Background
There exists a need for an adjustable socket to accommodate residual limb volume and shape changes. Further, limb loss rates globally are rising and there is a large unmet need for affordable and accessible prosthetic systems.
Objective
To assess the utility of an immediate fit modular prosthetic system (iFIT Prosthetics, LLC).
Design
Prospective feasibility study involving a 2‐week single‐group pre‐post intervention study.
Setting
Physical Medicine and Rehabilitation gait laboratory.
Participants
Participants were at least 6 months post amputation and walking with a conventional prosthesis. They were free of skin wounds, other neurological disorders, and severe pain conditions.
Methods
Participants were fit with an immediate fit prosthesis and instructed to wear it for a 2‐week evaluation period. They were given a progressive wearing schedule and they completed outcome measurements at the 2‐week follow‐up.
Main Outcome Measurements
Self‐reported satisfaction, gait biomechanics, and intrasocket peak pressures.
Results
Twenty‐six participants entered the study, with 22 completing the single group pre‐post study. They averaged 50 years (SD ±10.2) of age; four were female. Sixteen were dysvascular and 10 were traumatic in etiology. Significant differences (P = .03) in self‐reported satisfaction were found in favor of the iFIT device 29.33 (SD ± 4.51) versus the conventional device 25.52 (SD ± 6.8). No falls or limb ischemia were reported. Gait biomechanics revealed no differences across any temporal characteristics. Intrasocket peak pressures were significantly lower for the iFIT prostheses overall (P = .0014), at the anterior tibia (P = .0002), and the lateral side of the residual limb (P = .013).
Conclusions
The iFIT transtibial prosthetic system appears to be safe in this short‐term single‐group pre‐post study. This study provided preliminary evidence to support the feasibility of the iFIT system. It compared favorably to participants' conventional prostheses across all outcome measures. With its cost, adjustability, and accessibility advantages, this device may prove useful for persons with transtibial amputations. A larger multicenter study is needed to confirm these results.
Level of Evidence
III
Background: Controversy continues regarding appropriate indications for posterior malleolus fracture fixation in unstable rotational trimalleolar ankle injuries, with limited data comparing gait in operatively treated trimalleolar ankle fractures vs control populations. The purpose of this study was to evaluate the effect of trimalleolar ankle fracture fixation on gait parameters in the early postoperative period as compared to a healthy control population. Methods: Adult patients having undergone operative treatment of isolated trimalleolar ankle fractures were eligible for inclusion. A total of 10 patients met the inclusion criteria and participated in the analysis. Patients were evaluated using standard parameters of human gait 6 months after their index procedures, with gait values compared to a population of 17 non–age-matched healthy control subjects in addition to literature values of healthy populations of younger and older subjects. Results: Significant differences were noted between the spatiotemporal gait parameters of healthy control subjects and patients who had undergone operative treatment of trimalleolar ankle fractures. However, within the fracture group itself, no differences were found between patients with or without posterior malleolar fixation for any of the tested gait parameters. When patients were compared to literature values of younger and older healthy control populations, they were found to have gait patterns more similar to older rather than younger individuals. Conclusion: Operative fixation of trimalleolar ankle fracture does not restore normal gait function in the early postoperative period. Fixation of the posterior malleolus in particular also does not appear to improve gait characteristics. Patients who undergo surgery for these injuries demonstrate gait patterns similar to those of healthy older adults. Level of Evidence: Level II, Therapeutic (prospective cohort study).
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