Medical Policy

 

Subject: Extraosseous Subtalar Joint Implantation and Subtalar Arthroereisis
Document #: SURG.00104 Publish Date:    10/17/2018
Status: Reviewed Last Review Date:    09/13/2018

Description/Scope

This document addresses the use of extraosseous subtalar joint implantation and subtalar arthroereisis.

Extraosseous subtalar joint implantation is a minimally invasive surgical procedure performed to stabilize and prevent redislocation of the talotarsal joint for symptoms associated with hyperpronation caused by partial talotarsal joint dislocation or talotarsal joint instability.

Subtalar arthroereisis is a surgical procedure performed to correct excessive talar displacement and calcaneal eversion due to pes planus (flatfoot) by placement of an implant in the sinus tarsi. Subtalar arthroereisis may be performed alone or in combination with other comprehensive surgical procedures for ankle and foot conditions.

Position Statement

Investigational and Not Medically Necessary:

  1. Subtalar arthroereisis is considered investigational and not medically necessary for all indications, including but not limited to the treatment of flatfoot conditions, symptomatic flexible flatfoot deformity, and posterior tibial tendon dysfunction.
  2. Extraosseous subtalar joint implantation is considered investigational and not medically necessary for all indications, including but not limited to, talotarsal joint stabilization.
Rationale

Subtalar Arthroereisis

Subtalar arthroereisis has been suggested both as an isolated procedure and as a component of a more comprehensive surgical procedure. As an isolated procedure, key outcomes of subtalar arthroereisis include short- and long-term improvement in symptoms and other functional outcomes such as walking, in addition to durability and other safety measures of the implant. When used as a component of a more comprehensive surgical procedure, controlled studies are needed to isolate the contribution of the arthroereisis to the overall treatment effect.

Adult Flatfoot Conditions
No randomized controlled trials (RCTs) have evaluated subtalar arthroereisis for treatment of adult flatfoot conditions, either as an isolated procedure or as part of a larger surgery. One retrospective comparative study evaluated subtalar arthroereisis as part of a comprehensive surgical procedure. The study, by Walley and colleagues (2018), was a retrospective case-control study comparing outcomes in 15 individuals who had surgical flatfoot correction (such as posterior tibial tendon resection or Achilles lengthening) plus an arthroereisis implant, and a matched control group of 30 individuals who had surgery without the implant. Mean duration of follow-up was 4.5 years for the experimental group and 3.4 years for controls for clinical outcome assessment. Clinical outcomes were assessed with the Short Form-36 (SF-36) and a visual analogue scale (VAS) ranging from 0 (no pain) to 10 (worst pain). At follow-up, SF-36 and VAS scores did not differ significantly between groups. The mean duration of radiographic follow-up was 2.4 years. At last follow-up, the lateral talar-first metatarsal angle (TIMA) improved significantly more in the experimental group than in the control group (p<0.05). The study had a small sample size, was non-randomized and retrospective and did not find that subtalar arthroereisis improved clinical outcomes.

A number of case series have been published (Adelman, 2008; Brancheau, 2012; Lucaccini, 2008; Needleman, 2006; Ozan, 2015). Most of these case series had small sample sizes. All of these included fewer than 50 individuals and most had fewer than 25 participants.

One of the larger case series was published by Brancheau and colleagues in 2012. This was  a retrospective study of 35 individuals (60 feet) treated with the Maxwell-Brancheau Arthroereisis (MBA) implant (Subtalar MBA® Implant System; Integra LifeSciences Corporation, Plainsboro, NJ) in adults and children with flexible flatfoot. The mean age of the participants at the time of surgery was 14.3 (range 5 to 46) years. Adjunct procedures were performed in 48 of the 60 cases (80%) based on the participants’ presenting complaints, diagnostic and intraoperative findings. Pre- and postoperative anteroposterior and lateral foot radiographs were compared at a mean of 36 months postoperatively. The mean changes were reported as statistically significant (p<0.00001) differences in five different talar/calcaneal/intermetararsal angles. It was noted, however, that correction of radiographic parameters is not always a reliable predictor of satisfaction with the surgical outcome.

A subgroup of 24 (68.6%) participants responded to a subjective questionnaire at a mean of 33 months postoperatively. The presenting chief complaints were resolved in 23 of 24 individuals (95.8%), and 21 of 24 individuals (87.5%) returned postoperatively to either the same or a greater activity level in sports. When asked to rate their pain, the subgroup reported that 24 of 40 feet (60%) were considered free of pain postoperatively, 13 of 40 feet (32.5%) experienced mild pain, and 3 of 40 feet (7.5%) were moderately painful. A total of 17 (71%) of the subgroup could stand for long periods of time without pain, however, 7 of the subgroup (29%) could not. A substantial number of participants (11.9%) experienced complications including pain and restricted motion of the subtalar joint, the most common complaint requiring implant removal. In addition to lacking a comparison group, the study is limited due to the large proportion of participants lost to follow-up, heterogeneity of the participants based on age (participants of all ages were included) and lack of blinding.

Pediatric Flatfoot Conditions
Metcalfe and colleagues (2012) performed a meta-analysis of the available literature regarding arthroereisis in children with flexible flatfoot. The literature consisted primarily of  case reports and retrospective case series; no RCTs were identified. Methodological variations include device type, inclusion criteria, surgical technique, application of adjunctive procedures and outcome measures. Few studies applied validated clinical or participant-reported outcome measures. While several studies demonstrated significant improvements in radiographic parameters including increased arch height and improved joint congruency following arthroereisis, the precise mechanism by which arthroereisis improves foot alignment remains to be explained. Calcaneal inclination angle demonstrated the least change with only small increases following arthroereisis. The procedure remains associated with a number of complications including sinus tarsi pain, device extrusion, and under-correction. Complication rates were reported to range between 4.8% and 18.6%, with unplanned removal rates between 7.1% and 19.3% across all device types. Satisfaction rates ranged from 79% to 100%. 

Subsequently, one prospective non-randomized comparative study was published.  The study, by Chong and colleagues (2015) compared subtalar arthroereisis and lateral column calcaneal lengthening in children (mean age: 12.8 years) with painful flatfeet.  A total of 7 individuals and 13 feet were in the arthroereisis group and 8 individuals and 11 feet were in the lateral column lengthening group.  Outcomes included five radiographic measures, of which only calcaneal pitch differed significantly between groups at follow-up.  Groups did not differ significantly at follow-up in kinematics outcomes (such as ankle and midfoot flexion/extension) or pedobarometry outcomes (such as time spent on the hindfoot).  Two complications were identified in each group.  The study had a small sample size and did not compare interventions on functional outcomes.

As noted above, most of the literature on subtalar arthroereisis for children with flatfoot conditions have been case series.  Nearly all of the published case series had sample sizes of fewer than 50 individuals each (Caravaggi, 2018, Cicchinelli, 2008; Kellermann, 2011; Koning, 2009; Nelson, 2004; Scharer, 2010).  In 2018, Faldini and colleagues published a retrospective case series in 173 children who had been followed for a mean of 49.5 months.  Children had undergone subtalar arthroereisis for flexible flatfoot using polymeric endo-orthotic implants.  Outcomes were assessed using the Italian Foot Function Index Questionnaire (FFI) which ranges from 0 to 162 with a lower score indicating a better outcome, and the Self-reported Foot and Ankle Score (SEFAS) which ranges from 0 to 48 with a higher score indicating a better outcome.  Baseline FFI and SEFAS scores were not reported.  The mean scores at follow-up were within the normal range; the mean FFI was 5.3 in males and 3.7 in females, and the mean SEFAS score was 47 in both males and females.  Implant removal surgery was performed in 4 of 173 individuals.  Limitations of this study and other series include lack of a control or comparison group and lack of blinding.

A smaller series with long-term follow-up was reported by Koning and colleagues (2009).  This series included 40 children (80 feet) with a mean age of 8 years of age (range, 4-11) who underwent subtalar arthroereisis for flexible pes planovalgus. Questionnaires from 27 participants (54 feet) were analyzed and clinical and radiographic results were evaluated for 44 feet. A total of 13 children were lost to follow-up. The mean follow-up was 12.6 years (range, 5.9-16.1 years). A total of 81% of the responders reported satisfaction with the results. Clinically, normal alignment was present in 14 feet, and mild deformities remained in 26 feet. The average foot angle measurements were radiographically normal. Several limitations of this study were acknowledged by the authors. In addition to its retrospective design and lack of comparison group, investigators were unable to compare the postoperative results to the preoperative situation because data were unavailable.

Other Conditions
There are no prospective controlled studies that evaluate the safety and efficacy of subtalar arthroereisis alone or in combination with other surgical procedures for adult or pediatric flatfoot conditions including symptomatic flexible flatfoot deformity. The available peer-reviewed literature consists of small retrospective case series, some that address specific surgical techniques and others that address procedures performed on cadavers or involve biomedical modeling and analysis.

Extraosseous Subtalar Joint Implantation for Talotarsal Stabilization

No RCTs or prospective non-randomized comparative studies have evaluated extraosseous subtalar joint implantation for talotarsal stabilization. Several case series evaluating the HyProCure® (GraMedica®, Macomb, MI) device have been published (Bresnahan 2013; Graham 2012a; Graham 2012b). The studies by Graham and colleagues were retrospective and the Bresnahan study was prospective. The Graham 2012b study had the largest sample size and longest-follow-up. All are limited by lack of comparison or control groups.

Graham and colleagues (2012a), retrospectively evaluated the long-term functional outcomes in adults (n=83) for treatment of symptoms associated with hyperpronation caused by partial talotarsal joint dislocation or talotarsal joint instability. Data on subjective outcomes of postoperative device performance was collected from a mailed questionnaire to participants. At a mean follow-up period of 51 months, 52% (41 of 78) of responders reported complete alleviation of foot pain and 69% (54 of 78) had no limitations on their foot functional capabilities. The implant was permanently removed from 7 of the 117 treated feet (6% removal rate) due to prolonged pain of the anterior talofibular ligament (4 cases), psychogenic reaction (2 cases), and postoperative infection (1 case). Excluding these explantations, an additional 16 participants underwent revision surgeries. Satisfaction with the appearance of their feet was reported in 80% (62 of 78) of cases. A total of 32% of the cases (35 of 110 feet in whom the implants were not removed) were performed with adjunctive procedures to achieve the desired amount of correction and thus the ability to draw conclusions on the efficacy of the HyProCure device as a standalone procedure is limited.

Bresnahan and colleagues (2013) prospectively reviewed subjective clinical outcomes in a multicenter case series of children and adults using the HyProCure device as a standalone procedure for the treatment of recurrent and/or partial talotarsal joint dislocation. A total of 35 individuals (46 feet) were evaluated using the Maryland Foot Score (MFS) questionnaire, obtained preoperatively and 1, 2, and 3 weeks, 1, 2, 3, and 6 months, and 1 year postoperatively. The mean overall scores showed gradual improvement from a preoperative value of 69.5 (± 19.6) to a postoperative value of 89.2 (± 14.4) at 1 year follow-up. Foot pain decreased by 37%, foot functional activities improved by 14%, and foot appearance improved by 29.5%. The greatest degree of improvement occurred at 4 weeks postoperatively, with gradual improvement continuing to the 1-year follow-up. At 6 months, 4 individuals (6 feet, 13%) showed a failure to improve from preoperative MFS, and at 1 year, 3 individuals (6 feet, 13%) showed no improvement. The HyProCure device was removed from 2 individuals (2 feet, 4%) due to discomfort when walking and during activities and failure of the procedure to relieve symptoms. Limitations of this study include the broad nature of the inclusion and exclusion criteria, including a lack of measurement of certain variables, such as the planar dominance of the recurrent talotarsal deformity, the presence of certain secondary conditions, and the relative activity level, all of which could have affected the subjective outcomes. There was a substantial number of cases lost to follow-up and incomplete data at the 1-year postoperative assessment, as 46 feet in 35 preoperative participants decreased to 30 feet in 21 participants.

Larger, longer-term, randomized and controlled studies are needed to fully evaluate the safety and efficacy of the HyProCure device for the treatment of extraosseous talotarsal joint dislocation.

Other Considerations

The American College of Foot and Ankle Surgeons (ACFAS) published two practice guidelines for the diagnosis and treatment of adult and pediatric flatfoot (Harris, 2004; Lee, 2005). In adults, the guideline stated:

…arthroereisis is seldom implemented as an isolated procedure. Because of the long-term compensation and adaptation of the foot and adjunctive structures for flatfoot function, other ancillary procedures are usually used for appropriate stabilization. Long-term results of arthroereisis in the adult flexible flatfoot patient have not been established. Some surgeons advise against the subtalar arthroereisis procedure because of the risks associated with implantation of a foreign material, the potential need for further surgery to remove the implant, and the limited capacity of the implant to stabilize the medial column sag directly (Lee, 2005).

In the pediatric population,

proponents of this procedure (arthroereisis) argue that it is a minimally invasive technique that does not distort the normal anatomy of the foot. Others have expressed concern about placing a permanent foreign body into a mobile segment of a child’s foot. The indication for this procedure remains controversial in the surgical community (Harris, 2004).

The American Association of Orthopaedic Surgeons has not taken a formal position with regard to the use of surgically placed implants as a treatment option for adult (acquired) flatfoot, flexible flatfoot in children, or in combination with other comprehensive surgical procedures for ankle and foot conditions.

In summary, the evidence in the peer-reviewed published literature is insufficient to draw conclusions as to the safety and effectiveness of extraosseous subtalar implants for talotarsal stabilization and subtalar arthroereisis with a surgically placed implant for the treatment of flatfoot deformity and other adult and pediatric ankle and foot conditions. Further research is required in the form of prospective controlled studies with long-term follow-up of functional improvement. This is particularly important given that the procedures may be performed in growing children.

Background/Overview

Flatfoot (also known as pes planus) is a common but often complex congenital or acquired condition, with diverse symptoms and varying degrees of deformity and disability, with the common characteristic of partial or total collapse of the arch of the foot. Flexible flatfoot, when the foot is flat when standing or weight-bearing and the arch returns when not standing, is one of the most common types, anatomically described as excessive pronation during weight bearing due to anterior and medial displacement of the talus. Flatfoot disorder is usually diagnosed in children as flexible flatfoot, paralytic flatfoot, or flatfoot associated with generalized ligamentous laxity, as seen in Marfan disease, Ehlers-Danlos Syndrome (EDS), Downs syndrome, cerebral palsy, myelomeningocele, developmental delay, and other syndromes. Flexible flatfoot in adults may be congenital or acquired due to posterior tibial tendon dysfunction (PTTD), which in turn may be caused by trauma, overuse, and inflammatory disorders (such as rheumatoid arthritis), among others. Symptoms include pain, with or without a dull aching, throbbing or cramping sensation which in children may be described as “growing pains.” In addition, flatfoot may contribute to symptoms of low back pain.

Conservative management of flexible flatfoot deformity includes orthotic therapy or shoe modifications, passive stretching exercises and medications such as nonsteroidal anti-inflammatory drugs. For an individual with more severe flatfoot deformity or ligamentous laxity in which ankle instability, PTTD, or early arthrosis has developed, an ankle-foot orthosis or a more proximal device may be more appropriate. A skeletally mature adolescent may benefit from these types of orthoses as a last line of nonsurgical treatment. Various surgical procedures including hind-, mid-, and forefoot osteotomies, soft tissue medial column reconstruction, and subtalar joint arthrodesis have been used in the treatment of individuals who have failed conservative treatment (Blitz, 2010).

Arthroereisis is the limitation of excessive movement across the joint. Subtalar arthroereisis is a surgical procedure designed to correct the excessive talar displacement and calcaneal eversion by placing an implant in the sinus tarsi, a canal located between the talus and the calcaneus. Subtalar arthroereisis has been performed alone or in combination with other surgical procedures of the ankle and foot.

Subtalar arthroereisis has been performed for over 50 years, with a variety of implant designs and compositions. The Maxwell Brancheau Arthroereisis (MBA) implant involves a simple and reversible implantation procedure, compared to other devices such as the STA-Peg and Kalix® II device (newdeal® SAS, Integra™, Intergra LifeSciences Corp., Plainsboro, NJ). The device received U.S. Food and Drug Administration (FDA) 510(k) marketing clearance in 1996 because it was substantially equivalent to products on the market prior to device regulation. The implant is described as an “internal orthotic” designed for correction of pediatric pes valgus and adult posterior tibial dysfunction deformity. According to the FDA summary, the primary indication for the subtalar MBA device is “as a spacer for stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.” The implant consists of a soft-threaded titanium device that is inserted into the sinus tarsi and does not require bone cement. The aim of the procedure is to restore the arch by blocking the anterior and inferior displacement of the talus and by preventing the foot from pronating, thus allowing normal subtalar joint motion. Tissue grows normally around the implant and aids in holding it in place. The individual can ambulate the day after surgery in a Cam walker for approximately 3 weeks. Thereafter, regular shoes can be worn with an ankle brace for an additional 2 to 3 weeks. In children, insertion of the MBA implant is frequently offered as a stand-alone procedure, while adults often require adjunctive surgical procedures on bone and soft tissue to correct additional deformities. The MBA Resorb Implant received 510(k) marketing clearance in 2005. This implant employs the same basic mechanical features as the predicate MBA implant, but is composed of a material (poly l-lactic acid) that is reabsorbed by the body.

Incongruence of the talotarsal joint, whether flexible or rigid, is present in pes planovalgus; however, talotarsal dislocation can occur without a flatfoot. The displacement of the talus on the hindfoot bones serves as the apex of the deformity. When conservative care fails, talotarsal stabilization with an extraosseous subtalar joint implant has been proposed as a minimally invasive surgical option to facilitate the natural motion of the joint by placement of the talotarsal fixation device deeply into the sinus tarsi. The extraosseous joint implant differs from a subtalar arthroereisis device, the latter which is an anterior extension of the lateral process for talotarsal stabilization. In 2004, Graham Medical Technologies received 510(k) marketing clearance for the HyProCure Subtalar Implant System/Extra Osseos Fixation Device for treatment of hyperpronated feet.

Definitions

Acquired flatfoot: Flatfoot occurring as a result of fracture or dislocation, tendon disruption, tarsal ligament disruption, tarsal coalition, arthritis, neuroarthropathy, neurologic weakness, or other causes.

Arthroereisis: The limitation of movement across a joint; also referred to as arthroisis.

Calcaneus: The heel bone.

Flexible flatfoot: A complex genetic or environmentally influenced condition where the medial longitudinal arch of the foot lowers and flattens out upon standing but reappears on toe rise.

Pes planus: A complex genetic or environmentally influenced condition with the common characteristic of partial or total flattening of the arch or instep of the foot; also referred to as flatfoot, fallen arches, pes planovalgus, over-pronation or pronation of feet.

Posterior tibial tendon dysfunction (PTTD): A progressive, painful collapse of the medial longitudinal arch of the foot as a result of degenerative or inflammatory processes, overstretching, or traumatic injury to the posterior tibial tendon; the most common cause of  adult-acquired flatfoot.

Subtalar joint: Compound joint located below the ankle joint at the meeting point of the talus and the calcaneus.

Talus: One of the foot and ankle bones, located just above the calcaneus.

Tarsus: Also referred to as the ankle. The seven bones (talus, calcaneus, navicular, medial, intermediate and lateral cuneiform, and cuboid) composing the joint between the foot (metatarsus) and leg.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

CPT

 

28899

Unlisted procedure, foot or toes [when specified as subtalar arthroereisis]

0335T

Extra-osseous subtalar joint implant for talotarsal stabilization

 

 

HCPCS

 

S2117

Arthroereisis, subtalar

 

 

ICD-10 Procedure

 

 

0SUH0JZ

Supplement right tarsal joint with synthetic substitute, open approach

0SUH3JZ

Supplement right tarsal joint with synthetic substitute, percutaneous approach

0SUH4JZ

Supplement right tarsal joint with synthetic substitute, percutaneous endoscopic approach

0SUJ0JZ

Supplement left tarsal joint with synthetic substitute, open approach

0SUJ3JZ

Supplement left tarsal joint with synthetic substitute, percutaneous approach

0SUJ4JZ

Supplement left tarsal joint with synthetic substitute, percutaneous endoscopic approach

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Adelman VR, Szczepanski JA, Adelman RP. 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):400-408.
  2. Blitz NM, Stabile RJ, Giorgini RJ, DiDomenico LA. Flexible pediatric and adolescent pes planovalgus: conservative and surgical treatment options. Clin Podiatr Med Surg. 2010; 27(1):59-77.
  3. Brancheau SP, SP, Walker KM, Northcutt DR. An analysis of outcomes after use of the Maxwell-Brancheau arthroereisis implant. J Foot Ankle Surg. 2012; 51(1):3-8.
  4. Bresnahan PJ, Chariton JT, Vedpathak A. Extraosseous talotarsal stabilization using HyProCure®: preliminary clinical outcomes of a prospective case series. J Foot Ankle Surg. 2013; 52(2):195-202.
  5. Caravaggi P, Lullini G, Berti L et a. Functional evaluation of bilateral subtalar arthroereisis for the correction of flexible flatfoot in children: 1-year follow-up. Gait Posture. 2018; 64:152-158.
  6. Chang TJ, Lee J. Subtalar joint arthroereisis in adult-acquired flatfoot and posterior tibial tendon dysfunction. Clin Podiatr Med Surg. 2007; 24(4):687-697.
  7. Chong DY, Macwilliams BA, Hennessey TA et al. Prospective comparison of subtalar arthroereisis with lateral column lengthening for painful flatfeet. J Pediatr Orthop B 2015; 24(4): 345-353.
  8. Cicchinelli LD, Pascual Huerta J, Garcia Carmona FJ, Fernandez Morato D. 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):385-391.
  9. Faldini C, Mazzotti A, Panciera A et al. Patient-perceived outcomes after subtalar arthroereisis with bioabsorbable implants for flexible flatfoot in growing age: a 4-year follow-up study. Eur J Orthop Surg Traumatol. 2018; 28(4):707-712.
  10. Graham ME, Jawrani NT, Chikka A. Extraosseous talotarsal stabilization using HyProCure® in adults: a 5-year retrospective follow-up. J Foot Ankle Surg. 2012a; 51(1):23-29.
  11. Graham ME, Jawrani NT, Chikka A, Rogers RJ. Surgical treatment of hyperpronation using an extraosseous talotarsal stabilization device: radiographic outcomes in 70 adult patients. J Foot Ankle Surg. 2012b; 51(5):548-555.
  12. Kellermann P, Roth S, Gion K, et al. Calcaneo-stop procedure for paediatric flexible flatfoot. Arch Orthop Trauma Surg. 2011; 131(10):1363-1367.
  13. Koning PM, Heesterbeek PJ, de Visser E. Subtalar arthroereisis for pediatric flexible pes planovalgus: fifteen years experience with the cone-shaped implant. J Am Podiatr Med Assoc. 2009; 99(5):447-453.
  14. Lucaccini C, Zambianchi N, Zanotti G. Distal osteotomy of the first metatarsal bone in association with sub-talar arthroereisis, for hallux valgus correction in abnormal pronation syndrome. Chir Organi Mov. 2008; 92(3):145-148.
  15. Maxwell JR, Carro A, Sun C. Use of the Maxwell-Bracheau arthroereisis implant for the correction of posterior tibial tendon dysfunction. Clin Podiatr Med Surg. 1999; 16(3):479-489.
  16. Mendicino SS. Posterior tibial tendon dysfunction. Diagnosis, evaluation, and treatment. Clin Podiatr Med Surg. 2000; 17(10):33-54, vi.
  17. 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. 2011; 32(12):1127-1139.
  18. Needleman RL. A surgical approach for flexible flatfeet in adults including a subtalar arthroereisis with the MBA sinus tarsi implant. Foot Ankle Int. 2006; 27(1):9-18.
  19. Needleman RL. Current topic review: subtalar arthroereisis for the correction of flexible flatfoot. Foot Ankle Int. 2005; 26(4):336-346.
  20. Nelson SC, Haycock DM, Little ER. Flexible flatfoot treatment with arthroereisis: radiographic improvement and child health survey analysis. J Foot Ankle Surg. 2004; 43(3):144-155.
  21. Ozan F, Dogar F, Gencer K, et al. Symptomatic flexible flatfoot in adults: subtalar arthroereisis. Ther Clin Risk Manag. 2015; 11:1597-1602.
  22. Sanchez AA, Rathjen KE, Mubarak SJ. Subtalar staple arthroereisis for planovalgus foot deformity in children with neuromuscular disease. J Pediatr Orthop. 1999; 19(1):34-38.
  23. Saxena A, Nguyen A. Preliminary radiographic findings and sizing implications on patients undergoing bioabsorbable subtalar arthroereisis. J Foot Ankle Surg. 2007; 46(3):175-180.
  24. Scharer BM, Black BE, Sockrider N. Treatment of painful pediatric flatfoot with Maxwell-Brancheau subtalar arthroereisis implant a retrospective radiographic review. Foot Ankle Spec. 2010; 3(2):67-72.
  25. Smith PA, Millar EA, Sullivan RC. Sta-Peg arthroereisis for treatment of the planovalgus foot in cerebral palsy. Clin Podiatr Med Surg. 2000; 17(3):459-469.
  26. Walley KC, Greene G, Hallam J et al. Short- to Mid-Term Outcomes Following the Use of an Arthroereisis Implant as an Adjunct for Correction of Flexible, Acquired Flatfoot Deformity in Adults. Foot Ankle Spec. 2018 Apr 1. Epub ahead of print.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Evans AM, Rome K. A Cochrane review of the evidence for non-surgical interventions for flexible pediatric flat feet. Eur J Phys Rehabil Med. 2011; 47(1):69-89.
  2. 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. 2004; 43(6):341-373.
  3. 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. 2005; 44(2):78-113.
Websites for Additional Information
  1. American Academy of Orthopaedic Surgeons (AAOS). OrthoInfo. Diseases & Conditions. Available at: http://orthoinfo.aaos.org/menus/diseases.cfm. Accessed on July 18, 2018.
Index

Angled Subtalar Implant (ASI)
Arthrex ProStop and Prostop Plus™ Subtalar Implant
Bioarch® Subtalar Arthroereisis Implant
bioBLOCK® Resorbable Subtalar Implant
BiPro® Horizon Subtalar Implant
Conical Subtalar Implant (CSI)
Disco Subtalar Implant
Extraosseous Talotarsal Stabilization (EOTTS)
Futura™ Angled Subtalar Implant
Futura™ Conical Subtalar Implant
HyProCure Subtalar Implant System
IFS Subtalar Implant
Instratek™ Sub‐Talar Lok™ Arthroereisis Implant System
Kalix II
Life Spine Subtalar Implant System
Lundeen Subtalar Implant (L.S.I.)
Maxwell-Brancheau Arthroereisis (MBA) Implant
MBA Resorb Implant
MC-Subtalar™ II
MetaSurg BioArch Subtalar Implant System
Nexa Orthopedics Subtalar Peg
Normed Vario Subtalar Screw
OsteoMed Talar-Fit™ Subtalar Implant System
OsteoSpring FootJack™ Subtalar Implant System
Smith Subtalar Arthroereisis Implant
STA-Peg
SubFix™ Arthroereisis Implant
Sub-Talar Lok™ Arthroereisis Implant System
Subtalar MBA Implant System
Talar-Fit Subtalar Arthroereisis Implant System
Talus of Vilex (TOV) Subtalar Implants
Trilliant Twist Subtalar Implant

The use of specific product names is illustrative 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.

Document History

Status

Date

Action

Reviewed

09/13/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Rationale, Background/Overview, Definitions and References sections.

Revised

11/02/2017

MPTAC review. The document header wording updated from “Current Effective Date” to “Publish Date.” Removed abbreviation from Position Statement section. Updated Rationale, Background, References, Websites for Additional Information, and Index sections.

Reviewed

11/03/2016

MPTAC review. Updated formatting in Position Statement section. Updated Rationale, References, Websites for Additional Information and Index sections.

Reviewed

11/05/2015

MPTAC review. Updated References sections. Removed ICD-9 codes from Coding section.

Reviewed

11/13/2014

MPTAC review. Updated Description, References, Websites for Additional Information, and Index sections. Minor format changes throughout document.

Revised

11/14/2013

MPTAC review. Revised document Subject and Description. Added investigational and not medically necessary statement for extraosseous subtalar joint implantation. Updated Rationale, Background, Definitions, References, Websites for Additional Information, and Index sections. Updated Coding section with 01/01/2014 CPT changes.

Reviewed

05/09/2013

MPTAC review. Minor format changes. Updated Background, References, and Websites.

Reviewed

05/10/2012

MPTAC review. Updated Rationale, Definitions, and References.

Revised

02/16/2012

MPTAC review. Combined investigational and not medically necessary statements into a single statement. Updated Rationale, Background, References, Websites for Additional Information and Index.

Reviewed

08/18/2011

MPTAC review. Updated References and Index.

Reviewed

08/19/2010

MPTAC review. Updated Rationale, Background, Coding, and References. Added Websites for Additional Information.

Reviewed

08/27/2009

MPTAC review. Updated Rationale, Background, References, and Index.

New

08/28/2008

MPTAC review. Initial document development.