Digital Weight Bearing Shape Capture Socket Technology (DWB)

Indiana University

Status: Completed

Conditions: Residual Limbs; Amputation; Prosthesis User

Treatments: Device: Symphonie Aqua Digital System mediated sh

Study type: Interventional

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

Identifiers

NCT05749952

15478

Details and patient eligibility

About

The study will determine if Symphonie Aqua Digital System, a new method of socket creation, in a weight-bearing environment, may produce more successful fitting and comfortability & functional outcomes than traditional sockets (non-weight bearing scanning). Additionally, the study will determine if a well-fitting socket will positively impact the overall health of amputee residual limb.

Full description

This study will compare the use of Symphonie Aqua Digital System, which is a new way to create a socket for prosthetics, to the current method that is generally used to create sockets. The study will look at the differences in comfort and fit between the Symphonie Aqua Digital System and the current standard of care (SOC).

The study will determine if Symphonie Aqua Digital System, a new method of socket creation, in a weight-bearing environment, may produce more successful fitting and comfortability & functional outcomes than traditional sockets (non-weight bearing scanning). Additionally, the study will determine if a well-fitting socket will positively impact the overall health of amputee residual limb.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages 18 and above
• Unilateral trans-tibial amputees
• Ambulate at a K3 level or higher
• At least 3 months post-amputation per physician discretion
• Trans-tibial limb length greater than 4.5 inches in length
• Able to follow directions and independently give informed consent
• Must be able to ambulate without assistance

Exclusion criteria

• Age < 18 years
• Conditions that prevent wearing a prosthetic socket
• Soc Socket made with weight bearing system
• Cognitive deficits or mental health problems that would limit ability to consent and participate fully in the study protocol
• Women who are pregnant or who plan to become pregnant in the near future
• Weight > 280 lbs

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Symphonie Aqua System - Non-Digital (Socket B)

Experimental group

Description:

A digital weight bearing test socket where shape capturing is done in full weight bearing

Treatment:

Device: Symphonie Aqua Digital System mediated sh

Standard of Care (SoC)

Active Comparator group

Description:

This is standard of care socket design where sockets are fabricated in non-weight bearing position

Treatment:

Device: Symphonie Aqua Digital System mediated sh