Arthroereisis is a surgical procedure that purposely limits movement across a joint. Subtalar arthroereisis or extraosseous talotarsal stabilization is designed to correct excessive talar displacement and calcaneal eversion by reducing pronation across the subtalar joint. Subtalar arthroereisis is being evaluated as a treatment of flexible flatfoot and talotarsal joint dislocation. It is performed by placing an implant in the sinus tarsi, which is a canal located between the talus and the calcaneus. Conservative treatments include orthotics or shoe modifications.
A number of implants have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process since 1996. These include: Subtalar MBA®, OsteoMed Subtalar Implant System, BioPro Subtalar Implant, HyProCure Subtalar Implant System, MBA Resorb Implant, Metasurg Subtalar Implant and Subtalar Implant.
Subtalar arthroereisis for the treatment of talar displacement and calcaneal eversion, including, but not limited to, flexible flatfoot and talotarsal joint dislocation is considered investigational.
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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The evidence for subtalar arthroereisis includes mainly single-arm case series and one small nonrandomized controlled trial. Some studies report high rates of complications and implant removal. The evidence is insufficient to determine the effects of the technology on health outcomes.
BlueCross BlueShield Association. Evidence Positioning System. (4:2018).Subtalar arthroereisis (7.01.104). Retrieved October 11, 2019 from https://www.evidencepositioningsystem.com/. (15 articles and/or guidelines reviewed)
Bresnahan, P.J., Chariton, J.T., & Vedpathak, A. (2013). Extraosseous talotarsal stabilization using HyProCure®: preliminary clinical outcomes of a prospective case series. Journal of Foot and Ankle Surgery, 52 (2), 195-202. Abstract retrieved November 7, 2018 from PubMed database.
Caravaggi, P., Lullini, G., Berti, L., Giannini, S., & Leardini, A. (2018). Functional evaluation of bilateral subtalar arthroereisis for the correction of flexible flatfoot in children: 1-year follow-up. Gait and Posture, 64, 152-158. Abstract retrieved November 6, 2018 from PubMed database.
Chong, D. Y., Macwilliams, B. A., Hennessey, T. A., Teske, N., & Stevens, P. M. (2015). Prospective comparison of subtalar arthroereisis with lateral column lengthening for painful flatfeet. Journal of Pediatric Orthopaedics, Part B, 24 (4), 345-353. Abstract retrieved January 27, 2017 from PubMed database.
National Institute for Health and Care Excellence. (2009, July). Sinus tarsi implant insertion for mobile flatfoot. Retrieved November 6, 2018 from http://www.nice.org.uk/guidance/ipg305.
Saxena, A., Via, A., Maffulli, N., and Chiu, H. (2016). Subtalar arthroereisis implant removal in adults: a prospective study of 100 patients. Journal of Foot & Ankle Surgery, 55 (3), 500-503. Abstract retrieved January 12, 2018 from PubMed database.
Shah, N., Needleman, R., Bokhari, O., & Buzas, D. (2015). 2013 subtalar arthroereisis survey: the current practice patterns of members of the AOFAS. Foot & Ankle Specialist, 8 (3), 180-185. Abstract retrieved March 2, 2016 from PubMed database.
Suh, DH., Park, JH., Lee, SH., Kim, HJ., Park, YH., Jang, WY., et al. (2019) Lateral column lengthening versus subtalar arthroereisis for paediatric flatfeet: a systematic review. International Orthopaedics, 43 (5), 1179-1192. Abstract retrieved October 11, 2019 from PubMed database.
U. S. Food and Drug Administration. (2006, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K053543. Retrieved January 14, 2010 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2006, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K061765. Retrieved August 30, 2013 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2009, May). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K081755. Retrieved August 30, 2013 from http://www.accessdata.fda.gov.
MOST RECENT REVIEW DATE: 11/14/2019
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