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Procedure

Prosthetic Socket Casting Methods for Lower Limb Amputation

N/A
Waitlist Available
Led By Stefania Fatone, PhD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at study completion, 1 month
Awards & highlights

Study Summary

This trial is comparing two methods of creating a socket for a lower limb prosthetic - hand casting and standing hydrostatic pressure casting. The hypothesis is that the latter will lead to improved initial socket fit and comfort.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study completion, 1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and at study completion, 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Socket Comfort Score
Secondary outcome measures
Cast/Socket volume
Procedure time
Socket Fit
+1 more

Trial Design

2Treatment groups
Active Control
Group I: standing hydrostatic pressure casting with a water cylinderActive Control1 Intervention
hand cast will be taken using a circumferential plaster of Paris wrap of the residual limb with the subject in a seated position. The residual limb is then placed into the Symphonie Aqua System while in a weight bearing standing position.
Group II: Hand CastingActive Control1 Intervention
hand cast will be taken using a circumferential plaster of Paris or fiber glass wrap of the residual limb with the subject in a seated position

Find a Location

Who is running the clinical trial?

INAIL (Istituto Nazionale per L'Assicurazioni contro gli Infortune sul Lavoro)UNKNOWN
University of WashingtonOTHER
1,738 Previous Clinical Trials
1,844,271 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,151 Total Patients Enrolled

Media Library

Hand Casting (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04141748 — N/A
Lower Limb Amputation Research Study Groups: standing hydrostatic pressure casting with a water cylinder, Hand Casting
Lower Limb Amputation Clinical Trial 2023: Hand Casting Highlights & Side Effects. Trial Name: NCT04141748 — N/A
Hand Casting (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04141748 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people with the relevant medical condition able to sign up for this trial today?

"Yes, this information is accurate according to the listing on clinicaltrials.gov. The posting date was September 1st, 2020 and the most recent update was on August 23rd, 2022."

Answered by AI

What is the maximum sample size for this research project?

"The listing on clinicaltrials.gov verifies that this study is looking for participants as of 8/23/2022. The trial was first established on 9/1/2020. They need a total of 90 patients from 2 different locations."

Answered by AI

Who else is applying?

What state do they live in?
South Dakota
New Jersey
How old are they?
18 - 65
What site did they apply to?
NUPOC
Minneapolis VA Heath Care System
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit
Steven Gard 2020. "Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04141748.
~17 spots leftby Apr 2025
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