PubMed · 12198437
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Daniel P Bortnick, PSEF DATA Committee. 2002-09-15. Comments regarding NLite.. https://doi.org/10.1097/01.prs.0000020999.91743.2a
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STUDY DESIGN: A literature review of experiences with vertebroplasty and kyphoplasty for treating symptomatic, osteoporotic vertebral compression fractures (VCFs). OBJECTIVES: To summarize the advantages and disadvantages of kyphoplasty and vertebroplasty. SUMMARY OF BACKGROUND DATA: Osteoporotic VCFs are a leading cause of disability and morbidity in the elderly. The consequences of osteoporotic VCFs (pain and often progressive vertebral collapse with resultant spinal kyphosis) adversely affect quality of life, physical function, mental health, and survival. Vertebroplasty and kyphoplasty are minimally invasive procedures for treating painful fractures. Vertebroplasty entails the percutaneous injection of bone cement into the fractured vertebra in attempts to stabilize the fracture and reduce pain. Kyphoplasty addresses pain and kyphotic deformity by the percutaneous expansion of an inflatable bone tamp to effect fracture reduction before cement deposition in a fractured vertebra. METHODS: A literature review of surgical techniques, indications, clinical results, and complications for vertebroplasty and kyphoplasty. RESULTS: Studies of vertebroplasty and kyphoplasty have reported excellent pain relief and improved function in most patients with osteoporotic VCFs. Vertebroplasty has the advantage of being relatively quick and inexpensive. Kyphoplasty, while associated with increased cost and surgical time, offers the potential to improve spinal alignment. In addition, by creating an intravertebral cavity, kyphoplasty reduces the risk of extravertebral bone filler extravasation. CONCLUSIONS: Vertebroplasty and kyphoplasty are currently used to treat osteoporotic VCFs with successful short-term results. Prospective, randomized studies comparing these procedures to one another and comparing their long-term outcomes to conventional medical management are required to define precise roles of these exciting treatments in the spine physician's armamentarium.
Emerging techniques and technologies in treating spinal disorders appear to be very promising. Vertebroplasty and kyphoplasty are new techniques that have been developed for treating osteoporotic vertebral compression fractures with early promising clinical results. More sophisticated and technically advanced methods of surgical navigation are also being developed as spinal surgery moves toward less invasive or minimally invasive procedures. Cost effectiveness, complication rates, and clinical efficacy need to be better defined to determine the exact role of these emerging techniques and technologies.
The Food and Drug Administration (FDA) is classifying the resorbable calcium salt bone void filler device intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls guidance entitled "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA." This action is being undertaken based on new information submitted in a classification proposal from Wright Medical Technology under the Federal Food, Drug, and Cosmetic Act as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997.