Coverage Policy Manual
Policy #: 1998151
Category: Surgery
Initiated: August 2017
Last Review: February 2024
  Arthroereisis for Pes Planus (Flat Feet) (Subtalar stabilization)
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. Extraosseous talotarsal stabilization is also being evaluated as a treatment of 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.
 
Flexible flatfoot is a common disorder, anatomically described as excessive pronation during weight-bearing due to anterior and medial displacement of the talus. It may be congenital, or it may be acquired in adulthood due to posterior tibial tendon dysfunction, which in turn may be caused by trauma, overuse, inflammatory disorders, and other factors. Symptoms include dull, aching and throbbing, cramping pain, which in children may be described as growing pains. Additional symptoms include refusal to participate in athletics or walking long distances.
 
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 reported, although other devices such as the HyProCure, subtalar arthroereisis peg, and Kalix are also described in the medical literature. The Maxwell-Brancheau Arthroereisis implant is described as reversible and easy to insert, with the additional advantage that it does not require bone cement. In children, insertion of the Maxwell-Brancheau Arthroereisis implant may be offered as a stand-alone procedure, although children and adults often require adjunctive surgical procedures on bone and soft tissue 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. In general, these devices are indicated for insertion into the sinus tarsi of the foot, allowing normal subtalar joint motion while blocking excessive pronation.
 
Subtalar MBA® (Integra LifeSciences) received U.S. Food and Drug Administration (FDA) marketing clearance in 1996 (K960692)
OsteoMed Subtalar Implant System (OsteoMed) received U.S. FDA marketing clearance in 2003 (K031155)
BioPro Subtalar Implant (BioPro) received U.S. FDA marketing clearance in 2004 (K041936)
HyProCure Subtalar Implant System (Graham Medical Technologies) received U.S. FDA marketing clearance in 2004 (K042030)
MBA Resorb Implant (Kinetikos Medical) received U.S. FDA marketing clearance in 2005 (K051611)
Metasurg Subtalar Implant (Metasurg) received U.S. FDA marketing clearance in 2007 (K070441)
Subtalar Implant (Biomet Sports Medicine) received U.S. FDA marketing clearance in 2007 (K071498)
Arthrex ProStop Plus Arthroereisis Subtalar Implant (Arthrex) received U.S. FDA marketing clearance in 2008 (K071456)
Trilliant Surgical Subtalar Implant (Trilliant Surgical) received U.S. FDA marketing clearance in 2011 (K103183)
Metasurg Subtalar Implant (Metasurg) received U.S. FDA marketing clearance in 2011 (K111265)
NuGait™ Subtalar Implant System (Ascension Orthopedic) received U.S. FDA marketing clearance in 2011 (K111799)
Disco Subtalar Implant (Trilliant Surgical) received U.S. FDA marketing clearance in 2011 (K111834)
OsteoSpring FootJack Subtalar Implant System (OsteoSpring Medical) received U.S. FDA marketing clearance in 2011 (K112658)
IFS Subtalar Implant (Internal Fixation Systems) received U.S. FDA marketing clearance in 2011 (K113399)
The Life Spine Subtalar Implant System (Life Spine) received U.S. FDA marketing clearance in 2016 (K160169)
 
Initially there was not a specific CPT code for this procedure. It was appropriately billed with 28899.
 
On October 1, 2005, the following HCPCS code became available:
S2117: Arthroereisis, subtalar
Policy/
Coverage:
Effective February 2021
 
Treatment of pes planus is a contract exclusion in some member certificates of coverage.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Subtalar arthroereisis does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, subtalar arthroereisis is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective prior to February 2021
 
Arthroereisis has been performed by the Podiatric profession for 50 years, but unfortunately there are no long-term outcome studies on any of the various techniques.  Arthroereisis is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, arthroereisis is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
Treatment of pes planus is an exclusion in the member certificate of coverage.
Rationale:
A review of the literature finds no randomized controlled trials and no comparative studies for effectiveness.
 
2006-2007 Update
A search of the MEDLINE database for the period of September 2005 through January 2007 found no evidence to prompt a change in the policy statement. Several retrospective case series were published. One of these reported significant improvements in pain and function in 78% of patients (23 patients, 28 feet) with use of a subtalar implant as a component of reconstructive foot and ankle surgery. (Needleman, 2006) However, since results were not compared with controls receiving reconstructive surgery without subtalar arthroereisis, the contribution of the implants to these outcomes is unclear. In addition, the authors reported an overall complication rate of 46% with surgical removal of 39% of the implants due to sinus tarsi pain. The authors also commented that postoperative sinus tarsi pain was unpredictable. No prospective controlled studies were identified.
 
2008 Update
A search of the MEDLINE database for the period of February 2007 through March 2008 identified one radiographic study of bioabsorbable subtalar arthroereisis. (Saxena, Nguyen 2007) Six patients met the inclusion criteria and consented to additional imaging with an average follow-up of 14 months (range of 12-50 months). Two patients requested implant removal; a third had persistent pain but refused explantation. Radiographic measurement (MRI or CT) found that these 3 patients had smaller tarsal canal widths than the diameter of the inserted interference screw. The authors noted that the implant length also had to be reduced prior to implantation. They concluded that the current width and length of commercially available implants may need to be modified, and that more research and long-term clinical study are needed. Subtalar arthroereisis has not been shown to be as beneficial as established alternatives and the policy statement remains unchanged.
 
2012 Update
The policy is being updated with a literature search using the MEDLINE database through July 2012.  There was no new literature identified that would prompt a change in the coverage statement.
 
Several case series with small numbers of patients were identified reporting outcomes of a combination of surgical interventions in which STA was one component. For example, Adelman and colleagues, in a study from the United States, reported on a retrospective analysis of 10 patients (Adelman, 2008). The authors described this as a pilot study, and they reported on changes in 7 radiographic measurements. Cicchinelli et al. in a study from Spain, also reported on radiographic outcomes in a retrospective analysis of 28 feet in 20 pediatric patients treated with STA combined with gastrocnemius recession or with STA combined with gastrocnemius recession and medial column reconstruction (Cicchinelli, 2008).  The authors reported that gastrocnemius recession had a notable effect on correction of transverse plane deformity when used as an adjunct to STA; however, medial column reconstruction had a negative impact on the degree of correction in the transverse plane when used as an adjunct to STA and gastrocnemius recession. In another study from Europe, Lucaccini et al. analyzed clinical and radiographic results of 14 patients (16 feet) with hallux valgus in abnormal pronation syndrome treated with distal osteotomy of the first metatarsal bone and STA performed in one stage (Lucaccini, 2008).  In a U.S. study from 2010, Scharer and colleagues conducted a retrospective radiographic evaluation of 39 patients (68 feet) who had received the MBA implant for the treatment of painful pediatric flatfoot deformities (Scharer, 2010). The average age of the patients at the time of surgery was 12 years (range: 6-16 years). Additional procedures included 12 (18%) gastrocnemius recessions, 6 (9%) Achilles tendon lengthening, and 4 (6%) Kidner procedures. At an average 24-month follow-up (range: 6-61 months), there had been 10 (15%) complications requiring reoperation, including implant migration, undercorrection, overcorrection, and persistent pain. The implants were exchanged for either a larger or smaller implant. These case series do not allow comparison with nonsurgical interventions or with other surgical interventions.
 
Cook et al. reported a retrospective case-control study in 2011 to identify factors that may contribute to failure (explantation) of titanium arthroereisis implants (Cook, 2011).  All patients who required removal of a self-locking wedge-type subtalar arthroereisis (n=22) were compared in a 1:2 ratio (n=44) to patients with nonexplanted arthroereises who were treated during the same time period. Subjects were matched for preoperative radiographic measurements, age, gender, presenting diagnosis, and length of follow-up. Multivariate logistic regression showed no significant effect of age, gender, implant size, shape, length of follow-up, implant position, surgeon experience, or concomitant procedures. Patients who required explantation had slightly greater odds of radiographic undercorrection (odds ratio [OR] 1.175) or residual transverse plane-dominant deformities (OR: 1.096). The percentage of explantations in this retrospective analysis was not described.
 
2013 Update
A literature search conducted using the MEDLINE database through July 2012 did not identify any new information that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
 
In 2011, Metcalfe et al. published a systematic review of the literature on subtalar arthroereisis for pediatric flexible flatfoot. (Metcalfe, 2011)  Seventy-six case series or case reports (no controlled trials) were identified. Ten of the studies (756 feet) provided clinician-based assessment of the surgical result graded from “excellent to poor” with follow-up between 36 and 240 months. Six studies (212 feet) included estimates of overall patient satisfaction using non-validated outcome measures, while 1 study (16 feet) found significant improvement using a validated foot-specific patient outcome measure. Data from 15 studies that reported radiographic values were combined for analysis. Although 8 of 9 radiographic parameters showed statistically significant improvements following arthroereisis procedures, the relationship between radiographic and clinical outcomes is uncertain. The procedure was associated with a number of complications including sinus tarsi pain, device extrusion, and undercorrection. Complication rates ranged from 4.8% to 18.6%, with unplanned removal rates between 7.1% and 19.3% across all device types. The influence of adjunctive procedures on outcomes was not addressed in this review.
 
A retrospective study was published in 2012 (Brancheau, 2012) which reported mean 36-month follow-up (range 18 to 48 months) in 35 patients (60 feet) after use of the Maxwell-Brancheau Arthroereisis (MBA) implant with adjunct procedures. The mean age of the patients was 14.3 years (range, 5 to 46 years). Significant changes were observed in radiographic measures (talocalcaneal angle, calcaneocuboid angle, first to second intermetatarsal angle, calcaneal inclination angle, and talar declination angle). Seventeen percent of patients reported that 9 implants (15%) were removed after the initial surgery. Of the 24 patients (68.6%) who answered a subjective questionnaire (in person or by telephone at a mean of 33 months postoperatively), 95.8% reported resolution of the chief presenting complaint, and 79.2% said they were 100% satisfied with their surgical outcome. The contribution of the MBA implant to these results cannot be determined by this study design.
 
One case series that was not confounded by adjunctive procedures and that had a relatively long follow-up was published by Graham et al. in 2012. This study reported mean 51-month follow-up of talotarsal stabilization in 117 feet using the HyProCure device (Graham, 2012). Patients who received adjunctive procedures affecting the talotarsal joint were excluded from the analysis. Adult patients who met the inclusion/exclusion criteria were invited to participate in the study. Eighty-three patients gave consent to participate, and 78 completed the Maryland Foot Score Questionnaire; 5 patients who had 7 implants (6%) removed did not complete the questionnaire. There were 16 revision surgeries with HyProCure; 9 involved repositioning of a partially displaced device or a change in size of the device. Of the patients who retained the device, 52% reported complete alleviation of foot pain, 69% had no limitations on their foot functional abilities, and 80% of cases reported complete satisfaction with the appearance of their feet. This case series is notable for its assessment of functional outcomes at medium-term follow-up in patients who did not have adjunct procedures.
 
2014 Update
A literature search conducted through August 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Talotarsal Joint Dislocation
In 2013, Bresnahan et al reported a prospective study of talotarsal stabilization using HyProCure® in 46 feet of 35 patients diagnosed with recurrent and/or partial talotarsal joint dislocation (Bresnahan, 2013). Patients who had the following characteristics were included: deformity characterized by talar displacement medially, plantarly, and/or anteriorly; collapse of the medial longitudinal arch; hyperpronation about the subtalar joint axis; ability to manipulate the foot to correct the deformity; a prolonged period of pronation or delayed resupination and/or flattening of the arch; and anteroposterior/dorsoplantar and lateral weight-bearing radiographs revealing talotarsal misalignment. No procedures besides insertion of the HyProCure® device were performed to address the talotarsal joint dislocation. At 1 year postoperatively, scores on the Maryland Foot Score had improved from a preoperative score of 69.53 to a postoperative score of 89.27 of 100 (n=30). Foot pain decreased by 37.0%, foot functional activities improved by 14.4%, and foot appearance improved by 29.5%. Implants were removed from 2 feet with no unresolved complications
 
2016 Update
A literature search conducted through January 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In 2015, Chong and colleagues reported a small prospective nonrandomized trial that compared STA with lateral column calcaneal lengthening for the treatment of 24 painful flatfeet in children (Chong, 2015). Seven children (13 feet) enrolled at the Primary Children’s Medical Center were treated with arthroereisis and 8 children (11 feet) enrolled at the Shriners Hospital for Children were treated with lateral column lengthening. Children who underwent STA had a small incision with insertion of the implant and were placed in below-knee walking casts for 3 weeks. Children treated with lateral column lengthening had an opening wedge osteotomy with insertion of a wedge of cadaveric bone and were placed in non-weight-bearing casts for 1 month and walker type boots for another month. Outcomes at a mean of 12.7 months after surgery included radiographs, foot pressure, kinematic analysis and the Oxford Ankle-Foot Questionnaire for Children. The 2 groups showed similar improvements in the lateral talo-first metatarsal angle and talonavicular coverage and in kinematics. Both groups showed a statistically significant lateralization of the hindfoot and midfoot center of pressure (p<0.01). There were no between-group differences in any of the clinical or functional outcomes. On within-group comparison, only the STA group had a statistically significant reduction in time on the hindfoot (p=0.01). Both groups had improvements in the parental and child scores on the Oxford questionnaire, but only the STA group had a statistically significant improvement in this small sample. There were 2 complications in each group, with removal of the hardware in 1 patient and removal of the implant in 2 patients. The improvement in pain and foot position was retained following implant removal.
 
Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in January 2016 did not identify any ongoing or unpublished trials that would likely influence this review.
 
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2018. No new literature was identified that would prompt a change in the coverage statement.
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2019. No new literature was identified that would prompt a change in the coverage statement.
 
2020 Update
A literature search was conducted through January 2020.  There was no new information identified that would prompt a change in the coverage statement.  
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2021. No new literature was identified that would prompt a change in the coverage statement.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2023. No new literature was identified that would prompt a change in the coverage statement.
 
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2024. No new literature was identified that would prompt a change in the coverage statement.
CPT/HCPCS:
0335TInsertion of sinus tarsi implant
0510TRemoval of sinus tarsi implant
0511TRemoval and reinsertion of sinus tarsi implant
28446Open osteochondral autograft, talus (includes obtaining graft[s])
28899Unlisted procedure, foot or toes
S2117Arthroereisis, subtalar
References: Adelman VR, Szczepanski JA, Adelman RP.(2008) Radiographic evaluation of endoscopic gastrocnemius recession, subtalar joint arthroereisis, and flexor tendon transfer for surgical correction of stage II posterior tibial tendon dysfunction: a pilot study. J Foot Ankle Surg 2008; 47(5):400-8.

Bernasconi A, Lintz F, Sadile F.(2017) The role of arthroereisis of the subtalar joint for flatfoot in children and adults. EFFORT Open Rev. 2017 Nov 8;2(11):438-446. doi: 10.1302/2058-5241.2.170009. eCollection 2017 Nov.

Brancheau S, Maxwell J, Ritchey KL, et al.(1996) The Valenti STJ Arthroereisis Implant: A Ten-Year Retrospective Study. Reconstructive Surg Foot Leg; Update 1996; Chapter 8; pp 44-53.

Brancheau SP, Walker KM, Northcutt DR.(2012) An analysis of outcomes after use of the Maxwell-Brancheau Arthroereisis implant. J Foot Ankle Surg 2012; 51(1):3-8.

Bresnahan PJ, Chariton JT, Vedpathak A.(2013) Extraosseous talotarsal stabilization using HyProCure®: preliminary clinical outcomes of a prospective case series. J Foot Ankle Surg. Mar-Apr 2013;52(2):195-202. PMID 23313499

Chong DY, MacWilliams BA, Hennessey TA, et al.(2015) Prospective comparison of subtalar arthroereisis with lateral column lengthening for painful flatfeet. J Pediatr Orthop B. Jul 2015;24(4):345-353. PMID 25856275

Cicchinelli LD, Pascual Huerta J, Garcia Carmona FJ et al.(2008) 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 2008; 47(5):385-91.

Cohen-Sobel E, Giorgin R, Velez Z.(1995) Combined Technique for Surgical Correction of Pediatric Severe Flexible Flatfoot. J Foot Ankle Surg 1995; 34:183-94.

Cook EA, Cook JJ, Basile P.(2011) Identifying Risk Factors in Subtalar Arthroereisis Explantation: A Propensity-matched Analysis. J Foot Ankle Surg 2011; 50(4):395-401.

Graham ME, Jawrani NT, Chikka A.(2012) Extraosseous talotarsal stabilization using HyProCure(R) in adults: a 5-year retrospective follow-up. J Foot Ankle Surg 2012; 51(1):23-9.

Kubo H, Lipp C, Hufeland M, Ruppert M, et al.(2019) Outcome after subtalar screw arthroereisis in children with flexible flatfoot depends on time of treatment: Midterm results of 95 cases. J Orthop Sci. 2019 Jun 26. pii: S0949-2658(19)30190-3. doi: 10.1016/j.jos.2019.06.007. [Epub ahead of print]

Lee MS, Vanore JV, et al.(2005) Diagnosis and treatment of adult flatfoot. J Foot Ankle Surg, 2005; 44:78-113.

Lucaccini C, Zambianchi N, Zanotti G.(2008) Distal osteotomy of the first metatarsal bone in association with sub-talar arthroerisis, for hallux valgus correction in abnormal pronation syndrome. Chir Organi Mov 2008; 92(3):145-8.

Metcalfe SA, Bowling FL, Reeves ND.(2011) Subtalar joint arthroereisis in the management of pediatric flexible flatfoot: a critical review of the literature. Foot Ankle Int 2011; 32(12):1127-39.

Needleman RL.(2006) A surgical approach for flexible flat feet in adults including a subtalar arthroereisis with the MBA sinus tarsi implant. Foot Ankle Int, 2006; 27:9-18.

Saxena A, Nguyen A.(2007) Preliminary radiographic findings and sizing implications on patients undergoing bioabsorbable subtalar arthroereisis. J Foot Ankle Surg, 2007; 46:175-80.

Scharer BM, Black BE, Sockrider N.(2010) Treatment of painful pediatric flatfoot with Maxwell-Brancheau subtalar arthroereisis implant a retrospective radiographic review. Foot Ankle Spec 2010; 3(2):67-72.

Smith SD, Ocampo RF.(1997) Subtalar Arthroereisis and Associated Procedures. Clin Podiatr Med Surg 1997; 14:87-98.
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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