Follow-up Evaluation of Medial Clear Space and Talar Tilt After Bimalleolar Equivalent Fracture Fixation Without Primary Deltoid Repair.

BACKGROUND: We sought first to determine the efficacy of lateral ankle fixation alone in maintenance of medial clear space and talar valgus in bimalleolar equivalent ankle fractures not receiving primary deltoid repair, and second to assess perceived outcomes via the Foot and Ankle Outcome Score. To our knowledge, no study has quantified the reduction of medial clear space and talar valgus in bimalleolar equivalent ankle fractures receiving lateral ankle fixation alone. METHODS: We compared preoperative, initial postoperative, and greater than 1-year follow-up radiographs of medial clear space and talar valgus in individuals who received lateral ankle fixation alone in bimalleolar equivalent ankle fractures. Subjective outcomes were measured via the Foot and Ankle Outcome Score. RESULTS: Thirty-seven patients participated in the study and showed a statistically significant reduction of medial clear space and restoration of talar position, and maintenance with this fixation method during follow-up in patients with bimalleolar equivalent ankle fractures. Adjunctively, patients perceived their outcomes to be satisfactory, as demonstrated by the results of the Foot and Ankle Outcome Score. CONCLUSIONS: We aimed to assess the efficacy of lateral ankle fixation in the maintenance of medial clear space and talar valgus reduction at midterm follow-up. Although some authors contend that primary deltoid repair in bimalleolar equivalent ankle fractures is warranted, these midterm study results suggest that isolated lateral ankle fixation is adequate for medial ankle stabilization in bimalleolar equivalent fractures, and thus primary deltoid repair is not indicated.

Novel Investigation of the Deep Band of the Lateral Plantar Aponeurosis and Its Relationship With the Lateral Plantar Nerve.

BACKGROUND: We describe a thick fascial band arising from the medial aspect of the lateral plantar aponeurosis diving deep into the forefoot crossing over a branch of the lateral plantar nerve. Because a review of current literature resulted in limited and outdated sources, we sought to first determine the frequency of this fascial band and the location where it crosses the lateral plantar nerve and, second, discuss the clinical applications these anatomical findings could have. METHODS: 50 pairs of cadaveric feet (n = 100) were dissected to investigate for presence of the fascial band and its interaction with the lateral plantar nerve. Images were taken of each foot with the fascial band. ImageJ was used to take 2 measurements assessing the relationship of the tuberosity of the base of the fifth metatarsal to where the nerve crossed deep to the fascial band. RESULTS: Overall, 38% of the feet possessed the fascial band. It was found unilaterally in 10 pairs and bilaterally in 14 pairs. On average, the point at which the lateral plantar nerve passed deep to the fascial band was 2.0 cm medial and 1.7 cm anterior to the tuberosity of the base of the fifth metatarsal. CONCLUSION: When present, the deep band of the lateral plantar aponeurosis (PA) was consistently found to be crossing the lateral plantar nerve. The discovery of the location where this most commonly occurs has not been previously reported and adds an interesting dimension that elevates an anatomical study to one that has clinical potential. CLINICAL RELEVANCE: The established target zone gives a precise location for where the relationship between the deep band of the lateral PA and the lateral plantar nerve exists when evaluating the foot. The target zone provides a potential springboard for future investigations concerning said relationship clinically.

Clinical Outcomes for Diabetic Foot Ulcers Treated with Clostridial Collagenase Ointment or with a Product Containing Silver.

Objective: To compare outcomes of diabetic foot ulcers (DFUs) treated with clostridial collagenase ointment (CCO) or silver-containing products, both in combination with sharp debridement as needed. Approach: One hundred two subjects with qualifying DFUs were randomized to daily treatment with either CCO or a silver-containing product for 6 weeks followed by a 4 -week follow-up period. The primary outcome was the mean percent reduction in DFU area. A secondary outcome was the incidence of ulcer infections between groups. Results: At the end of treatment, the mean percent reduction in area from baseline of DFUs treated with CCO was 62% (p < 0.0001) and with silver was 40% (p < 0.0001). The difference between groups-22%-was not statistically significant (p = 0.071). Among ulcers closed by the end of treatment, the mean time to closure was 31.1 ± 9.0 days versus 37.1 ± 7.7 days, respectively (not statistically significant). There was a numerically greater incidence of target ulcer infections in the silver group (11, 21.6%) than in the CCO group (5, 9.8%; p = 0.208). No clinically relevant safety signals were identified in either group. Innovation: CCO treatment can progress a wound toward closure. Ulcer infection prophylaxis may not be sacrificed when treating DFU with CCO in lieu of silver-containing products. Conclusion: Both CCO and silver-containing products promote significant reduction in DFU area over 6 weeks of treatment with no clinically relevant safety concerns. Mean percent reduction in lesion area was numerically (22%) but not significantly greater with CCO compared to silver, as was time to ulcer closure, with an incidence of ulcer infection at least as low as for silver-containing products.

Erratum to: Cost-effectiveness of clostridial collagenase ointment on wound closure in patients with diabetic foot ulcers: economic analysis of results from a multicenter, randomized, open-label trial.

[This corrects the article DOI: 10.1186/s13047-015-0065-x.].

Comparing the Knotless Tension Band and the Traditional Stainless Steel Wire Tension Band Fixation for Medial Malleolus Fractures: A Retrospective Clinical Study.

The traditional stainless steel wire tension band (WTB) has been popularized for small avulsion fractures at the medial malleolus. Despite the tension band principle creating a stable construct, complications continue to arise utilizing the traditional stainless steel WTB with patients experiencing hardware irritation at the tension band site and subsequent hardware removal. Coupled with hardware irritation is fatigue failure with the wire. The goal of this investigation was to retrospectively compare this traditional wire technique to an innovative knotless tension band (KTB) technique in order to decrease costly complications. A total of 107 patients were reviewed with a minimum follow-up of 1 year. Outcome measures include descriptive data, fracture classification, results through economic costs, and fixation results (including hardware status, healing status, pain status, and time to healing). The KTB group had a 13% lower true cost as compared to the WTB group while the fixation results were equivocal for the measured outcomes. Our results demonstrate that the innovative KTB is comparable to the traditional WTB while offering a lower true cost, an irritation free reduction all without the frustration of returning to the operating room for additional hardware removal, which averages approximately to $8,288.

Cost-Effectiveness of Becaplermin Gel on Diabetic Foot Ulcer HealingChanges in Wound Surface Area.

BACKGROUND: A comparison of the cost-effectiveness of becaplermin plus good wound care (BGWC) versus good wound care (GWC) alone in treating patients with diabetic foot ulcers (DFUs) may enable physicians and health-care decision makers in the United States to make better-informed choices about treating DFUs, which currently contribute to a substantial portion of the economic burden of diabetes. METHODS: Data from three phase III trials were used to predict expected 1-year costs and outcomes, including the average percentage reduction from baseline in wound surface area (WSA), the direct costs of DFU therapy, and the cost per cm(2) of WSA reduction. RESULTS: At 20 weeks, the BGWC group had a statistically greater probability of complete wound closure than the GWC group (50% versus 35%; P = .015). Based on reported WSA reduction rates, DFUs in the BGWC group were predicted to close by 100% at 27 weeks, and those in the GWC group were predicted to close by 88% at 52 weeks. The GWC group had higher total estimated 1-year direct cost of DFU care ($6,809 versus $4,414) and higher cost per cm(2) of wound closure ($3,501 versus $2,006). CONCLUSIONS: Becaplermin plus good wound care demonstrated economic dominance compared with GWC by providing better clinical outcomes via faster reduction in WSA and higher rates of closure at a lower direct cost.

Cost-effectiveness of becaplermin gel on wound healing of diabetic foot ulcers.

We sought to determine the long-term cost effectiveness (payer's perspective) of becaplermin gel plus good wound care (BGWC) vs. good wound care (GWC) alone in terms of wound healing and risk of amputation in patients with diabetic foot ulcers (DFUs). Outcomes data were derived from a propensity score-matched cohort from the Curative Health Services database between 1998 and 2004, which was followed for 20 weeks. A four-state Markov model was used to predict costs and outcomes of wound healing and risk of amputation for BGWC vs. GWC alone over 1 year in patients with DFU. The primary outcome was closed-wound weeks. Transition probabilities for healing and amputation were derived from the aforementioned propensity score-matched cohorts. Ulcer recurrence was estimated from the medical literature. Utilization for becaplermin was calculated using the dosing algorithm in the product labeling. Of 24,898 eligible patients, 9.6% received BGWC. Based on the model, patients treated with BGWC had substantially more closed-wound weeks compared with GWC (16.1 vs. 12.5 weeks, respectively). More patients receiving BGWC had healed wounds at 1 year compared with those receiving GWC (48.1% vs. 38.3%). Risk of amputation was lower in the BGWC cohort (6.8% vs. 9.8%). Expected annual direct costs for DFU were $21,920 for BGWC and $24,640 for GWC. BGWC was economically dominant over GWC, providing better outcomes at a lower cost in patients with DFU. Compared with GWC alone, BGWC is more effective in healing wounds and lowering amputation risk, thereby decreasing long-term costs for DFU.

Cost-effectiveness of clostridial collagenase ointment on wound closure in patients with diabetic foot ulcers: economic analysis of results from a multicenter, randomized, open-label trial.

BACKGROUND: Approximately 10%-15% of people with diabetes develop at least one foot ulcer during their lifetime. Treatment of diabetic foot ulcers (DFUs) represents a significant economic burden. Enzymatic debridement with clostridial collagenase ointment (CCO) can be used to remove necrotic tissue from wounds. This study examined the impact of CCO as an effective adjunct therapy to serial sharp debridement (SSD) and assessed the cost-effectiveness of CCO compared with standard DFU treatments over 1 year. METHODS: Adults 18 years or older with a diagnosis of type 1 or type 2 diabetes who had a neuropathic DFU were enrolled in a 12-week, randomized, open-label trial. Patients were randomly assigned to either treatment with CCO + SSD or to investigator-selected supportive care + SSD (Control). A 3-state Markov model with a 1-week cycle length was developed using wound-closure rates from the trial to estimate the number of healed-wound weeks and the expected DFU cost per patient. The 3 states included unhealed, healed, and death. Results were extrapolated to 1 year to estimate the number of healed-wound weeks per treatment and the average cost to achieve epithelialization. The perspective of the analysis was that of the payer, specifically, the third party payer. RESULTS: The study sample included 55 patients (28 in CCO group; 27 Control). The majority were men (74.5%) with a mean age of 57.9 years. Projected healing rates were greater for the CCO + SSD group compared to Control (89% vs. 80%, respectively). The expected number of epithelialized weeks accumulated over 1 year was 25% greater in the CCO + SSD group than for Control (35 vs. 28 weeks, respectively). Over a 1-year time horizon, the expected cost per DFU was greater in the Control group than the CCO group ($2,376 vs. $2,099, respectively). The estimated cost per ulcer-free week was 40% higher for Control ($85/closed-wound week) than for CCO + SSD ($61/closed-wound week). CONCLUSIONS: CCO + SSD therapy is a cost-effective method of debridement in the management of patients with DFUs, providing better outcomes at a lower cost. Further high quality trials are needed to confirm this finding. TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov as NCT01408277.

Clinical outcomes associated with serial sharp debridement of diabetic foot ulcers with and without clostridial collagenase ointment.

OBJECTIVE: Fifty-five subjects with diabetes mellitus type 1 or 2 and a neuropathic, nonischemic foot ulcer were enrolled into this randomized, controlled, multicenter trial designed to examine the effects of debridement with clostridial collagenase ointment (CCO) used in conjunction with serial sharp debridement for a period of 6 weeks. METHODS: Serial sharp debridement without adjunctive CCO was used in the control group. Various standard care therapies thought to support debridement by endogenous proteases were selected at the discretion of the investigators for use in the control group. The primary outcome measure of this trial was the percent change in ulcer area from baseline at the end of the debridement/treatment period (EOT) and at the end of an additional 6 weeks of follow-up (EOS). Secondary objectives were to assess wound status at EOT and EOS using a standardized wound assessment tool, and to compare the average time to closure for ulcers debrided with serial sharp debridement with and without adjunctive CCO. RESULTS: Wound area decreased relative to baseline for both the CCO group (-68%, -61%) and the control group (-36%, -46%) at EOT and EOS, respectively. While the inter-group differences did not reach statistical significance, wound area was significantly decreased from baseline at both EOT and EOS for the CCO (P < 0.001) but not for the control group. Wound status scores (scale range 8 to 40) improved for both groups during treatment (CCO: -3.5, control: -3.2) and follow-up (CCO: -5.3, control: -6.4). No differences were observed in the number of sharp debridements (CCO: 3.7, control: 4.0). Median time to closure for wounds that healed was 6 weeks for CCO and 8 weeks for control. On average, ulcers treated with serial sharp debridement plus adjunctive CCO decreased in size more rapidly than ulcers treated without adjunctive CCO debridement. No safety issues were identified based on a review of reported adverse events. CONCLUSION: These results suggest there is more to wound debridement than meets the eye, and establish a foundation for larger, confirmatory studies.

Clinical and economic assessment of diabetic foot ulcer debridement with collagenase: results of a randomized controlled study.

BACKGROUND: Despite significant advances, the treatment of diabetic foot ulcers (DFUs) remains a major therapeutic challenge for clinicians, surgeons, and other health care professionals. There is an urgent need for new strategies with clinically effective interventions to treat DFUs to reduce the burden of care in an efficient and cost-effective way. OBJECTIVE: This randomized trial evaluated and compared the clinical effectiveness, tolerability, and costs of clostridial collagenase ointment (CCO) debridement to that of debridement using saline moistened gauze (SMG) and selective sharp debridement for the treatment of DFUs. METHODS: Randomized, controlled, parallel group, multicenter, open-label, 12-week study of 48 patients with neuropathic DFUs randomized to 4 weeks of treatment with either CCO or SMG after baseline surgical debridement. The primary end point was the condition of the ulcer bed at the end of treatment as measured using a standardized wound assessment tool. Secondary end points were the percentage of reduction in wound area and therapeutic response rates. Adverse events were monitored for the tolerability analysis. In addition, a comparative cost-effectiveness analysis was performed from the perspective of the Centers for Medicare and Medicaid Services as a payer. RESULTS: Both the CCO and SMG groups had significantly improved wound assessment scores after 4 weeks of treatment (CCO, -2.5, P = 0.007; SMG, -3.4, P = 0.006). Only CCO treatment resulted in a statistically significant decrease from baseline in the mean wound area at the end of treatment (P = 0.0164) and at the end of follow-up (P = 0.012). In addition, the CCO group exhibited a significantly better response rate at the end of follow-up compared with the SMG group (0.92 vs 0.75, P < 0.05). Reported adverse events were similar between the 2 treatment groups. None of the reported adverse events were considered to be related to treatment. The economic analysis indicated that the direct mean costs per responder in the physician office setting of care were $832 versus $1042 for the CCO group versus the SMG group, whereas the direct mean costs per responder in the hospital outpatient department setting were $1607 versus $1980. CONCLUSIONS: CCO treatment provides equivalent debridement of DFUs similar to SMG while fostering better progress toward healing as measured by decreasing wound area over time and improved response rates at the end of follow-up. In addition, CCO yields a more favorable cost-effectiveness ratio in both the physician office and hospital outpatient department settings of care. ClinicalTrials.gov identifier: NCT01056198.

Association of hindfoot ligament tears and osteochondral lesions.

BACKGROUND: This study aimed to identify the prevalence of ligament and joint surface anatomy variants, ligament tears, and osteochondral lesions (OCLs) in the hindfoot. These data were used to identify associations between anatomic variants or ligament tears and OCLs. METHODS: Seventy-two cadaver hindfoot specimens were examined. Hindfoot ligament presence, number of ligament fascicles, variable ligament attachment sites, ligament tears, presence of joint facets, variable joint surface shape, and the location and grade of OCLs were identified in each specimen. The data were analyzed for significant associations between variables. RESULTS: Fourteen of the 30 studied ligaments were always present and 14 had variable number of fascicles. The lateral talocalcaneal and dorsolateral calcaneocuboid ligaments had varying positional attachments. Osteochondral lesions were present in 86% of specimens with the majority in the talocrural joint. Of the 235 lesions identified, 31 were grade 3 or above. Ligament tears occurred in 2% of all ligaments observed. Tears in the lateral talocalcaneal, medial calcaneocuboid, and dorsolateral calcaneocuboid ligaments were associated with an increased number of hindfoot OCLs. CONCLUSION: We demonstrated the prevalence of morphologic ligament and joint surface variants, ligament tears, and osteochondral lesions in the hindfoot. Tears in ligaments stabilizing the calcaneocuboid joint were implicated in an increase in hindfoot joint damage. CLINICAL RELEVANCE: We believe anatomic studies can be used to clarify the association between traumatic injuries and their sequelae.

Nonoperative treatment of bimalleolar equivalent ankle fractures: a retrospective review of 51 patients.

The purpose of this retrospective study was to determine the outcome of bimalleolar equivalent ankle fractures in patients who were treated nonoperatively. The charts of 214 patients with isolated Weber B (supination-external rotation pattern) fibula fractures were reviewed. Fifty-one patients met the inclusion criteria and were administered the American Orthopaedic Foot and Ankle Society Ankle and Hindfoot Functional Survey by telephone or personal interview. The average medial clear space was 5.09 mm; the average American Orthopaedic Foot and Ankle Society Ankle and Hindfoot Functional Survey score was 84.22. A medial clear space of 4, 5, 6, and 7 mm resulted in American Orthopaedic Foot and Ankle Society Ankle and Hindfoot Functional Survey scores of 90.22, 89.4, 72.0 and 63.17, respectively. Further analysis showed significant differences in American Orthopaedic Foot and Ankle Society Ankle and Hindfoot Functional Survey scores between the 4 mm medial clear space group and the 6 mm and 7 mm medial clear space groups; the 5 mm medial clear space group and the 6 mm and 7 mm groups. Our results suggest that medial tenderness and ecchymosis alone are not sufficient to meet operative criteria, a higher medial clear space on stress gravity views correlates with a lower American Orthopaedic Foot and Ankle Society Ankle and Hindfoot Functional Survey score, and that there are significant differences in American Orthopaedic Foot and Ankle Society Ankle and Hindfoot Functional Survey scores between groups with medial clear space 4 to 7 mm. ACFAS Level of Clinical Evidence: 2b.

Protein C deficiency: podiatric medical relevance and case report.

We describe the management of a patient who presented to a family-practice clinic with gangrenous digits. After a thorough evaluation, she was found to have protein C deficiency, which produced a hypercoagulable state. Differential diagnosis in the evaluation of the coagulopathic patient with appropriate hematologic tests is briefly discussed.