Foot Rejuvenation with Pedal Fat Grafting: A Randomized Cross-Over Clinical Trial
Stephanie E. Dreifuss, MD, Danielle Minteer, PhD, Beth Gusenoff, DPM, Jeffrey Gusenoff, MD.
University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Pedal fat pad atrophy is a devastating condition affecting 30% of patients over the age of 60 and impacting foot function, pain, and appearance. We have previously reported in a one-year randomized clinical trial that fat grafting to the foot results in statistically significant improvements in pain and quality of life outcomes, despite fat loss over time. We hypothesize that pedal fat grafting may benefit dermal and soft tissue thickness, which may account for the prolonged symptomatic improvement despite loss of the grafted fat.
Patients with fat pad atrophy of the forefoot were enrolled into a randomized cross-over clinical trial. Group 1 underwent fat grafting immediately upon enrollment with 2-year follow-up. Group 2 was managed conservatively for 1 year upon enrollment then crossed over into the fat grafting group with 1-year follow-up.
Fat was harvested utilizing the Coleman method and an average of 4-6 ccs of fat were injected into the ball of each affected foot. Patients followed up at 1, 2, 6 and 12 months postoperatively, at which times pedal ultrasounds were performed to determine thickness of the fat pad and the dermis overlying each metatarsal head.
Over the course of the study period, the Manchester Foot Pain and Disability Index, a validated survey assessing functional limitation, pain intensity, and personal appearance, was administered to study participants.
3 men and 20 women were included in the study with an average age of 63 (±6 years). The average BMI was 26.0 (±4.6 kg/m2). 26 feet were injected in Group 1, and 17 were injected in Group 2. There was no variance in BMI or age across groups.
In Group 1, fat pad thickness was increased until 12 months postoperatively (p<0.05). In Group 2, fat pad thickness was increased until 6 months postoperatively (p<0.05).
In Group 1, dermal thickness was greater in the 5th metatarsal at 12 months postoperatively (p<0.05). However, this difference was clinically negligible. In Group 2, there was no significant difference between dermal thickness preoperatively and at 12 months postoperatively.
With regard to clinical outcomes, Group 1 had significant improvement in pain through 24 months (p<0.001) and foot function through 18 months post-injection (p<0.05). Group 2 had significant improvement in pain and increased work and leisure activities through 6 months post-injection (p< 0.05).
Though fat grafting for pedal fat pad atrophy has minimal effect on the dermis 1 year after injection, it does have a significant impact on pain and function. These quality of life measures demonstrate a persistent improvement for up to 2 years, though fat volume is only shown to persist until 1 year.
Future studies are planned to evaluate the hypothesis that these findings may be attributed to dispersion of the grafted fat over time, allowing for fat-mediated rejuvenation of the pedal tissue without a measurable impact on fat pad or dermal thickness.
Given the impact of pedal fat grafting on function, pain, and quality of life, this technique may present a long-term solution for patients with debilitating fat pad atrophy.
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