Department of Veterans Affairs Journal of Rehabilitation Research and Development Vol . 33 No. 1, February 1996 Pages 16-22 Use of bivalved ankle-foot orthosis in neuropathic foot and ankle lesions Michael L. Boninger, MD and James A . Leonard, Jr ., MD Division of Physical Medicine and Rehabilitation, Department of Orthopaedic Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA 15213; Department of Physical Medicine and Rehabilitation, University of Michigan Medical Center, Ann Arbor, MI 48109 AbstractThe neuropathic foot is a common complication diabetes mellitus (1) . Diabetes mellitus leads to periph- of diabetes mellitus and is associated with development of eral neuropathy in up to 50 percent of patients . This chronic ulcers and Charcot joints . Treatment of these neuropathy can lead to skin ulcerations, arthropathy, complications presents a complex management task . This and eventually amputation (2–4) . To halt the progres- report presents long-term follow-up data on 16 patients with sion from arthropathy and ulceration to amputation, neuropathic changes who were treated with a total contact, effective treatment is essential. laminated, bivalved, rocker-bottom-soled ankle-foot orthosis (TCAFO). Of the 16 patients, 6 were treated for Charcot In the initial stages, neuropathic arthropathy is changes only, 10 were treated for ulcers, and 2 of the 10 had treated with cessation of weight bearing, immobiliza- ulcers bilaterally . Eight of the 12 ulcers (67%) healed in an tion, and elevation of the edematous foot (4). As average of 10 months (range 1-24 mo), 1 patient required improvement is seen, patients may begin to ambulate amputation, and 2 patients with unhealed ulcers are still in with crutches, and eventually a walking cast can be TCAFOs. Of the 7 patients who had complete healing, 5 have applied. Immobilization is usually needed for a mini- resumed wearing TCAFOs secondary to recurrent ulcers. mum of 8 to 12 weeks (5,6) ; however, longer times are Three of the 5 patients with Charcot changes no longer use not uncommon. Return to full ambulation without a cast the orthosis and have had negative bone scans after an commonly takes 4 to 5 months (4) and special footwear average of 20.7 months (range 12-28 mo). In this retrospec- is needed to prevent refracture . Walking casts must be tive uncontrolled study, the TCAFO proved to be a safe, applied with extreme care to assure that no ulcerations functional, and cost-effective therapy for complications of the occur underneath the cast. neuropathic foot. Treatment of neuropathic ulcerations requires re- Key words: Charcot joint, diabetic neuropathy, foot ulcer, moval of surrounding callus, eradication of infection, healing, neurogenic arthropathy, orthosis. and reduction of forces. The most commonly used methods to reduce forces on the ulcer, and thus promote healing, are bed rest, non-weight bearing or crutch INTRODUCTION ambulation, special footwear (7-10), and total-contact casting (TCC) (9,11–15) . TCC has proven to be very Each year, in excess of half a billion dollars is effective in promoting healing, with complete ulcer spent in the United States on amputations secondary to healing in as short as 1 to 2 months (11–13,16). Although the above treatments are effective, prob- Address all correspondence and requests for reprints to : Michael L . Boninger, lems still exist. Patient compliance with bed rest is MD, University of Pittsburgh Medical Center, Division of Physical Medicine notoriously poor (17) . When patients do stay at bed rest, and Rehabilitation, 901 Kaufmann Building, 3471 Fifth Avenue, Pittsburgh, PA 15213-3221 . deconditioning and its multiple medical sequelae result 16 17 BONINGER and LEONARD: Bivalved Ankle-Foot Orthosis (18). Although ambulation is possible with TCC, this callus, as well as bony prominences . During casting, the treatment should not be used until after the infection has foot was placed in as anatomically neutral a position as cleared (1). The casts require frequent changing, espe- possible . The TCAFO was then made with either a cially as swelling decreases, and there is risk of ulcer vacuum-formed thermoplastic material or a vacuum- development underneath the cast in the insensate foot. formed thermosetting resin reinforced with carbon fiber. Because of the perceived risk of ulceration, many In both cases, the anterior and posterior shells were physicians and patients are hesitant to use this form of made in separate pullings . The shell was lined with a treatment. dense pelite inner shell which allows for adjustments This paper describes the long-term experience with and changes over time . A rocker sole and Velcro ® use of a rigid, removable, total contact, laminated, straps were added to produce the final product (Figure rocker-bottomed ankle-foot orthosis (TCAFO). 1). Over the past few years, acrylic resin has been used exclusively because it is lighter and stronger, and it can be colored. METHODS The review board at the institution approved the RESULTS study. The study design is a retrospective series without a comparison cohort. The initial TCAFO was con- Subjects structed in 1984 to provide an alternative treatment for Of the 16 patients located through a review of the patients with neuropathic ulcerations or arthropathy. orthotics and prosthetics clinic records, one was lost to Following good experience with the initial patient, all follow-up prior to healing ; two patients, who had patients who met the following clinical criteria were complete healing, could not be located; and one patient, offered the orthosis as a treatment option : 1) ulcer who was unable to return for a clinic visit, completed a present for at least 6 months ; 2) other types of telephone interview . The remaining 12 patients com- treatment, including footwear modification, attempted pleted all aspects of the study . Although little informa- without success ; and 3) amputation recommended by a tion is available on the patient who was lost to surgeon if clinical improvement could not be seen. In follow-up, she was included in the results to provide a addition, individuals with newly diagnosed neuropathic complete picture of our experience with the orthosis. arthropathy documented by a positive bone scan were The average age of the patients was 53 .4 years offered the TCAFO. The need for compliance with the (range 37 to 67) . There were 6 females and 10 males use of the orthosis was emphasized to all patients. (see Table 1 for subject characteristics) . The most All patients treated with a TCAFO were located common cause of neuropathy was diabetes mellitus through review of the outpatient orthotics and prosthet- which was present in 12 of the patients . Patient 11 had ics clinic files . The criteria for inclusion in the study concomitant chronic renal failure and 3 patients were was that the patient received the TCAFO 6 months prior diagnosed as having peripheral vascular occlusive to the beginning of the chart review . For all patients, disease. Two patients had a peripheral neuropathy of information was obtained from a thorough review of the unknown etiology and patient 13 had bilateral Charcot- medical record. On completion of the review, patients like joints without neuropathy. were asked to attend a follow-up visit . During the follow-up visit, the patient's neuropathy and limb Charcot Joint Treatment condition were documented with a neurologic and Six patients were treated for Charcot changes only musculoskeletal exam. In addition, data collected during (see Table 2). Of these 6 patients, 2 had arthropathy of the chart review were verified and patients were both feet resulting in a total of 8 feet being treated for surveyed by a standard questionnaire . Those patients Charcot changes' only . Three patients discontinued who could not attend a clinic visit were telephoned and wearing the TCAFO after an average of 20 .7 months asked the same set of questions. (range 12 to 28) . The decision to discontinue TCAFO Each TCAFO was constructed by taking a cast of use was based on a previously abnormal bone scan the affected extremity and making a positive mold from returning to normal. One patient (No. 13) has worn the the cast. The positive mold was then modified to TCAFO for 45 months for pain prevention and plans to provide pressure relief over areas of ulceration and continue to use the orthosis . 18 Journal of Rehabilitation Research and Development Vol .33 No . 1 1996 (a) (b) Figure 1. The total contact, laminated, bivalved, rocker-bottom soled ankle-foot orthosis (TCAFO), (a) open and (b) closed. Ulcer Treatment new ulceration developed over a short period of time. Ten patients were treated for ulcers (see Table 3). This ulceration later completely healed . The most Two Patients (8 and 10) had ulcers present on both feet, common complications reported were areas of skin giving a total of 12 ulcers. Of the 12 feet with ulcers, 8 redness and orthotic failure . The most common orthotic had documented Charcot changes . The time to initial failure was broken straps . In each instance, all that was healing is recorded for each patient; if the ulcer never required was a return visit to the orthotist . From the healed, the total time in the orthosis is listed . Of the 12 patient report, the TCAFO lasted between 1 and 2 years; ulcers, 8 healed in an average of 10 months (range 1 to the most common causes for replacement were general- 24). Patient 10 was lost for follow-up prior to healing ized wear, a cracked outer shell, or changes in the and was reported in the chart as being noncompliant. patients' feet (see Table 4). The most common required Patient 2 reported near-complete healing of the ulcer; modification was pressure relief over a reddened area. however, because osteomyelitis was not responsive to antibiotics, the patient underwent an amputation . Patient Questionnaire Results 6 never had complete healing despite being in the Thirteen of the 16 patients completed the survey TCAFO for 66 months .