Percutaneous Sacroplasty
DESCRIPTION
Percutaneous sacroplasty involves the injection of radiopaque bone cement, usually polymethyl methacrylate (PMMA), into sacral insufficiency fractures (SIFs) for stabilization. This procedure is proposed to provide an analgesic effect through mechanical stabilization of a fractured or weakened vertebral body. Sacroplasty requires fluoroscopic or ultrasound guidance. Complications include the bone cement migrating out of place (called extravasation) leading to transient radicular pain, neurologic symptoms, pulmonary embolism, deep vein thrombosis, and/or pneumonia.
Sacral insufficiency fractures (SIFs) are the consequence of stress on weakened bone and often cause low back pain in the elderly population. Osteoporosis is the most common risk factor for SIF. Spontaneous fracture of the sacrum in individuals with osteoporosis presents as lower back and buttock pain with or without referred pain in the legs. Although common, SIFs can escape detection due to low provider suspicion and poor sensitivity on plain radiographs, slowing the application of appropriate intervention. Medical interventions include bedrest, bracing, and analgesics. Initial clinical improvements may occur quickly; however, resolution of all symptoms may not occur for 9 to 12 months.
POLICY
Percutaneous sacroplasty for all indications is considered investigational.
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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ADDITIONAL INFORMATION
There is a lack of randomized controlled trials on percutaneous sacroplasty for sacral insufficiency. The small numbers of treated individuals leave uncertainty regarding the impact of sacroplasty on health outcomes.
The use of polymethyl methacrylate (PMMA) in sacroplasty is an off-label use of an FDA-regulated product (bone cements such as Spine-Fix® Biomimetic Bone Cement [Teknimed] and Osteopal® V [Heraeus]) because the 510(k) approval was for the fixation of pathologic fractures of the vertebral body using vertebroplasty procedures. Sacroplasty was not included.
SOURCES
Andresen, R., Radmer, S., Andresen, J.R., & Schober, H.C. (2017). Comparison of the 18-month outcome after the treatment of osteoporotic insufficiency fractures by means of balloon sacroplasty (BSP) and radiofrequency sacroplasty (RFS) in comparison: a prospective randomized study. European Spine Journal, 26 (12), 3235-3240. (Level 4 evidence)
BlueCross BlueShield Association. Evidence Positioning System. (5:2023). Percutaneous vertebroplasty and sacroplasty (6.01.25). Retrieved November 15, 2023 from www.bcbsaoca.com/eps/. (52 articles and/or guidelines reviewed)
Frey, M., Warner, C., Thomas, S., Johar, K., Sing, B., Mohammad, M., et al. (2017). Sacroplasty: a ten-year analysis of prospective patients treated with percutaneous sacroplasty: literature review and technical considerations. Pain Physician Journal, e1063-e1072. (Level 4 evidence)
Heo, D. & Park, C. (2017). Percutaneous sacroplasty for non-neoplastic osteoporotic sacral insufficiency fractures. Pain Physician, 20 (2), 89-94. (Level 4 evidence)
Mahmood, B., Pasternack, J., Razi, A., & Saleh, A. (2019). Safety and efficacy of percutaneous sacroplasty for treatment of sacral insufficiency fractures: a systematic review. Journal of Spine Surgery, 5 (3), 365-371. (Level 2 evidence)
ORIGINAL EFFECTIVE DATE: 4/1/2001
MOST RECENT REVIEW DATE: 1/11/2024
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