Clinical Outcomes Following Treatment of Recurrent Talotarsal Joint Dislocation Using a Type II Extraosseous Talotarsal Stabilization Implant-A Long-Term Follow-Up Study.

Collapsing foot deformity (CFD) and its resulting sequelae caused by recurring talotarsal joint dislocation (RTTJD) affects pediatric and adult patients. An extraosseous talotarsal stabilization (EOTTS) procedure, a subset of subtalar arthroereisis (SA) procedures, is recommended as a minimally invasive, first in-line surgical treatment option for CFD. The aim of this multicenter, retrospective study was to evaluate patient-reported outcomes measures in patients who were treated for RTTJD with Type II EOTTS implants. Sixty-seven cases having a median age of 38 years (range: 10-74) with more than 5 years of follow-up were included in this study. The mean postoperative visual analog scale and Maryland Foot Score was 1.0 ± 1.9 and 92.3 ± 11.3, respectively, indicating excellent clinical outcomes. Subjectively, 88% cases reported as being satisfied with the outcome, 94% cases said they would recommend EOTTS, and 93% said that, if necessary, they would repeat it on their contralateral foot. A subgroup analysis revealed that while not statistically significant, clinical outcomes were slightly better in pediatric patients compared to adults. Implant removal rate was 4.5% (3 cases), and these were in the adult group only. Rate of minor issues such as pain, stiffness, discomfort, etc. was 15%; however, no serious adverse effects or complications were observed in any patient. This study suggests that EOTTS is an effective surgical treatment option wherein successful long-term clinical outcomes with low failure rates can be achieved in a select patient population.

ACFAS Clinical Consensus Statement: Acute Achilles Tendon Pathology.

Injuries to the Achilles tendon are a challenge to the foot and ankle surgeon. In recent years, research has led to a relative change in the way that many surgeons view acute Achilles tendon rupture. In an effort to fully evaluate these trends, as well as to evaluate all aspects of care for acute Achilles tendon rupture, the American College of Foot and Ankle Surgeons convened a panel of experts to create a clinical consensus statement to address selected aspects of care of the acute Achilles tendon injury.

A confirmatory study on the efficacy of dehydrated human amnion/chorion membrane dHACM allograft in the management of diabetic foot ulcers: A prospective, multicentre, randomised, controlled study of 110 patients from 14 wound clinics.

A randomised, controlled multicentre clinical trial was conducted at 14 wound care centres in the United States to confirm the efficacy of dehydrated human amnion/chorion membrane allograft (dHACM) for the treatment of chronic lower extremity ulcers in persons with diabetes. Patients with a lower extremity ulcer of at least 4 weeks duration were entered into a 2-week study run-in phase and treated with alginate wound dressings and appropriate offloading. Those with less than or equal to 25% wound closure after run-in were randomly assigned to receive weekly dHACM application in addition to offloading or standard of care with alginate wound dressings, for 12 weeks. A total of 110 patients were included in the intent-to-treat (ITT) analysis, with n = 54 in the dHACM group and n = 56 in the no-dHACM group. Of the participants, 98 completed the study per protocol, with 47 receiving dHACM and 51 not receiving dHACM. The primary study outcome was percentage of study ulcers completely healed in 12 weeks, with both ITT and per-protocol participants receiving weekly dHACM significantly more likely to completely heal than those not receiving dHACM (ITT-70% versus 50%, P = 0.0338, per-protocol-81% versus 55%, P = 0.0093). A Kaplan-Meier analysis was performed to compare the time-to-healing performance with/without dHACM, showing a significantly improved time to healing with the use of allograft, log-rank P < 0.0187. Cox regression analysis showed that dHACM-treated subjects were more than twice as likely to heal completely within 12 weeks than no-dHACM subjects (HR: 2.15, 95% confidence interval 1.30-3.57, P = 0.003). At the final follow up at 16 weeks, 95% of dHACM-healed ulcers and 86% of healed ulcers in the no-dHACM group remained closed. These results confirm that dHACM is an efficacious treatment for lower extremity ulcers in a heterogeneous patient population.

A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers.

The aim of this study was to determine the safety and effectiveness of dehydrated human umbilical cord allograft (EpiCord) compared with alginate wound dressings for the treatment of chronic, non-healing diabetic foot ulcers (DFU). A multicentre, randomised, controlled, clinical trial was conducted at 11 centres in the United States. Individuals with a confirmed diagnosis of Type 1 or Type 2 diabetes presenting with a 1 to 15 cm2 ulcer located below the ankle that had been persisting for at least 30 days were eligible for the 14-day study run-in phase. After 14 days of weekly debridement, moist wound therapy, and off-loading, those with ≤30% wound area reduction post-debridement (n = 155) were randomised in a 2:1 ratio to receive a weekly application of EpiCord (n = 101) or standardised therapy with alginate wound dressing, non-adherent silicone dressing, absorbent non-adhesive hydropolymer secondary dressing, and gauze bandage roll (n = 54). All wounds continued to have appropriate off-loading during the treatment phase of the study. Study visits were conducted for 12 weeks. At each weekly visit, the DFU was cleaned and debrided as necessary, with the wound photographed pre- and post-debridement and measured before the application of treatment group-specific dressings. A follow-up visit was performed at week 16. The primary study end point was the percentage of complete closure of the study ulcer within 12 weeks, as assessed by Silhouette camera. Data for randomised subjects meeting study inclusion criteria were included in an intent-to-treat (ITT) analysis. Additional analysis was conducted on a group of subjects (n = 134) who completed the study per protocol (PP) (EpiCord, n = 86, alginate, n = 48) and for those subjects receiving adequate debridement (EpiCord, n = 67, alginate, n = 40). ITT analysis showed that DFUs treated with EpiCord were more likely to heal within 12 weeks than those receiving alginate dressings, 71 of 101 (70%) vs 26 of 54 (48%) for EpiCord and alginate dressings, respectively, P = 0.0089. Healing rates at 12 weeks for subjects treated PP were 70 of 86 (81%) for EpiCord-treated and 26 of 48 (54%) for alginate-treated DFUs, P = 0.0013. For those DFUs that received adequate debridement (n = 107, ITT population), 64 of 67 (96%) of the EpiCord-treated ulcers healed completely within 12 weeks, compared with 26 of 40 (65%) of adequately debrided alginate-treated ulcers, P < 0.0001. Seventy-five subjects experienced at least one adverse event, with a total of 160 adverse events recorded. There were no adverse events related to either EpiCord or alginate dressings. These results demonstrate the safety and efficacy of EpiCord as a treatment for non-healing DFUs.

Randomized Controlled Trial of Micronized Dehydrated Human Amnion/Chorion Membrane (dHACM) Injection Compared to Placebo for the Treatment of Plantar Fasciitis.

BACKGROUND: Failure of conservative management to reduce/eliminate symptoms of plantar fasciitis (PF) may indicate need for advanced treatments. This study reports Level 1 evidence supporting 3-month safety and efficacy of micronized dehydrated human amnion/chorion membrane (dHACM) injection as a treatment for PF. METHODS: A prospective, single-blind, randomized controlled trial was conducted at 14 sites in the United States. Subjects were randomized to receive 1 injection, in the affected area, of micronized dHACM (n=73) or 0.9% sodium chloride placebo (n=72). Safety/efficacy assessments were conducted at 4 weeks, 8 weeks, 3 months, 6 months, and 12 months postinjection, using visual analog scale (VAS) for pain, Foot Function Index-Revised (FFI-R) score, and presence/absence of adverse events. Primary outcome was mean change in VAS score between baseline and 3 months expressed as difference in means for treatment versus control subjects. Secondary outcome was mean change in FFI-R score between baseline and 3 months expressed as difference in means for treatment versus control subjects. RESULTS: Baseline VAS scores were similar between groups. At the 3-month follow-up, mean VAS scores in the treatment group were 76% lower compared with a 45% reduction for controls ( P < .0001), FFI-R scores for treatment subjects had mean reduction of 60% versus baseline, whereas control subjects had mean reduction of 40% versus baseline ( P = .0004). Of 4 serious adverse events, none were related to study procedures. CONCLUSION: Pain reduction and functional improvement outcomes were statistically significant and clinically relevant, supporting use of micronized dHACM injection as a safe and effective treatment for PF. LEVEL OF EVIDENCE: Level I, prospective randomized trial.

Pediatric first ray deformities.

Pediatric first ray deformities may present in many ways similar to those effecting adults. However, these patients are not adults. Management of the patient and the deformity necessitates special consideration of timing, the patient's general health, techniques, and perhaps goals. Any simple broad brush approach to the care of these patients will certainly result in both undertreatment and overtreatment. The proper care of these patients is an ongoing process of appropriate management tailored to the patient's needs, deformities, and developmental age. Proper adherence to these recommendations can improve the patient's quality of life.

Diabetic foot ulcers treated with becaplermin and TheraGauze, a moisture-controlling smart dressing: a randomized, multicenter, prospective analysis.

BACKGROUND: It is hypothesized that moisture regulation specific to the area of contact results in local wound conditions more amenable to healing, which would result in faster and more frequent wound closure. TheraGauze is a new polymer-impregnated dressing designed to regulate moisture to a varying degree over the entire surface of a wound. METHODS: This prospective, randomized, multicenter study examined outcomes from treatment of diabetic foot ulcers with TheraGauze and TheraGauze in conjunction with becaplermin. We also compared these outcomes with historical data from the literature that used saline-moistened gauze and becaplermin. RESULTS: The rates of wound closure with TheraGauze and TheraGauze + becaplermin were 0.37 and 0.41 cm(2)/week, respectively (P = .34). The difference between these values was not statistically significant. We also observed high closure rates at 12 weeks (46.2% in both groups) and 20 weeks (61.5% with TheraGauze alone and 69.2% with TheraGauze + becaplermin). These data were also compared with historical data for closure rates (0.18 cm(2)/week) and percentage of wounds closed using saline-moistened gauze alone and becaplermin with saline-moistened gauze (0.24 cm(2)/week) from a variety of studies. CONCLUSIONS: Wounds in which moisture content was regulated with TheraGauze showed more rapid change in wound area and a higher percentage of wounds achieving closure at 12 and 20 weeks regardless of whether becaplermin was used.

Living cells or collagen matrix: which is more beneficial in the treatment of diabetic foot ulcers?

In a randomized multicenter study, 26 subjects with diabetes, neuropathy, and foot ulceration were treated with standard local wound care and application of either a living skin equivalent [LSE] (Dermagraft®, Advanced BioHealing, La Jolla, Calif) or extracellular matrix [ECM] collagen wound dressing (OASIS® Wound Matrix, Healthpoint, Fort Worth, Tex). Subjects were analyzed to confirm that the wounds, demographics, and health characteristics of subjects in each group were equivalent. Depending on the randomization, subjects received up to 3 applications of LSE or 8 applications of ECM. Subjects received this treatment in conjunction with standard saline dressings for a maximum of 12 weeks, and were observed for 20 weeks. No statistically significant difference was found in the size, distribution, or characteristics of the wounds evaluated in each group. There was no statistically significant difference in the time to closure or the rate of closure between the two groups. Similarly, no significant adverse events were reported in either group. The results of this study show comparable healing rates with use of either material. Further, it was hypothesized that both collagen and cellular components are necessary, and it is suggested that various conditions may make one or the other material more desirable.