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Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit

NCT04141748 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-09-19

No results posted yet for this study

Summary

The overall objective is to compare hand casting to standing hydrostatic pressure casting using a water cylinder in persons with lower limb amputation. Our overall hypothesis is that standing hydrostatic pressure casting with a water cylinder will lead to more consistent and efficient residual limb shape capture and improved initial socket fit and comfort compared to hand casting.

Conditions

  • Lower Limb Amputation

Interventions

DEVICE

Symphonie Aqua SystemTM

a water filled cylinder that can be pressurized around the residual limb to support body weight

PROCEDURE

Hand Casting

plaster of Paris or fiberglass bandages are wrapped around the residual limb

Sponsors & Collaborators

  • Minneapolis Veterans Affairs Medical Center

    collaborator FED

  • INAIL (Istituto Nazionale per L'Assicurazioni contro gli Infortune sul Lavoro)

    collaborator UNKNOWN

  • University of Washington

    collaborator OTHER

  • Northwestern University

    lead OTHER

Principal Investigators

  • Steven Gard, PhD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2023-09-01
Completion
2023-09-01

Countries

  • United States
  • Italy

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04141748 on ClinicalTrials.gov