Measuring bone and skin movement in amputees using advanced imaging

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

This study is testing how different types of prosthetic suspension systems affect the movement of the limb in people with a below-the-knee amputation during everyday activities.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 21 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: VA Office of Research and Development (fed)
• Locations: 1 site (New York, New York)
• Trial ID: NCT05287646 on ClinicalTrials.gov

What this trial studies

This study aims to quantify the movement of the residual limb in the prosthetic socket for individuals with transtibial amputation using dynamic stereo x-ray technology. By comparing two different prosthetic suspension systems—suction and elevated vacuum suspension—the research seeks to understand how these systems affect limb movement and socket fit during dynamic activities. The study will involve current prosthetic users who have been amputated for at least six months and will assess their limb movement in real-time. This innovative approach aims to fill the knowledge gap regarding the mechanics of the residual limb-socket interface, which is crucial for improving prosthetic design and patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with unilateral transtibial amputation who are current prosthetic users.

Not a fit: Patients with severe skin conditions, significant comorbidities, or those unable to ambulate may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better-fitting prosthetics, reducing pain and improving mobility for amputees.

How similar studies have performed: While there is limited data on dynamic assessments of limb-socket interaction, the use of advanced imaging techniques like dynamic stereo x-ray is a novel approach that has not been extensively tested in this context.

Eligibility criteria

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

Where this trial is running

New York, New York

• VA NY Harbor Healthcare System, New York, NY — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Jason Maikos, PhD — VA NY Harbor Healthcare System, New York, NY
• Study coordinator: Jason Maikos, PhD

Conditions: Amputation, Lower Limb, Prosthesis Fitting, Prosthetic Suspension Systems, Dynamic Stereo X-Ray, Biplanar Fluoroscopy, Transtibial Amputation, Pistoning, Elevated Vacuum Suspension