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Quantifying Bone and Skin Movement in the Residual Limb of Individuals With Transtibial Amputation Using Dynamic Stereo X-Ray

Quantifying Bone and Skin Movement in the Residual Limb-Socket Interface of Individuals With Transtibial Amputation Using Dynamic Stereo X-Ray

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* Unilateral transtibial amputation (any etiology)
* At least 18 years old
* At least 6-months post-amputation
* Current prosthetic users (at least 6 hours/day)

Exclusion Criteria:

* Unable to ambulate on a treadmill at low to moderate speed
* Inability to tolerate the socket suspensions
* Length of the residual limb prohibits socket fitting, dynamic stereo x-ray data capture, or marker placement
* Mental impairment that impedes study compliance
* Skin conditions (i.e. burns or poor skin coverage) as well as those with severe contractures that prevent prior prosthetic wear
* Severe neuropathy, uncontrolled diabetes, have insensate foot, severe phantom pain, or a significant history of skin ulcers
* Any other significant comorbidity that would interfere with the study
* Severe circulatory problems including peripheral vascular disease and pitting edema
* Cognitive deficits or mental health problems that would limit ability to participate fully in the study protocol
* Women who are pregnant or who plan to become pregnant during the study

About the study

Individuals with lower extremity amputation are often challenged by complications that arise from poor prosthetic fit, including movement of the residual limb in the socket, known as pistoning. Pistoning can lead to gait instability, skin problems, and pain. Different prosthetic suspension systems have been developed to decrease this motion, including elevated vacuum suspension, which utilizes a pump to draw air from the socket. However, scientific analyses to understand the movement between the limb and socket have yet to be performed with a high level of accuracy. This study will use a state-of-the art imaging technique, known as dynamic stereo x-ray, to quantify the 3D movement of the residual limb in the socket. It is hypothesized that dynamic stereo x-ray will be a sensitive method to measure differences in residual limb movement between 2 different socket suspension techniques: suction and elevated vacuum suspension. This information is critical for advancing prosthetic treatments to reduce secondary conditions and degenerative changes that result from poor prosthetic fit.

What is being tested

• Suction Suspension First (device)
• Elevated Vacuum Suspension First (device)

Sponsor: VA Office of Research and Development · Participants: 21 · Started: Jan 5, 2024

Contact the study team

• Jason Maikos, PhD · Phone: (212) 686-7500
• Michael J Hyre, MS · Phone: (212) 686-7500

Official record on ClinicalTrials.gov — NCT05287646

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.