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Subtalar Arthroereisis (Artroereisis subtalar)
Número de política: MA 1.114
Beneficio clínico
- Minimizar el riesgo o la preocupación de seguridad.
- Minimizar las intervenciones dañinas o ineficaces.
- Garantizar el nivel de atención adecuado.
- Asegurar la duración adecuada del servicio para las intervenciones.
- Asegurar que se hayan cumplido los requisitos médicos recomendados.
- Asegurar el lugar apropiado para el tratamiento o servicio.
Effective Date: 1/1/2026
Política
Subtalar arthroereisis is considered investigational as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.
Variaciones del producto
This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Consulte la información adicional a continuación.
FEP PPO - Consulte el Manual de Políticas Médicas de FEP.
Descripción/Antecedentes
Subtalar arthroereisis has been performed for more than 50 years, with a variety of implant designs and compositions. The Maxwell-Brancheau Arthroereisis implant is the most frequently used, although other devices such as the HyProCure® subtalar arthroereisis implant, and Kalix® devices are also available. The Maxwell-Brancheau Arthroereisis implant is designed to be reversible and easy to insert, while the additional advantage is that it does not require bone cement. In children, insertion of the Maxwell-Brancheau Arthroereisis implant may be offered as a standalone procedure, although often used in combination with other procedures to correct additional deformities.
Regulatory Status
A number of implants have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process, and are summarized in Table 1. In general, these devices are indicated for insertion into the sinus tarsi of the foot, allowing normal subtalar joint motion while blocking excessive pronation.
Table 1. Representative Subtalar Implant Devices Cleared by FDA
Device |
Fabricante |
Fecha |
510(k) |
|---|---|---|---|
|
Subtalar MBA® |
Integra LifeSciences |
07/96 |
K960692 |
|
OsteoMed Subtalar Implant System |
OsteoMed |
08/03 |
K031155 |
|
BioPro Subtalar Implant |
BioPro |
09/04 |
K041936 |
|
HyProCure Subtalar Implant System |
Graham Medical Technologies |
09/04 |
K042030 |
|
MBA Resorb Implant |
Kinetikos Medical |
09/05 |
K051611 |
|
Metasurg Subtalar Implant |
Metasurg |
05/07 |
K070441 |
|
Subtalar Implant |
Biomet Sports Medicine |
07/07 |
K071498 |
|
Arthrex ProStop Plus Arthroereisis Subtalar Implant |
Arthrex |
01/08 |
K071456 |
|
Trilliant Surgical Subtalar Implant |
Trilliant Surgical |
02/11 |
K103183 |
|
Metasurg Subtalar Implant |
Metasurg |
08/11 |
K111265 |
|
NuGait™ Subtalar Implant System |
Ascension Orthopedic |
08/11 |
K111799 |
|
Disco Subtalar Implant |
Trilliant Surgical |
12/11 |
K111834 |
|
OsteoSpring FootJack Subtalar Implant System |
OsteoSpring Medical |
12/11 |
K112658 |
|
IFS Subtalar Implant |
Internal Fixation Systems |
12/11 |
K113399 |
|
The Life Spine Subtalar Implant System |
Life Spine |
06/16 |
K160169 |
An FDA 510(k) database search product code HWC (03/08/18).
Fundamento
Summary of Evidence
For individuals who have flatfoot who receive STA, the evidence includes mainly single-arm case series and a small nonrandomized controlled trial comparing STA with lateral column calcaneal lengthening. Relevant outcomes are symptoms, functional outcomes, and quality of life. The small nonrandomized comparative trial (n=24 feet) is considered preliminary, and interpretation of the case series evidence is limited by the lack of adequate comparators in addition to STA, creating difficulties in determining the extent to which each modality contributes to the outcomes. Another limitation of the published data is the lack of long-term outcomes, which is of particular importance because the procedure is often performed in growing children. Although some authors have reported rates of symptom improvement, the current evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have talar subluxation joint dislocation who receive subtalar arthroereisis, the evidence consists of 1 prospective, single-arm study of talocalcaneal stabilization using HyProCure®. Relevant outcomes are symptoms, functional outcomes, and quality of life. Although improvements in pain and function were observed, the current evidence on the use of subtalar arthroereisis for treatment of talar subluxation joint dislocation is insufficient to draw conclusions about treatment effectiveness. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Definiciones
Calcaneus is the largest of the tarsal bones situated at the lower and back part of the foot forming the heel.
Talus is the ankle bone; the bone of the tarsus which articulates with the tibia at the ankle.
Exención de responsabilidad
Las políticas médicas de Capital Blue Cross se utilizan para determinar la cobertura de tecnologías, procedimientos, equipos y servicios médicos específicos. Estas políticas médicas no constituyen un consejo médico y están sujetas a cambios según lo exija la ley o la evidencia clínica aplicable de las pautas de tratamiento independientes. Los proveedores que brindan tratamiento son individualmente responsables de los consejos médicos y el tratamiento de los miembros. Estas políticas no son una garantía de cobertura o pago. El pago de las reclamaciones está sujeto a la determinación del programa de beneficios del miembro y la elegibilidad en la fecha del servicio, y a la determinación de que los servicios son médicamente necesarios y apropiados. El procesamiento final de una reclamación se basa en los términos del contrato que se aplican al programa de beneficios de los miembros, incluidas las limitaciones y exclusiones de beneficios. Si un proveedor o miembro tiene alguna pregunta sobre esta política médica, debe comunicarse con Servicios para proveedores o Servicios para miembros de Capital Blue Cross.
Coding Information
Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. La identificación de un código en esta sección no denota cobertura, ya que la cobertura está determinada por los términos de la información de beneficios del miembro. Además, no todos los servicios cubiertos son elegibles para un reembolso por separado. Los códigos deben estar en orden numérico.
Investigational; therefore, not covered:
Códigos de procedimiento |
||||
|
0335T |
0510T |
0511T |
28899 |
|
Referencias
- Chong DY, Macwilliams BA, Hennessey TA, et al. Prospective comparison of subtalar arthroereisis with lateral column lengthening for painful flatfeet. J Pediatr Orthop B. Jul 2015;24(4):345-353. PMID 25856275
- Metcalfe SA, Bowling FL, Reeves ND. Subtalar joint arthroereisis in the management of pediatric flexible flatfoot: a critical review of the literature. Foot Ankle Int. Dec 2011;32(12):1127-1139. PMID 22381197
- Graham ME, Jawrani NT, Chikka A. Extraosseous talotarsal stabilization using HyProCure(R) in adults: a 5-year retrospective follow-up. J Foot Ankle Surg. Jan-Feb 2012;51(1):23-29. PMID 22196455
- Vedantam R, Capelli AM, Schoenecker PL. Subtalar arthroereisis for the correction of planovalgus foot in children with neuromuscular disorders. J Pediatr Orthop. May-Jun 1998;18(3):294-298. PMID 9600551
- Nelson SC, Haycock DM, Little ER. Flexible flatfoot treatment with arthroereisis: radiographic improvement and child health survey analysis. J Foot Ankle Surg. May-Jun 2004;43(3):144-155. PMID 15181430
- Needleman RL. A surgical approach for flexible flatfeet in adults including a subtalar arthroereisis with the MBA sinus tarsi implant. Foot Ankle Int. Jan 2006;27(1):9-18. PMID 16442023
- Cicchinelli LD, Pascual Huerta J, Garcia Carmona FJ, et al. Analysis of gastrocnemius recession and medial column procedures as adjuncts in arthroereisis for the correction of pediatric pes planovalgus: a radiographic retrospective study. J Foot Ankle Surg. Sep-Oct 2008;47(5):385-391. PMID 18725117
- Lucaccini C, Zambianchi N, Zanotti G. Distal osteotomy of the first metatarsal bone in association with sub-talar arthroerisis, for hallux valgus correction in abnormal pronation syndrome. Chir Organi Mov. Dec 2008;92(3):145-148. PMID 19082522
- Scharer BM, Black BE, Sockrider N. Treatment of painful pediatric flatfoot with Maxwell-Brancheau subtalar arthroereisis implant a retrospective radiographic review. Foot Ankle Spec. Apr 2010;3(2):67-72. PMID 20400415
- Brancheau SP, Walker KM, Northcutt DR. An analysis of outcomes after use of the Maxwell-Brancheau Arthroereisis implant. J Foot Ankle Surg. Jan-Feb 2012;51(1):3-8. PMID 22196453
- Bresnahan PJ, Chariton JT, Vedpathak A. Extraosseous talotarsal stabilization using HyProCure(R): preliminary clinical outcomes of a prospective case series. J Foot Ankle Surg. Mar-Apr 2013;52(2):195-202. PMID 23313499
- Scher DM, Bansal M, Handler-Matasar S, et al. Extensive implant reaction in failed subtalar joint arthroereisis: report of two cases. HSS J. Sep 2007;3(2):177-181. PMID 18751791
- Saxena A, Nguyen A. Preliminary radiographic findings and sizing implications on patients undergoing bioabsorbable subtalar arthroereisis. J Foot Ankle Surg. May-Jun 2007;46(3):175-180. PMID 17466243
- Cook EA, Cook JJ, Basile P. Identifying risk factors in subtalar arthroereisis explantation: a propensity-matched analysis. J Foot Ankle Surg. Jul-Aug 2011;50(4):395-401. PMID 21708340
- National Institute for Health and Care Excellence (NICE). Sinus Tarsi Implant Insertion for Mobile Flatfoot [IPG305]. 2009
- Harris EJ, Vanore JV, Thomas JL, et al. Clinical Practice Guideline Pediatric Flatfoot Panel: American College of Foot and Ankle Surgeons (ACFAS). Diagnosis and treatment of pediatric flatfoot. J Foot Ankle Surg. Nov-Dec 2004;43(6):341-373. PMID 15605048
- Lee MS, Vanore JV, Thomas JL, et al. Clinical Practice Guideline Adult Flatfoot Panel: American College of Foot and Ankle Surgeons (ACFAS). Diagnosis and treatment of adult flatfoot. J Foot Ankle Surg. Mar-Apr 2005;44(2):78-113. PMID 15768358
- Ghali, A., Mhapankar, A., Momtaz, D., Driggs, B., Thabet, A. M., & Abdelgawad, A. (2022). Arthroereisis: Treatment of Pes Planus. Cureus, 14(1), e21003.
- Turner C, Gardiner MD, Midgley A, Stefanis A. A guide to the management of paediatric pes planus. Aust J Gen Pract. 2020;49(5):245-249. doi:10.31128/AJGP-09-19-5089
- Piraino JA, Theodoulou MH, Ortiz J, et al. American College of Foot and Ankle Surgeons Clinical Consensus Statement: Appropriate Clinical Management of Adult-Acquired Flatfoot Deformity. J Foot Ankle Surg. 2020; 59(2): 347-355. PMID 32131002
- Bernasconi A, Lintz F, Sadile F. The role of arthroereisis of the subtalar joint for flatfoot in children and adults. EFORT Open Rev. 2017;2(11):438-446. Published 2017 Nov 8. doi:10.1302/2058-5241.2.170009
Historial de políticas
- MA 1.114
- 8/5/2025 Creation of policy.
Visualizador de contenido web - Contenido reparado
Actualización: 1 de enero de 2026
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