Percutaneous sacroplasty involves the injection of radiopaque bone cement, usually polymethyl-methacrylate (PMMA), into sacral insufficiency fractures (SIFs) for stabilization. It has been proposed that this procedure may provide an analgesic effect through mechanical stabilization of a fractured or weakened vertebral body. Sacroplasty requires fluoroscopic or ultrasound guidance. There is risk of the bone cement migrating out of place (called extravasation). In some cases, this has led 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 patients 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.
Percutaneous sacroplasty for all indications is considered investigational.
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We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
There is a lack of randomized controlled trials on percutaneous sacroplasty for sacral insufficiency. The small numbers of treated individuals in cohort studies and retrospective reviews leave uncertainty regarding the impact of sacroplasty on health outcomes.
The use of polymethylmethacrylate (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.
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. Abstract retrieved March 14, 2019 from PubMed database.
BlueCross BlueShield Association. Evidence Positioning System. (4:2018). Percutaneous vertebroplasty and sacroplasty (6.01.25). Retrieved March 14, 2019 from https://www.evidencepositioningsystem. (45 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, 2017, e1063-e1072. (Level 4 evidence)
Heo, D., and Park, C. (2017). Percutaneous sacroplasty for non-neoplastic osteoporotic sacral insufficiency fractures. Pain Physician, 20 (2), 89-94. Abstract retrieved April 20, 2018 from PubMed database.
Winifred S. Hayes, Inc. Health Technology Brief. (2018, November). Percutaneous sacroplasty for treatment of sacral insufficiency fractures. Retrieved March 14, 2019 from https://www.hayesinc.com/subscribers. (20 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 4/1/2001
MOST RECENT REVIEW DATE: 4/11/2019
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