Digital Weight Bearing Shape Capture Socket Technology

NCT ID: NCT05749952

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-06
• Study Completion Date: 2023-07-18

Brief Summary

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.

Detailed 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.

Conditions

Amputation; Prosthesis User; Residual Limbs

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Symphonie Aqua System - Non-Digital (Socket B)

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

Group Type: EXPERIMENTAL

Symphonie Aqua Digital System mediated sh

Intervention Type: DEVICE

For socket fabrication, the shape capturing is done in full weight bearing.

Standard of Care (SoC)

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

Group Type: ACTIVE_COMPARATOR

Symphonie Aqua Digital System mediated sh

Intervention Type: DEVICE

For socket fabrication, the shape capturing is done in full weight bearing.

Interventions

Symphonie Aqua Digital System mediated sh

For socket fabrication, the shape capturing is done in full weight bearing.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sashwati Roy

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sashwati Roy, PhD.

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

15478

Identifier Type: -

Identifier Source: org_study_id