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

Conditions

• Amputation, Lower Limb

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Suction Suspension First — DEVICE
  Participants will be fit with a socket capable of being suspended by both traditional suction and elevated vacuum. Participants will be assessed first with the elevated vacuum system inactive (traditional suction). Residual limb kinematics and skin deformation during movement tasks will be evaluated utilizing dynamic stereo x-ray. The evaluation will then be repeated with the elevated vacuum system active.
• Elevated Vacuum Suspension First — DEVICE
  Participants will be fit with a socket capable of being suspended by both traditional suction and elevated vacuum. Participants will be assessed first with the elevated vacuum system active. Residual limb kinematics and skin deformation during movement tasks will be evaluated utilizing dynamic stereo x-ray. The evaluation will then be repeated with the elevated vacuum system inactive.

Study Details

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.

Key Dates

Start date

Jan 5, 2024

Status verified

Apr 2026

Primary completion

Feb 28, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

21 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Arms

• Active Comparator: Suction Suspension First
  The residual limb will be imaged during dynamic activities while participants use suction suspension first, then while participants use elevated vacuum suspension. Dynamic stereo x-ray will take place 4-weeks after socket fitting.
• Active Comparator: Elevated Vacuum Suspension First
  The residual limb will be imaged during dynamic activities while participants use elevated vacuum suspension first, then while participants use suction suspension. Dynamic stereo x-ray will take place 4-weeks after socket fitting.

Primary Outcome Measure

Changes in dynamic residual tibia kinematics between suspension techniques [ Time Frame: 4 weeks post socket fit ]

Central Contacts

• Jason Maikos, PhD
  (212) 686-7500
  [email protected]
• Michael J Hyre, MS
  (212) 686-7500
  [email protected]

Locations (1)

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