Subtalar Arthroereisis
DESCRIPTION
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 but are not limited to: Subtalar MBA®, OsteoMed Subtalar Implant System, BioPro Subtalar Implant, HyProCure Subtalar Implant System, MBA Resorb Implant, Metasurg Subtalar Implant, Subtalar Implant, Arthrex ProStop Plus Arthroereisis Subtalar Implant, Trilliant Surgical Subtalar Implant, NuGait™ Subtalar Implant System, Disco Subtalar Implant, OsteoSpring FootJack Subtalar Implant System, IFS Subtalar Implant, and The Life Spine Subtalar Implant System.
POLICY
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.
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
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.
SOURCES
American College of Foot and Ankle Surgeons. (2020). American College of Foot and Ankle Surgeons clinical consensus statement: Appropriate clinical management of adult-acquired flatfoot deformity. Retrieved August 15, 2022 from https://www.acfas.org.
BlueCross BlueShield Association. Evidence Positioning System. (5:2023). Subtalar arthroereisis (7.01.104). Retrieved September 20, 2023 from www.bcbsaoca.com/eps/. (18 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.
Franz, A., Herz, D., Raabe, J., Seeberger, U., & Bollmann, C. (2021). Pedobarographic outcome after subtalar screw arthroereisis in flexible juvenile flatfoot. Foot and ankle surgery: Official Journal of the European Society of Foot and Ankle Surgeons, 27 (4), 389-394. Abstract retrieved August 15, 2022 from PubMed database.
Mattesi, L., Ancelin, D., & Severyns, M.P. (2021). Is subtalar arthroereisis a good procedure in adult - acquired flatfoot? A systematic review of the literature. Orthopaedics & Traumatology: Surgery & Research, 107 (6), 103002. (Level 2 evidence)
Mazotti, A., Viglione, V., Gerardi, S., Artioloi, E., Rocca, G., & Faldini, C. (2023). Subtalar arthroereisis post – operative management in children: A literature review. The Foot, 56:102037. Doi: 10.1016/j.foot.2023.102037. Abstract retrieved September 21, 2023 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.
Saxena, A., Via, A., Maffulli, N., & 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.
Smith, C., Zaidi, R., Bhamra, J., Bridgens, A., Wek, C., & Kokkinakis, M. (2021). Subtalar arthroereisis for the treatment of the symptomatic paediatric flexible pes planus: a systematic review. EFORT Open Reviews, 6 (2), 118–129. (Level 1 evidence)
Suh, D.H., Park, J.H., Lee, S.H., Kim, H.J., Park, Y.H., Jang, W.Y., 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.
Tan, J.H.I., Tan, S.H.S., Lim, A.K.S., & Hui, J.H. (2021). The outcomes of subtalar arthroereisis in pes planus: a systemic review and meta-analysis. Archives of Orthopaedic and Trauma Surgery, 141 (5), 761-773. Abstract retrieved May 19, 2021 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.
Winifred S. Hayes, Inc. Health Technology Assessment. (2020, January; last update search February 2023). Subtalar arthroeresis for the treatment of pediatric flatfoot. Retrieved September 21, 2023 from www.Hayesinc.com/subscribers. (23 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Health Technology Assessment. (2020, March; last update search February 2023). Subtalar arthroeresis for the treatment of adult-acquired flatfoot deformity. Retrieved September 21, 2023 from www.Hayesinc.com/subscribers. (23 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 4/13/2006
MOST RECENT REVIEW DATE: 11/9/2023
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