Validation and Utility of a Novel Foot Offloading Device: Improving Pain and Function.

BACKGROUND: Foot pain is a common presentation, and management is generally geared toward pressure offloading. Although several pressure offloading devices exist on the market, the search for the optimal device is ongoing. METHODS: We recently developed PopSole, an inexpensive, simple, balanced offloading insole focused on reducing targeted foot pain. We conducted a prospective validation study of patients with foot pain lasting longer than 6 months to assess the durability and efficacy of the device with follow-up scheduled at 2 weeks, 4 weeks, 2 months, and 3 months. Patient-reported outcomes were collected using multiple validated surveys. Fifteen patients were enrolled in this study. RESULTS: At 4 weeks, pain, function, and quality of life across all surveys showed statistically significant improvement. For the 6 patients with long-term outcomes (3 months), patients reported improvement in their pain, function, and quality of life across all surveys, which were significant in the Mayo survey (P = .018), the Manchester Foot Pain and Disability Index (P = .014), the American Orthopaedic Foot and Ankle Society ankle-hindfoot scale (P = .032), the Foot and Ankle Ability Measure activities of daily living (P = .009), and the Pittsburgh foot survey (P = .01); the Foot and Ankle Ability Measure sports approached statistical significance (P = .058). CONCLUSIONS: The PopSole is a durable and effective device to relieve foot pain, improve function, and improve quality of life for up to 3 months of use.

Vitamin D3 Improves Adipose Stromal Cell Survival and Human Fat Graft Retention in Xenograft Model.

Adipose stem cells are considered one of the primary drivers of autologous fat graft biologic activity and survival. We have previously demonstrated that hormonally active VD3 improved adipose stem cell viability in ex vivo and in vivo fat grafting models. In this study, we evaluated the inactive form of VD3 (cholecalciferol) on adipose stromal cell (ASC) phenotype during hypoxia and the subsequent effect on human fat graft retention in the xenograft model. Lipoaspirate collected from six human donors was used for ex-vivo particle culture studies and isolated ASC studies. Adipose particles were treated with increasing doses of VD3 to determine impact on ASC survival. Expanded stromal cells were treated with VD3 during hypoxic culture and assessed for viability, apoptosis, mitochondrial activity, and nitric oxide release via caspase, DAF-FM, or TMRM. Finally, forty Nu/J mice receiving bilateral dorsal human lipoaspirate were treated thrice weekly with 1) Vehicle control, 2) 50ng calcitriol, 3) 50ng VD3, 4) 500ng VD3, and 5) 5000ng VD3 for 12 weeks, n=8 per group. Graft weight, volume, and architecture were analyzed. Adipose particles treated with dose escalating VD3 had significantly increased ASC viability compared to control (p<0.01). Under hypoxia, ASCs treated with 1nM VD3 had significantly greater viability than untreated and pre-treated cells (p<0.01, p<0.01) and significantly lower apoptosis-to-viability ratio (p<0.01). ASCs pre-treated with 1nM VD3 had significantly lower nitric oxide release (p<0.05) and lower mitochondrial polarization (p<0.05) compared to controls. In vivo results showed mice receiving 5000ng VD3 had significantly greater graft weight (p<0.05) and volume (p<0.05) after 12 weeks of treatment compared to controls. Grafts had enhanced neovascularization, intact adipocyte architecture, and absence of oil cysts. VD3 is an over-the-counter nutritional supplement with a known safety profile in humans. Our xenograft model suggests administering VD3 at the time of surgery may significantly improve fat graft retention.

A Bibliometric Analysis of the 50 Most Cited Articles on Body Contouring Surgery After Massive Weight Loss.

BACKGROUND: Body contouring surgery after massive weight loss has emerged a safe and reliable option to improve self-esteem, social life, work ability, physical activity, and sexual activity, and it is considered as an essential step in the multidisciplinary approach to morbid obesity. In this study, we aim to provide a comprehensive overview of the current state of literature on body contouring after massive weight loss, identifying research trends and areas for future investigation. METHODS: The Web of Science Core Collection was used to identify the 50 most cited publications on post-massive weight loss surgery. Data collected from each article included: title, journal, publication year, total citations, average citations per year, authors, study type, study topic, country, and institution of origin. RESULTS: The top 50 most-cited articles include 44 original articles and 6 review articles. The most cited article, published by Lockwood in 1991, received a total of 224 citations. The research areas included surgical outcomes and complications (n=19, 38%), psychological aspects such as body image, quality of life and desire for body contouring procedures (n=18, 36%), surgical techniques (n=11, 22%), an anatomical study (n=1, 2%), and a classification system (n=1; 2%). Plastic and Reconstructive Surgery journal published most (44%) of the papers identified. The University of Pittsburgh was the single institution that contributed the most (n=11; 22%). CONCLUSION: This bibliometric analysis provides insights and research trends for clinicians interested in body contouring after massive weight loss, facilitating the understanding and evolution of post-bariatric surgery and elucidating the rationale behind current practice. NO LEVEL ASSIGNED: This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Analyzing the Impact of Social and Psychiatric Factors in Patients Who Undergo Body Contouring Procedures.

BACKGROUND: As the prevalence of obesity increases, the number of patients seeking body contouring procedures after bariatric surgery for massive weight loss is increasing. Although the positive impact of bariatric surgery on physical and emotional health is well-described, few studies have reported on the psychosocial well-being of patients undergoing body contouring procedures. Psychosocial well-being can impact patient satisfaction and maintenance of weight loss, and is an important area to study. OBJECTIVE: The aim of this study was to characterize social and psychiatric factors of patients undergoing body contouring surgery, and to evaluate their impact on maintenance of weight loss. METHODS: A retrospective review was performed of patients who presented to a single institution for body contouring procedures between 2002 and 2018. Demographic details, medical history, psychosocial support, and operative details were collected. Univariate analysis and multinomial logistic regressions were performed with R statistical software (version 1.3.1093). RESULTS: A total of 1187 patients underwent at least 1 body contouring procedure during the study time frame. Mean BMI at presentation was 31.21 ± 10.49 kg/m2. Patients diagnosed with obesity at age 18 or older had significantly greater odds of suffering from generalized anxiety disorder (odds ratio [OR] 1.08 [95% CI, 1.02-1.15], P = .008). Patients with spousal support had 1.93 times higher odds of having maintained postbariatric weight loss at their 6-month follow-up (OR 1.93 [95% CI, 1.84-2.01], P = .028). CONCLUSIONS: Social support and age of obesity diagnosis impact psychological well-being and maintenance of weight loss following body contouring procedures.

Active Vitamin D3 (Calcitriol) Increases Adipose Graft Retention in a Xenograft Model.

BACKGROUND: Autologous fat grafting, although broadly indicated, is limited by unsatisfactory retention and often requires multiple procedures to achieve durable outcomes. Graft survival is strongly influenced by the magnitude and duration of post-engraftment ischemia. Calcitriol is a pleiotropic, safe nutrient with cell-specific influence on viability and metabolic flux. OBJECTIVES: Evaluate the efficacy of activated vitamin D3 (calcitriol) in improving grafting outcomes and examine its mechanisms. METHODS: Lipoaspirate was collected for ex vivo culture (7 unique donors), in vitro bioenergetic analysis (6 unique donors), and in vivo transplantation (5 unique donors). Ex vivo samples were incubated for up to 2 weeks before extraction of the stromal vascular fraction (SVF) for viability or flow cytometry. SVF was collected for Seahorse (Agilent; Santa Clara, CA) analysis of metabolic activity. Human endothelial cell lines were utilized for analyses of endothelial function. In vivo, samples were implanted into athymic mice with calcitriol treatment either (1) once locally or (2) 3 times weekly via intraperitoneal injection. Grafts were assessed photographically, volumetrically, and histologically at 1, 4, and 12 weeks. Hematoxylin and eosin (H&E), Sirius red, perilipin, HIF1α, and CD31 tests were performed. RESULTS: Calcitriol-treated lipoaspirate demonstrated dose-dependent increases in SVF viability and metabolic reserve during hypoxic stress. Calcitriol treatment enhanced endothelial mobility ex vivo and endothelial function in vitro. In vivo, calcitriol enhanced adipocyte viability, reduced fibrosis, and improved vascularity. Continuous calcitriol was sufficient to improve graft retention at 12 weeks (P < .05). CONCLUSIONS: Calcitriol increased fat graft retention in a xenograft model. Calcitriol has potential to be a simple, economical means of increasing fat graft retention and long-term outcomes.

Comparison of Clinically Relevant Adipose Preparations on Articular Chondrocyte Phenotype in a Novel In Vitro Co-Culture Model.

Adipose therapeutics, including isolated cell fractions and tissue emulsifications, have been explored for osteoarthritis (OA) treatment; however, the optimal preparation method and bioactive tissue component for healing has yet to be determined. This in vitro study compared the effects of adipose preparations on cultured knee chondrocytes. De-identified human articular chondrocytes were co-cultured with adipose preparations for 36 or 72 h. Human adipose tissues were obtained from abdominal panniculectomy procedures and processed using three different techniques: enzymatic digestion to release stromal vascular fraction (SVF), emulsification with luer-to-luer transfer (nanofat), and processing in a bead-mill (Lipogems, Lipogems International SpA, Milan, Italy). Gene expression in both chondrocytes and adipose preparations was measured to assess cellular inflammation, catabolism, and anabolism. Results demonstrated that chondrocytes cultured with SVF consistently showed increased inflammatory and catabolic gene expression compared with control chondrocytes at both 36- and 72-h timepoints. Alternatively, chondrocytes co-cultured with either nanofat or bead-mill processed adipose derivatives yielded minimal pro-inflammatory effects and instead increased anabolism and regeneration of cartilage extracellular matrix. Interestingly, nanofat preparations induced transient matrix anabolism while Lipogems adipose consistently demonstrated increased matrix synthesis at both study timepoints after co-culture. This evaluation of the regenerative potential of adipose-derived preparations as a clinical tool for knee OA treatment suggests that mechanically processed preparations may be more efficacious than an isolated SVF cell preparation.

The General Registry of Autologous Fat Transfer: Concept, Design, and Analysis of Fat Grafting Complications.

BACKGROUND: The American Society of Plastic Surgeons and The Plastic Surgery Foundation launched GRAFT, the General Registry of Autologous Fat Transfer, in October of 2015. This web-accessible registry addresses the need for prospective and systematic data collection, to determine the rates of unfavorable outcomes (complications) of fat grafting. Understanding and avoiding the factors that lead to complications can help establish safe practices for fat grafting. METHODS: Data collected between October of 2015 and November of 2019 were summarized for age, sex, indications, processing techniques, and fat graft volume. Rates of complications for fat grafting to various anatomical areas were calculated. RESULTS: The General Registry of Autologous Fat Transfer collected data on 7052 fat grafting procedures from 247 plastic surgery practices. The mean age of the patients in the registry was 51 years (range, 1 to 89 years), 94 percent were female, and 64 percent of the procedures were for aesthetic indications. Whereas the overall complication rate was low (5.01 percent), the complication rates for fat grafting to the breast and buttocks (7.29 percent and 4.19 percent, respectively) were higher than those for face and other areas (1.94 percent and 2.86 percent, respectively). Oil cysts (2.68 percent) and infections (1.64 percent) were the most common complications of breast fat grafting, whereas seroma (1.84 percent) and palpable mass (1.33 percent) were most common for fat grafting to buttocks. Palpable mass (0.54 percent) and infections (0.54 percent) were most common for fat grafting to face. CONCLUSIONS: The General Registry of Autologous Fat Transfer provides a valuable tool for prospective tracking of fat grafting techniques and complications. Data collected in the registry show low rates of complications for all recipient areas treated with fat grafting. CLINICAL RELEVANCE STATEMENT: GRAFT collects real world data on complications of autologous fat grafting procedures. The data collected over 4 years shows low rates of complications for fat grafting. The benchmarking tools available in GRAFT can help enhance techniques and safety of fat grafting. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

Perforating Fat Injections for Chronic Plantar Fasciitis: A Randomized, Crossover Clinical Trial.

SUMMARY: Plantar fasciitis affects 2 million patients per year. Ten percent of cases are chronic, with thickened plantar fascia. Treatment may lead to prolonged recovery, foot instability, and scar. The authors hypothesized that perforating fat injections would decrease plantar fascia thickness, reduce pain, and improve quality of life. Adults with plantar fascia greater than 4 mm for whom standard treatment had failed were included in a prospective, randomized, crossover pilot study. Group 1 (intervention) was followed for 12 months. Group 2 was observed for 6 months, injected, and then followed for 6 months. Validated patient reported outcome measures, ultrasound, and complications were assessed. Group 1 had nine female patients and group 2 had five patients. A total of 2.6 ± 1.6 ml of fat was injected per foot at one to two sites. In group 1, plantar fascia thickness decreased from screening at 6 and 12 months (p < 0.05). Group 2 had decreased plantar fascia thickness from screening to 6 months after injection (p < 0.05). Group 1 had pain improvements at 6 and 12 months compared with screening (p < 0.01). Group 2 reported no pain difference after injections (p > 0.05). Group 1 had improved activities of daily living and sports activity at 6 and 12 months compared with screening (p < 0.003). Group 2 noted increased sports activity 6 months after injection compared with screening (p < 0.03). In conclusion, perforating fat injections for chronic plantar fasciitis demonstrate significant improvement in pain, function, and plantar fascia thickness. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Prospective Cohort Validation Study of a Novel Foot Offloading Device.

Pressure offloading is often considered a crucial factor affecting healing after a foot injury. We have devised a novel foot offloading device (PopSole) which allows for immediate customization of the area where there is foot pain and allows for adjustable arch support and metatarsal pad height while maintaining patient stability. We hypothesize that pain and function outcomes will improve significantly after use of the device over a 1-month period. Ten participants with foot pain for longer than 6 months completed five validated outcome questionnaires during three visits (initial screening, at 2 weeks, and at 4 weeks). Devices were deflated in areas of pain specific for each patient. Validated patient reported outcomes measures showed significant improvement in pain and function from baseline to week two (r = 0.644, P < 0.05), (r = 0.43, P < 0.05), and (r = 0.552, P < 0.05), respectively, and the Foot & Ankle Ability Measure (FAAM) showed improved ability in activities of daily living (r = 0.58, P < 0.05) and sports (r = 0.69, P < 0.05). All 10 patients reported pain relief during at least one visit and/or an ability to return to standing-based activities that they previously were unable to do. PopSole rapidly improved pain and function, with sustained relief through 4 weeks. Current studies are in progress to assess long-term durability of the device and potential modifications to be made before future randomized studies to assess pressure and gait assessment, shear forces, and diabetic foot ulcer mitigation.

Incision Location Predicts 30-Day Major Adverse Events after Cosmetic Breast Augmentation: An Analysis of the Tracking Outcomes and Operations for Plastic Surgeons Database.

BACKGROUND: Enhanced understanding of early postoperative adverse events will improve patient counseling and preoperative risk modification to decrease complications in implant-based breast augmentation. This study seeks to evaluate the early major adverse events following cosmetic breast augmentation. METHODS: A retrospective cohort analysis of the Tracking Outcomes and Operations for Plastic Surgeons database was performed to identify any women undergoing augmentation mammaplasty with an implant between 2008 and 2016. RESULTS: A total of 84,296 patients were studied. Major adverse events were identified in 0.37 percent. Seroma requiring drainage was observed in 0.08 percent, hematoma requiring drainage was observed in 0.15 percent, deep wound disruption was observed in 0.09 percent, and implant loss was observed in 0.11 percent. The authors identified multiple independent predictors of major adverse events, including body mass index greater than 30 kg/m2 (relative risk, 2.05; p < 0.001), tobacco use (relative risk, 2.25; p < 0.001), and diabetes mellitus (relative risk, 1.8; p < 0.05). Use of a periareolar incision significantly increased the risk of developing an early postoperative complication (relative risk, 1.77; p < 0.001). CONCLUSIONS: The findings of this study indicate an early major adverse event rate following cosmetic breast augmentation with implants of 0.37 percent. The authors identified multiple independent predictors of major adverse events, including body mass index greater than 30 kg/m2, tobacco use, and diabetes mellitus. In addition, when controlling for other factors, periareolar incision significantly increased the risk for major adverse events, when compared to an inframammary incision. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Update on Liposuction: What All Plastic Surgeons Should Know.

LEARNING OBJECTIVES: After studying this article, the participant should be able to: 1. Understand the types of tumescence available for liposuction. 2. Explain the various modalities available for liposuction. 3. Describe the patient selection, staging, and complications associated with debulking liposuction. 4. Describe ways to optimize outpatient liposuction. SUMMARY: Liposuction is one of the most common procedures performed by board-certified plastic surgeons and is likely greatly underestimated, given underreporting of office procedures and the number of non-plastic surgeons performing these operations. With the ever-increasing popularity of liposuction, various methodologies and technology have been designed to make this task simpler and faster for the surgeon and hasten the recovery for the patient. In the past 10 years, over 50 devices or techniques have been released to assist, refine, or altogether replace liposuction. With the advent of these newer tools, a thorough Continuing Medical Education study was performed to review the available literature.

A Step in the Right Direction: A Prospective Randomized, Controlled Crossover Trial of Autologous Fat Grafting for Rejuvenation of the Heel.

BACKGROUND: The shock-absorbing soft tissues of the heel are composed of dermis and specialized fat pads. Heel fat pad atrophy is common and can be painful and debilitating. In our previous work, autologous fat grafting was effective for treating pain from forefoot fat pad atrophy. OBJECTIVES: The authors hypothesized that autologous fat grafting to the heel would relieve pain and improve function in patients with heel fat pad atrophy. METHODS: Patients with heel fat pad atrophy and associated pain were recruited and randomized into 2 groups. Group 1 received autologous fat grafting on enrollment and was followed for 2 years. Group 2 received offloading and activity modification for 1 year, then crossed over, underwent autologous fat grafting, and was followed for 1 year afterward. Outcome measures included ultrasound-measured fat pad and dermal thickness; pedobarograph-measured foot pressures and forces; and patient-reported outcomes as measured by the Manchester Foot Pain and Disability Index. RESULTS: Thirteen patients met the inclusion criteria and completed the study. Seven (12 affected feet) were randomized into Group 1; and 6 (9 affected feet) were randomized into Group 2. The average age was 55 years and BMI was 30.5 kg/m2. Demographics did not significantly differ between groups. Heel fat pad thickness increased after autologous fat grafting but returned to baseline at 6 months. However, autologous fat grafting increased dermal thickness significantly and also increased fat pad thickness under a compressive load compared with controls at 6 and 12 months. Foot pain, function, and appearance were also significantly improved compared with controls at 6 and 12 months. CONCLUSIONS: Autologous fat grafting improved patient-reported foot pain, function, and appearance and may rejuvenate local soft tissues in patients with heel fat pad atrophy.

A New Device for Autologous Small Volume Fat Grafting.

BACKGROUND: Many techniques and devices have been developed to improve small volume fat grafting efficiency and consistency for use in the operating room and outpatient procedure room. These methods require cumbersome or messy processing to remove excess oil and fluid from adipose graft. OBJECTIVES: The aim of this study was to compare the fat processing efficiency of a novel handheld device, the Push-to-Spin (P2S) system, with that of other common processing techniques and validate tissue quality after lipoaspirate processing. METHODS: Human lipoaspirate samples were processed by 1 of 3 methods: cotton gauze (Telfa) rolling, centrifugation (Coleman technique), or the P2S system. Efficiency of fat processing was evaluated in terms of total processing time, fat harvest ratio, and fat processed ratio. Histologic examination and immunohistochemical staining were used to compare tissue morphology and adipocyte viability, respectively. Experimental samples were compared with unprocessed lipoaspirate controls. RESULTS: Lipoaspirate processing was significantly faster with the P2S device than with other techniques. All 3 methods achieved similar fat harvest and fat processing ratios. Additionally, the P2S, Telfa, and Coleman techniques yielded grafts with similar cellularity and with similar perilipin and glycerol-3-phosphate dehydrogenase 1 expression. Measured differences between experimental and control samples were statistically significant. CONCLUSIONS: The P2S device is an easy-to-use, efficient, and potentially cost-effective handheld device that can be used for lipoaspirate harvest, processing, and grafting in any procedural setting. The resulting adipocytes have similar morphology, viability, and function to those yielded by other techniques. This handheld technology decreases procedure time, thereby improving surgeon efficiency and patient experience.

Contact Pressures Between the Rearfoot and a Novel Offloading Insole: Results From a Finite Element Analysis Study.

Pressure offloading is critical to diabetic foot ulcer healing and prevention. A novel product has been proposed to achieve this offloading with an insole that can be easily modified for each user. This insole consists of pressurized bubbles that can be selectively perforated and depressurized to redistribute weight to the nonulcer region of the foot. However, the effect of the insole design parameters, for example, bubble height and stiffness, on offloading effectiveness is unknown. To this end, a 3-dimensional finite element model was developed to simulate contact between the rearfoot and insole. The geometry of the calcaneus bone and soft tissue was based on the medical images of an average male patient, and material properties and loading conditions based on the values reported in the literature were used. The model predicts that increasing bubble height and stiffness leads to a more effectively offloaded region. However, the model also predicts that increasing stiffness leads to increasing contact pressures on the surrounding soft tissue. Thus, a combination of insole design parameters was determined, which completely offloads the desired region, while simultaneously reducing the contact pressure on the surrounding soft tissue. This design is expected to aid in diabetic foot ulcer healing and prevention.