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.

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.

Patient Selection for Pedal Soft Tissue Augmentation.

BACKGROUND: Pedal fat grafting has been shown to improve pain and functional impairment from forefoot fat pad atrophy. OBJECTIVES: The authors aimed to determine if patient demographics and foot characteristics play a role in the level of impact that is achieved following surgery. METHODS: The authors performed a retrospective review of patients who received forefoot autologous fat injections for the treatment of pedal fat pad atrophy. Patient improvement of pain and functional impairment were evaluated for correlation with patient characteristics, including gender, age, BMI, unilateral vs bilateral injections, flexible vs rigid arch, previous foot deformity or surgery, and presence of callus. RESULTS: Forty-four patients received fat injections into the ball of their foot; 73% of them were women; their mean age was 61 years, and mean BMI was 26.6 kg/m2; 75% had injections performed bilaterally; 41% had a flexible arch, 73% had a past history of pedal deformity or surgery, and 43% had callus. Only female gender was found to correlate with an improvement in pain from the time of surgery to 12 months later (P = 0.02). CONCLUSIONS: Bilateral rigid, high arched foot type is a risk factor for foot pain and disproportionately represented among these patients. The only patient characteristic found to be correlated with improvement in pain at 12 months post-surgery was female gender. BMI and laterality of injections impacted the course of improvement after surgery. Given current data, all patients with suspected pedal fat pad atrophy should be considered for soft tissue augmentation.

Volumetric Analysis in Autologous Fat Grafting to the Foot.

BACKGROUND: Pedal fat grafting is a safe, minimally invasive approach to treat pedal fat pad atrophy. Prior randomized controlled trials demonstrate that the fat as measured directly under the metatarsal heads disappears between 2 and 6 months after fat grafting, despite patients having relief for 2 years. The authors aim to use magnetic resonance imaging to further assess three-dimensional volume of fat in the foot after autologous fat grafting to help explain the mechanism for improved pain. METHODS: A prospective study was performed using magnetic resonance imaging before and at 6 months after pedal fat grafting to assess changes in the three-dimensional morphology of the fat. RESULTS: Seventeen patients (six men and 11 women) underwent injections with a mean volume of 5.8 cc per foot. At 6 months, patients demonstrated increased tissue thickness (p = 0.008) and volume (p = 0.04). Improvements were seen in pain (p < 0.05) and activity (p < 0.05). Foot pressures and forces were significantly decreased and positively correlated with increased fat pad volume (p < 0.05). CONCLUSIONS: Pedal fat grafting significantly increases metatarsal fat pad volume. The distribution of the fat may contribute to lasting clinical relief in these patients. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

The Influence of Fat Grafting on Skin Quality in Cosmetic Foot Grafting: A Randomized, Cross-Over Clinical Trial.

BACKGROUND: Pedal fat grafting is a cosmetic procedure to treat the functional and aesthetic sequelae of pedal fat pad atrophy. Fat grafting has been found to mitigate these symptoms, but the exact mechanism is unknown. OBJECTIVES: The authors hypothesized that pedal fat grafting may improve skin quality, accounting for prolonged symptomatic improvement despite loss of grafted fat. METHODS: Patients with pedal atrophy were enrolled in a randomized crossover clinical trial. Group 1 underwent fat grafting upon enrollment with 2-year follow-up. Group 2 was managed conservatively for 1 year then placed into the fat grafting group with 1-year follow-up. Patients underwent pedal ultrasounds to determine thicknesses of the fat pad and dermis, and photographs were taken to assess skin quality. RESULTS: Three men and 20 women with an average age of 63 ± 6 years and an average BMI of 26.0 ± 4.6 kg/m2 were enrolled in the study. Twenty-six feet were injected in Group 1 and 17 were injected in Group 2. Group 1 dermal thickness increased at 6 months post-injection (P < 0.05). This increase persisted through 24 months. Group 2 dermal thickness decreased prior to injection (P < 0.05) but returned to baseline after injection and through 12-month follow-up (P < 0.05). Fat pad thickness returned to baseline by study completion in both groups (P < 0.05). CONCLUSIONS: Pedal fat grafting yielded a significant, sustained increase in dermal thickness, though grafted fat was not retained. Fat grafting may improve skin quality, which could contribute to improved clinical outcomes despite loss of grafted fat.

Fat Grafting for Pedal Fat Pad Atrophy in a 2-Year, Prospective, Randomized, Crossover, Single-Center Clinical Trial.

BACKGROUND: By age 60, 30 percent of Americans suffer from fat pad atrophy of the foot. Forefoot fat pad atrophy results from long-term aggressive activity, genetically dictated foot type, multiple forefoot steroid injections, surgery, and foot trauma. METHODS: The authors present data from a 2-year, prospective, randomized crossover study performed to assess pain and disability indexes, fat pad thickness, forces, and pressures of stance and gait. Group 1 underwent fat grafting with 2 years of follow-up, and group 2 underwent conservative management for 1 year, then underwent fat grafting with 1 year of follow-up. RESULTS: Eighteen subjects (14 women and four men) constituted group 1. Thirteen subjects (nine women and four men) constituted group 2. Group 1 reported the worst pain at baseline and group 2 experienced the worst pain at 6- and 12-month standard-of-care visits; pain for both groups improved immediately following fat grafting and lasted through study follow-up (p < 0.05). Group 1 demonstrated functional improvements at 12, 18, and 24 months postoperatively (p < 0.05), whereas group 2 demonstrated the highest function at 12 months postoperatively (p < 0.05). Pedal fat pad thickness of subjects in group 1 increased postoperatively and returned to baseline thickness at 2 months postoperatively; subjects in group 2 experienced return to baseline thickness at 6 months postoperatively (p < 0.01). Forces and pressures of stance and gait increased over the 2 years of follow-up for group 1 (p < 0.05). CONCLUSION: Pedal fat grafting provides long-lasting improvements in pain and function, and prevents against worsening from conservative management. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

Autologous Fat Grafting for Pedal Fat Pad Atrophy: A Prospective Randomized Clinical Trial.

BACKGROUND: Pedal fat pad atrophy is associated with pain, decreased tissue thickness, and increased foot pressures. To date, no objective studies investigating the use of fat grafting to the forefoot have been performed. The authors hypothesize that pedal fat grafting can reduce pain, increase tissue thickness, and decrease pedal pressures. METHODS: A prospective randomized study was performed to assess tissue thickness, pain, and foot pressures. Group 1 underwent fat grafting immediately with 1-year follow-up, and group 2 underwent conservative management for 1 year. RESULTS: Thirteen patients (two men and 11 women) constituted group 1 and 12 patients (four men and eight women) constituted group 2. Ten patients in group 1 underwent bilateral injections with a mean volume of 4.8 cc per foot. Mean follow-up time was 11.1 ± 5.4 months for group 1 and 13.8 ± 4.2 months for group 2. At 1 year, group 1 demonstrated improved foot function (p = 0.022), pain (p = 0.022), and work/leisure activities (p = 0.021). Group 1 had no change in tissue thickness, whereas in group 2, the right third metatarsal tissue thickness decreased significantly (p = 0.036). Foot pressures in group 1 did not improve; however, group 2 had a significant increase in left foot pressure (p = 0.011). When comparing the groups at 1 year, group 2 had significantly higher foot pressures and forces than group 1 (p < 0.05). CONCLUSIONS: Pedal fat grafting significantly improves pain and disability outcomes, and prevents against worsening foot pressures. Future analysis will reveal whether fat grafting has lasting efficacy. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.