Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT05287646

Conditions

Amputation, Lower Limb

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Suction Suspension First

Elevated Vacuum Suspension First

Study Details

Brief summary:

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.

Conditions

Amputation, Lower Limb

Study ID

NCT05287646

Start date

Jan 5, 2024

Status verified date

Apr, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

21 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Suction Suspension First

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

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.

Primary outcome measure

  • Changes in dynamic residual tibia kinematics between suspension techniques [ Time Frame: 4 weeks post socket fit ]
  • Changes in dynamic skin deformation of the residual limb between suspension techniques [ Time Frame: 4 weeks post socket fit ]

Central Contacts and Locations

Central contacts

Locations

VA NY Harbor Healthcare System, New York, NY

Recruiting

New York, New York, United States, 10010-5011

Contacts

Principal Investigator:

Jason Maikos, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • Prosthesis Fitting
  • Prosthetic Suspension Systems
  • Dynamic Stereo X-Ray
  • Biplanar Fluoroscopy
  • Transtibial Amputation
  • Pistoning
  • Elevated Vacuum Suspension
  • Suction Suspension
  • Lower Extremity Amputation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-22.