Improved Self-Reported Comfort, Stability, and Limb Temperature Regulation with an Immediate Fit, Adjustable Transtibial Prosthesis

Chloe McCloskey, Jessica Kenia, Frances Shofer, Jim Marschalek, Timothy Dillingham, Chloe McCloskey, Jessica Kenia, Frances Shofer, Jim Marschalek, Timothy Dillingham

Abstract

Objective: The purpose of this investigation was to assess participants' self-reported satisfaction with an adjustable, immediate fit transtibial prosthetic system as compared to their conventionally fabricated prosthetic device.

Design: A prospective study involving a two-week single-group pre-post intervention design.

Setting: Physical medicine and rehabilitation clinic of a university hospital.

Participants: Adults (N=27) with transtibial limb loss.

Intervention: Participants were fit with the iFIT prosthetic system and instructed to wear it for a two-week evaluation period.

Main outcome measure: A modified PEQ scale was completed on the participant's conventional prosthetic during the initial visit and the iFIT system after the two weeks.

Results: Twenty-seven persons with lower limb loss were enrolled. Three were lost to follow up leaving twenty-four subjects with completed data. Three subjects had recent amputations with no conventional device for comparison. The Modified PEQ scores were significantly higher for the iFIT prosthetic in comparison to their conventional device (29.18 [SD= 4.63] vs 23.82 [SD=6.38], p <0.01). Subjects were also found to perceive significantly better temperature control with the iFIT prosthetic system (4.19 [SD= 0.68] vs 2.97 [SD=1.02], p <0.001). Subjects did not report any skin breakdown, prosthetic issues, or falls.

Conclusion: This immediate fit, adjustable transtibial prosthesis demonstrated significantly better patient satisfaction and temperature perception compared to conventional devices. These results are consistent with previous findings and further support the efficacy of an immediate fit adjustable transtibial prosthetic system. Longer term studies in the United States and internationally are underway to assess the durability and efficacy of this new prosthesis in different populations and settings.

Keywords: Prosthesis; diabetes; lower limb amputation; transtibial amputation.

Figures

Fig 1
Fig 1
Lateral view of the iFIT prosthesis showing locking buckle closure system.
Fig 2
Fig 2
Average difference between iFIT and conventional prosthesis according to PEQ-based questionnaire data based on the 21 participants completing the study who had conventional devices prior to using the adjustable test prosthesis.

References

    1. Ziegler-Graham K., Mackenzie E.J., Ephraim P.L., Travison T.G., Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008;89:422–429.
    1. Owings M.F., Kozak L.F. Ambulatory and inpatient procedures in the United States, 1996. Vital Health Stat 13. 1998;11:1–119.
    1. Sheehan T.P., Gondo G.C. Impact of limb loss in the United States. Phys Med Rehabil Clin. 2014;25:9–28.
    1. Varma P., Stineman M.G., Dillingham T.R. Epidemiology of limb loss. Phys Med Rehabil Clin N Am. 2015;25:1–8.
    1. Malone J.M., Snyder M., Anderson G., Bernhard V.M., Holloway G.A., Jr., Bunt T.J. Prevention of amputation by diabetic education. Am J Surg. 1989;158:520–524.
    1. Singh N., Armstrong D.G., Lipsky B.A. Preventing foot ulcers in patients with diabetes. JAMA. 2005;293:217–228.
    1. MacKenzie E.J., Castillo R.C., Jones A.S. Health-care costs associated with amputation or reconstruction of a limb-threatening injury. J Bone Joint Surg Am. 2007;89:1685–1692.
    1. Cummings D. Prosthetics in the developing world: a review of the literature. Prosthet Orthot Int. 1996;20:51–60.
    1. Quigley M. Prosthetic management: overview, methods, and materials. In: Bowker H.K., Michael J.W., editors. Atlas of Limb Prosthetics: surgical, prosthetic and rehabilitation principles. Chap 4. 2nd ed. American Academy of Orthopedic Surgeons; Rosemont, IL: 1992.
    1. Dillingham T.R., Pezzin L.E., MacKenzie E.J., Burgess A.R. Use and satisfaction with prosthetic devices among persons with trauma-related amputations: a long-term outcome study. Am J Phys Med Rehabil. 2001;80:563–571.
    1. Dillingham T.R., Kenia J., Shofer F. A prospective assessment of an adjustable, immediate fit, transtibial prosthesis. PM R. 2019;11:1210–1217.
    1. Legro M.W., Reiber G.D., Smith D.G. Prosthesis evaluation questionnaire for persons with lower limb amputations: assessing prosthesis-related quality of life. Arch Phys Med Rehabil. 2008;79:931–938.
    1. Baars E.T., Geertzen J.B. Literature review of the possible advantages of silicon liner socket use in trans-tibial prostheses. Prosthet Orthot Int. 2005;29:27–37.
    1. Berke G.M., Fergason J., Milani J.R. Comparison of satisfaction with current prosthetic care in veterans and servicemembers from Vietnam and OIF/OEF conflicts with major traumatic limb loss. J Rehabil Res Dev. 2010;47:361–371.
    1. Webster J.B., Crunkhorn A., Sall J. Clinical practice guidelines for the rehabilitation of lower limb amputation: an update from the Department of Veterans Affairs and Department of Defense. Am J Phys Med Rehabil. 2019;98:820–829.
    1. Dillingham T.R., Pezzin L.E., MacKenzie E.J. Limb amputation and limb deficiency: epidemiology and recent trends in the United States. South Med J. 2002;95:875–883.
    1. International Organization for Standardization Prosthetics–structural testing of lower-limb prostheses–requirement and test methods. Available at: Accessed November 17, 2020.

Source: PubMed

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