Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit
1 other identifier
interventional
80
2 countries
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2020
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2019
CompletedFirst Posted
Study publicly available on registry
October 28, 2019
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedSeptember 19, 2024
September 1, 2024
3 years
October 21, 2019
September 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Socket Comfort Score
Score from 0-10, with 0 being the least comfortable socket and 10 being the most comfortable socket
at study completion, 1 month
Secondary Outcomes (4)
Cast/Socket volume
at every study visit, up to 1 month
Procedure time
at every study visit, 1 month
Socket Fit
at study completion, 1 month
Socket preference
at study completion, 1 month
Study Arms (2)
Hand Casting
ACTIVE COMPARATORhand 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
standing hydrostatic pressure casting with a water cylinder
ACTIVE COMPARATORhand 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.
Interventions
a water filled cylinder that can be pressurized around the residual limb to support body weight
plaster of Paris or fiberglass bandages are wrapped around the residual limb
Eligibility Criteria
You may qualify if:
- unilateral lower limb amputation (transtibial and transfemoral)
- current prosthesis users
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
NUPOC
Chicago, Illinois, 60611, United States
Minneapolis VA Heath Care System
Minneapolis, Minnesota, 55417, United States
INAIL
Bologna, Emilia-Romagna, 40139, Italy
Related Publications (1)
Fatone S, Gravely A, Cutti AG, Hansen AH, Gard SA; Residual Limb Shape Capture Group. Randomized crossover trial of hand and hydrostatic casting for custom lower limb prosthetic sockets: Assessing socket comfort and fabrication time. PLoS One. 2025 Nov 21;20(11):e0337185. doi: 10.1371/journal.pone.0337185. eCollection 2025.
PMID: 41270063DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Gard, PhD
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 21, 2019
First Posted
October 28, 2019
Study Start
September 1, 2020
Primary Completion
September 1, 2023
Study Completion
September 1, 2023
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will be shared after acceptance for publication of the main findings from the final dataset.
- 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.
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.