CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Symphonie Aqua SystemTM +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04141748
NCT04141748N/ACompleted

Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit

Northwestern University·interventional·Posted Oct 28, 2019·Updated Sep 19, 2024

In Brief

A clinical study evaluating Symphonie Aqua SystemTM and Hand Casting for Lower Limb Amputation. Completed, enrolled 80 participants across 3 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly, United States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 28, 2019
Enrollment StartSep 1, 2020
Primary CompletionSep 1, 2023
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 6.7 years ago

Interventions

Symphonie Aqua SystemTMdevice

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

Hand Castingprocedure

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