Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM

US Department of Veterans Affairs (VA)

Status: Completed

Conditions: Traumatic Amputation of Arm

Treatments: Other: Skeletal Stabilization

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01546675

A9227-P

Details and patient eligibility

About

The purpose of this pilot study was to conduct a head-to-head comparison of two designs for transhumeral level upper limb prosthetic sockets: a traditional socket design and a socket design hypothesized to provide greater skeletal stabilization. The investigators comparisons included assessments of patient comfort and satisfaction with fit, as well as dynamic kinematic assessment using X-Ray Reconstruction of Moving Morphology (XROMM) a novel high-speed, high-resolution, bi-plane video radiography system.

Full description

In the past decade, advances in upper limb socket design and technology have been proposed to increase comfort and decrease perceived weight of the prosthesis. There have been no scientific studies to date that have evaluated the benefits of these designs, and thus no evidence to support use of one type of prosthetic socket design over another. Thus, the overall purpose of this pilot study was to conduct a head-to-head comparison of two designs for transhumeral level upper limb prosthetic sockets: a traditional socket design and a socket design hypothesized to provide greater skeletal stabilization.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female transhumeral amputees, 18 years or older of any ethnicity, who are current prosthetic users.

Exclusion criteria

• Subjects with frozen shoulder of the residual side, and/or severely limited active range of motion of the shoulder joint of the residual limb
• Inability to tolerate wearing of a prosthetic socket
• Mental impairment that renders a subject unable to comply with the study
• Skin conditions such as burns or poor skin coverage as well as those with severe contractures that prevent prior prosthetic wear
• Any electrically controlled medical device including pacemaker, implanted defibrillator or drug pumps
• Neuropathy, uncontrolled diabetes, receiving dialysis
• Any other significant comorbidity which would interfere with the study
• Severe circulatory problems including peripheral vascular disease and pitting edema will be excluded
• 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 in the near future

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Traditional 1, Skeletal Stabilization 2

Active Comparator group

Description:

Subjects using the Traditional Socket and socket hypothesized to increase skeletal stabilization in a case cross-over design. The intervention is the socket designed to increase skeletal stabilization.

Treatment:

Other: Skeletal Stabilization

Skeletal Stabilization 1, Traditional 2

Experimental group

Description:

Subjects using the socket hypothesized to increase skeletal stabilization and Traditional Socket and in a case cross-over design. The intervention is the socket designed to increase skeletal stabilization.

Treatment:

Other: Skeletal Stabilization