they are customarily applied only to younger patients in good health. Stereotactic radiosurgery has been established as an alternative treatment for patients who do not respond to optimal medical management.
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J Long Term Eff Med Implants · Jan 2006
ReviewSurface finish mechanics explain different clinical survivorship of cemented femoral stems for total hip arthroplasty.
The ability of bone cement to adhere to the implant surface is dependent on the surface finish. Stems with a rough surface finish require greater force to disrupt their interface with the cement than do stems with a smooth or polished surface. ⋯ This article presents the micro and macro surface finish mechanics, history, and rationale for changes in surface finish, the clinical and operative implications of changes in surface finish, the retrieval analysis, and the clinical evidence that examine the consequences of changes in surface finish in the outcome of cemented femoral stems for total hip arthroplasty. Current data and our own experience support the use of cemented femoral stems with a smooth or polished surface finish.