- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04141748
Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit
December 7, 2023 updated by: Steven Gard, Northwestern University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
One of the most important components of restoring function in persons with lower limb amputation is the precise fitting of the prosthetic socket to the residual limb.
However, this is challenging because the residual limb is dynamic in shape and volume.
Additionally, prosthetic socket fabrication processes influence socket fit.
These processes typically consist of residual limb shape capture, positive mold rectification, initial diagnostic socket fitting, and definitive prosthesis delivery.
The most prevalent residual limb shape capture method involves a negative wrap cast in a non-weight bearing position and manual manipulation of the cast to conform to the residual limb shape.
With this technique it is challenging to accurately capture the bony contours and distribute pressure evenly around the residual limb.
To improve shape capture, techniques that rely less on manual manipulation by the prosthetist, such as standing hydrostatic pressure casting with a water cylinder have been developed.
Given the use of physics to shape the residual limb, it has been proposed that pressure casting results in better fitting and more comfortable sockets, however this has not yet been demonstrated.
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 Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stefania Fatone, PhD
- Phone Number: 2066857918
- Email: sfaton@uw.edu
Study Locations
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italy, 40139
- INAIL
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-
-
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Illinois
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Chicago, Illinois, United States, 60611
- NUPOC
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Minnesota
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Minneapolis, Minnesota, United States, 55417
- Minneapolis VA Heath Care System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- unilateral lower limb amputation (transtibial and transfemoral)
- current prosthesis users
Exclusion Criteria:
- poor residual limb sensation
- a superficial neuroma that is painful to pressure
- an open sore on the residual limb
- a residual limb circumference or body weight that exceeds the size or weight limits of the Symphonie Aqua SystemTM (i.e., >58cm and 170kg for persons with transtibial amputation and >78cm and 170kg for persons with transfemoral amputation
- persons who are unable to stand for the 4-6 minutes required for casting (e.g. persons with bilateral amputations).
- persons with new amputations (i.e., have been an amputee for less than 1 year)
- persons with transfemoral amputation who have a known silicone allergy or a femur length less than 5 inches
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Hand Casting
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
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plaster of Paris or fiberglass bandages are wrapped around the residual limb
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Active Comparator: standing hydrostatic pressure casting with a water cylinder
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.
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a water filled cylinder that can be pressurized around the residual limb to support body weight
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Socket Comfort Score
Time Frame: at study completion, 1 month
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Score from 0-10, with 0 being the least comfortable socket and 10 being the most comfortable socket
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at study completion, 1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cast/Socket volume
Time Frame: at every study visit, up to 1 month
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digitized volume and shape of cast and socket
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at every study visit, up to 1 month
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Procedure time
Time Frame: at every study visit, 1 month
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Time to cast, rectify and fit the socket
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at every study visit, 1 month
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Socket Fit
Time Frame: at study completion, 1 month
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checklist will be used to assess fit of socket
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at study completion, 1 month
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Socket preference
Time Frame: at study completion, 1 month
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subject's preference for socket to continue wearing
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at study completion, 1 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Steven Gard, PhD, Northwestern University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Actual)
September 1, 2023
Study Completion (Actual)
September 1, 2023
Study Registration Dates
First Submitted
October 21, 2019
First Submitted That Met QC Criteria
October 25, 2019
First Posted (Actual)
October 28, 2019
Study Record Updates
Last Update Posted (Estimated)
December 11, 2023
Last Update Submitted That Met QC Criteria
December 7, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- W81XWH1910835
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data generated by the funded research will be made available to the research community and to the public under the auspices of the PI.
Prior to sharing, data will be de-identified and redacted to reduce the risk of subject identification.
IPD Sharing Time Frame
Data will be shared after acceptance for publication of the main findings from the final dataset.
IPD Sharing Access Criteria
The PI will share data upon request with anyone via a unique link to a file or folder within Northwestern Box.
A data-sharing agreement will be used to ensure that the data is only used for the purpose described, users acknowledge the data source in any use of the data, agree to provide the PI with copies of any presentation or publication that uses the data, prohibit sharing of the data with others without those parties having their own data use agreement, and prohibit manipulation of data for the purposes of identifying subjects.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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