James W. Brodsky

Comparison of Custom and Prefabricated Orthoses in the Initial Treatment of Proximal Plantar Fasciitis

Fifteen centers for orthopaedic treatment of the foot and ankle participated in a prospective randomized trial to compare several nonoperative treatments for proximal plantar fasciitis (heel pain syndrome). Included were 236 patients (160 women and 76 men) who were 16 years of age or older. Most reported duration of symptoms of 6 months or less. Patients with systemic disease, significant musculoskeletal complaints, sciatica, or local nerve entrapment were excluded. We randomized patients prospectively into five different treatment groups. All groups performed Achilles tendon- and plantar fascia-stretching in a similar manner. One group was treated with stretching only. The other four groups stretched and used one of four different shoe inserts, including a silicone heel pad, a felt pad, a rubber heel cup, or a custom-made polypropylene orthotic device. Patients were reevaluated after 8 weeks of treatment. The percentages improved in each group were: (1) silicone insert, 95%; (2) rubber insert, 88%; (3) felt insert, 81%; (4)stretching only, 72%; and (5) custom orthosis, 68%. Combining all the patients who used a prefabricated insert, we found that their improvement rates were higher than those assigned to stretching only (P = 0.022) and those who stretched and used a custom orthosis (P = 0.0074). We conclude that, when used in conjunction with a stretching program, a prefabricated shoe insert is more likely to produce improvement in symp-toms as part of the initial treatment of proximal plantar fasciitis than a custom polypropylene orthotic device.

Prospective Controlled Trial of STAR Total Ankle Replacement versus Ankle Fusion: Initial Results

Background: Mobile-bearing ankle replacements have become popular outside of the United States over the past two decades. The goal of the present study was to perform a prospective evaluation of the safety and efficacy of a mobile-bearing prosthesis to treat end stage ankle arthritis. We report the results of three separate cohorts of patients: a group of Scandanavian Total Ankle Replacement (STAR) patients and a control group of ankle fusion patients (the Pivotal Study Groups) and another group of STAR total ankle patients (Continued Access Group) whose surgery was performed following the completion of enrollment in the Pivotal Study. Materials and Methods: The Pivotal Study design was a non-inferiority study using ankle fusion as the control. A non-randomized multi-centered design with concurrent fusion controls was used. We report the initial perioperative findings up to 24 months following surgery. For an individual patient to be considered an overall success, all of the following criteria needed to be met: a) a 40-point improvement in total Buechel-Pappas ankle score, b) no device failures, revisions, or removals, c) radiographic success, and d) no major complications. In the Pivotal Study (9/00 to 12/01), 158 ankle replacement and 66 arthrodesis procedures were performed; in the Continued Access Study (4/02 to 10/06), 448 ankle replacements were performed, of which 416 were at minimum 24 months post-surgery at time of the database closure. Results: Major complications and need for secondary surgical intervention were more common in the Pivotal Study arthroplasty group than the Pivotal Study ankle fusion group. In the Continued Access Group, secondary procedures performed on these arthroplasty patients decreased by half when compared with the Pivotal Arthroplasty Group. When the Pivotal Groups were compared, treatment efficacy was higher for the ankle replacement group due to improvement in functional scores. Pain relief was equivalent between fusion and replacement patients. The hypothesis of non-inferiority of ankle replacement was met for overall patient success. Conclusion: By 24 months, ankles treated with STAR ankle replacement (in both the Pivotal and Continued Access Groups) had better function and equivalent pain relief as ankles treated with fusion. Level of Evidence: II, Prospective Controlled Comparative Surgical Trial

First Metatarsophalangeal Arthrodesis: A Clinical, Pedobarographic and Gait Analysis Study

This study investigated the results of first metatarsophalangeal (MTP) arthrodesis in terms of clinical outcome measures, plantar pressure distribution, and gait patterns. Ten feet in nine patients with severe hallux rigidus (HR) who underwent first MTP arthrodesis were studied. The preoperative evaluation included a subjective questionnaire, physical exam, AOFAS hallux score, radiographs and dynamic pedobarography (EMED). At follow-up (average 34 months) these were repeated, and gait analysis studies were obtained. Patients showed significant clinical improvement based on the subjective criteria. The mean AOFAS score improved from 38 preoperatively to 90 postoperatively. Postoperative EMED analysis showed restoration of the weightbearing function of the first ray, with greater maximum force carried by the distal hallux at toe-off. Kinematic and kinetic gait analysis from each patients operative limb were compared to the unaffected contralateral limb and to age- and sex-matched healthy subjects. The kinematic data indicated a significantly shorter step length with some loss in ankle plantar flexion at toe-off on the fused side. The kinetic data indicated a reduction in both ankle torque and ankle power at push-off. Clinical results indicated effective pain relief and a high level of patient satisfaction, consistent with previous reports in patients with symptomatic Hallux Rigidus.

Exostectomy for Symptomatic Bony Prominences in Diabetic Charcot Feet

Exostectomy for plantar ulceration is demonstrated to be a satisfactory procedure and one with significantly less morbidity and quicker healing than a more major reconstructive procedure such as arthrodesis. The predominance of Type I (midfoot breakdown) confirms reports on the natural history of the diabetic Charcot tarsus; the midfoot has a tendency to develop symptomatic bony prominences.

Prospective gait analysis in patients with first metatarsophalangeal joint arthrodesis for hallux rigidus.

Background: Arthrodesis of the first metatarsophalangeal (MTP) joint is a common procedure with a proven long-term success rate. However, there is limited scientific information on its functional results. There is little data in the literature about changes in gait parameters after first MTP joint arthrodesis. The purpose of this study was to objectively evaluate the effects of first MTP joint arthrodesis on gait. Methods: Twenty-three patients with symptomatic hallux rigidus refractory to nonoperative treatment were treated with first MTP joint arthrodesis. A prospective gait analysis study was performed on all patients at an average of 8.6 days before surgery and then again at least 1 year postoperatively. Preoperative and postoperative data from the patients were compared to determine differences in clinically relevant temporal-spatial, kinematic, and kinetic parameters of gait. Results: There were three statistically significant changes in gait: increases in maximal ankle push-off power and single-limb support time on the involved extremity, and a decrease in step width. Conclusions: First MTP joint arthrodesis produces objective improvement in propulsive power, weightbearing function of the foot, and stability during gait.

Clinical results of harvesting autogenous cancellous graft from the ipsilateral proximal tibia for use in foot and ankle surgery.

Introduction: The harvesting of autogenous cancellous bone graft has many uses in foot and ankle surgery. The most common referenced donor sites are the iliac crest, distal tibia, and calcaneus. These all have demonstrated limitations, the high morbidity rate associated with the iliac crest and the poor quantity of graft from distal sources. Materials and Methods: Between April 1995 and February 2000, 155 patients were retrospectively indentified who had undergone a foot or ankle procedure utilizing the ipsilateral, proximal tibia as the donor site for autogenous cancellous graft. The patients were 18 years or older with no history of previous bony surgery to the tibia used and no history of previous injury or pain in the knee. The group included patients with isolated reconstructions as well as multiextremity trauma patients. All were kept nonweightbearing on the involved extremity for a minimum of 6 weeks postoperatively. Results: There were 90 male and 65 female patients. The average age was 41 years and 5 months. There were 51 smokers averaging 17.6 pack years (range, 1-50 pack years). Twenty-six patients were admitted alcoholics, and 12 admitted to prior intravenous drug use. Cancellous graft was utilized in both traumatic and reconstructive settings. Eighty-nine fractures in 86 patients received grafting. Sixty-nine reconstructions or fusions of the hindfoot or midfoot were done using this technique. There were no reported major complications due to this procedure. No fractures, infections, or wound breakdowns occurred during this study. There were no reported long-term problems with knee pain or function. There was one postoperative hematoma that resolved over time. There were three incidents of sensory changes at the incision site. Conclusion: The use of the ipsilateral proximal tibia as a source for autogenous cancellous bone graft is a procedure with low added morbidity and a source of adequate graft material.

Psychometric Comparison of the PROMIS Physical Function CAT With the FAAM and FFI for Measuring Patient-Reported Outcomes

Background: Selecting optimal patient-reported outcome (PRO) instruments is critical to improving the quality of health care. The purpose of this study was to compare the reliability, responsiveness, and efficiency of three PRO measures: the Foot and Ankle Ability Measure–Activity of Daily Living subscale (FAAM_ADL), the Foot Function Index 5-point verbal rating scale (FFI-5pt), and the PROMIS Physical Function computerized adaptive test (PF CAT). Methods: Data were aggregated from 10 clinical sites in the AOFAS’s National Orthopaedic Foot and Ankle Research (OFAR) Network from 311 patients who underwent elective surgery for a disorder of the foot or ankle. Patients were administered the FAAM_ADL, FFI-5pt, and PF CAT at their preoperative visit and at 6 months after surgery. Reliabilities were evaluated using a Rasch model. Responsiveness was calculated using paired samples t test and efficiency was recorded as number of seconds to complete the instrument. Results: Similar reliabilities were found for the three instruments. Item reliabilities for FAAM_ADL, FFI-5pt, and PF CAT were all .99. Pearson reliabilities for FAAM_ADL, FFI-5pt, and PF CAT were .95, .93, and .96, respectively. On average, patients completed the FAAM_ADL in 179 seconds, the FFI-5pt in 194 seconds, and the PF CAT in 44 seconds, (P < .001). The PF CAT and FAAM_ADL showed significant improvement (P = .01 and P = .001, respectively) in patients’ physical function after treatment; the FFI-5pt did not show improvement. Conclusions: Overall, the PF CAT performed best in terms of reliability, responsiveness, and efficiency in this broad sample of foot and ankle patients. It can be a potential replacement for the conventional PRO measures, but further validation is needed in conjunction with the PROMIS Pain instruments. Level of Evidence: Level I, prospective comparative outcome study.

Surgery for hallux valgus with proximal crescentic osteotomy causes variable postoperative pressure patterns.

We prospectively evaluated the results of plantar pressure measurement in 32 patients (43 feet) who had a proximal crescentic osteotomy of the first metatarsal with a modified McBride procedure. The procedures effectiveness in increasing weightbearing under the first ray, decreasing pressure under the second metatarsal head, and the relationship of radiographic measurements of first metatarsal length and position to postoperative pressure measurements were evaluated. Mean followup was 29 months. Average peak pressure increased postoperatively under the second metatarsal head. Almost identical numbers of feet had first metatarsal elevation (12) or depression (11) greater than 2 mm. Radiographic evidence of first metatarsal elevation, but not shortening, was associated with diminishing peak pressure and pressure-time integral under the first metatarsal head and hallux. Five feet that had first metatarsal elevation greater than 2 mm had new second metatarsal transfer lesions develop. Eleven feet preoperatively and nine feet postoperatively had symptomatic second metatarsal pressure lesions. One lesion persisted, 10 resolved, and eight new lesions developed. Control of the crescentic osteotomy in the sagittal plane was unpredictable despite modification of the surgical technique to plantarly displace the distal segment of the first meta-tarsal. Although average second metatarsal pressure increased postoperatively, there was variability in the correlation of radiographic change and pedobarographic measurements.

The Orthopaedic Foot and Ankle Outcomes Research (OFAR) network: feasibility of a multicenter network for patient outcomes assessment in foot and ankle.

Introduction: There is an increasing need for orthopaedic practitioners to measure and collect patient-reported outcomes data. In an effort to better understand outcomes from operative treatment, the American Orthopaedic Foot & Ankle Society (AOFAS) established the Orthopaedic Foot and Ankle Outcomes Research (OFAR) Network, a national consortium of foot and ankle orthopaedic surgeons. We hypothesized that the OFAR Network could successfully collect, aggregate, and report patient-reported outcome (PRO) data using the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS). Methods: Ten sites enrolled consecutive patients undergoing elective surgery for 1 of 6 foot/ankle disorders. Outcome instruments were collected preoperatively and at 6 months postoperatively using the PROMIS online system: Foot and Ankle Ability Measure (FAAM), Foot Function Index (FFI), and PROMIS physical function (PF) and pain computerized adaptive tests (CAT). During the 3-month period, 328 patients were enrolled; 249 (76%) had completed preoperative patient-reported outcomes data and procedure-specific data. Of these, 140 (56%) also completed 6-month postoperative patient- reported outcomes data. Results: Ankle arthritis and flatfoot demonstrated consistently worse preoperative scores. Five of 6 disorders showed significant improvement at 6 months on PF CAT and FAAM, 4 of 6 showed improvement on pain interference CAT, and no disorders showed improvement on FFI. Ankle arthritis and flatfoot demonstrated the greatest magnitude of change on most patient-reported outcomes scales. Conclusion: We were able to enroll large numbers of patients in a short enrollment period for this preliminary study. Data were easily aggregated and analyzed. Substantial loss of follow-up data indicates a critical area requiring further effort. The AOFAS OFAR Network is undergoing expansion with goals to ultimately facilitate large, prospective multicenter studies and optimize the quality and interpretation of available outcome instruments for the foot and ankle population. Level of Evidence: Level II, prospective comparative study.

Plantar Pressures in Fiberglass Total Contact Casts vs. a New Diabetic Walking Boot

The objective of this study was to determine in healthy individuals whether the Bledsoe Diabetic Conformer Boot reduces plantar pressures as well as a fiberglass total contact cast. Eighteen normal subjects, without any prior foot or ankle problems, were recruited for this study. Plantar pressures were measured using the Novel Pedar™ in-shoe pressure measurement system. The results of this study demonstrate that in individuals without foot deformities, the Bledsoe Diabetic Conformer Boot™ performs as well as, and in many parameters, even better than a fiberglass total contact cast with respect to reducing the forces and pressures on the plantar surface of the foot.