Lower Limb AmputationNCT04141748
Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit
A study testing Symphonie Aqua SystemTM and Hand Casting in people with Lower Limb Amputation, run by Northwestern University at 3 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputation
- What is being tested?
- Symphonie Aqua SystemTM and Hand Casting
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Sep 2020to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral lower limb amputation (transtibial and transfemoral)
- current prosthesis users
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
NUPOC
Chicago, Illinois, 60611
Minneapolis VA Heath Care System
Minneapolis, Minnesota, 55417
About this study
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.
Read the 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.
- Conditions
- Lower Limb Amputation
- Being tested
- Symphonie Aqua SystemTM, Hand Casting
- Keywords
- shape capture, prosthetic sockets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symphonie Aqua SystemTMDevice
a water filled cylinder that can be pressurized around the residual limb to support body weight
Hand CastingProcedure or surgery
plaster of Paris or fiberglass bandages are wrapped around the residual limb
| Study group | Role | What they receive |
|---|---|---|
| Hand Casting | Active comparator | 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 Receives: Procedure: Hand Casting |
| standing hydrostatic pressure casting with a water cylinder | Active comparator | 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. Receives: Device: Symphonie Aqua SystemTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Socket Comfort Score
Score from 0-10, with 0 being the least comfortable socket and 10 being the most comfortable socket
Measured: at study completion, 1 month
Secondary outcomes (4)
Cast/Socket volume
digitized volume and shape of cast and socket
Measured: at every study visit, up to 1 month
Procedure time
Time to cast, rectify and fit the socket
Measured: at every study visit, 1 month
Socket Fit
checklist will be used to assess fit of socket
Measured: at study completion, 1 month
Socket preference
subject's preference for socket to continue wearing
Measured: at study completion, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start1 Sep 2020
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Limb AmputationStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, multi-center, assessor-blinded, cross-over study
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Minneapolis Veterans Affairs Medical Center, INAIL (Istituto Nazionale per L'Assicurazioni contro gli Infortune sul Lavoro), University of Washington
- Responsible party
- Principal investigator, Steven Gard, Northwestern University
- Investigators
- Steven Gard, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141748
- Sponsor's protocol ID
- W81XWH1910835
- Status last verified
- Sep 2024
- First submitted
- 21 Oct 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41270063
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit
- ClinicalTrials.gov ID
- NCT04141748
- Acronym / sponsor ID
- W81XWH1910835
- Conditions
- Lower Limb Amputation
- Keywords
- shape capture, prosthetic sockets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Minneapolis Veterans Affairs Medical Center, INAIL (Istituto Nazionale per L'Assicurazioni contro gli Infortune sul Lavoro), University of Washington
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, multi-center, assessor-blinded, cross-over study
| Arm | Type | Receives |
|---|---|---|
| Hand Casting | Active comparator | Procedure: Hand Castinghand 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 comparator | Device: Symphonie Aqua SystemTMhand 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- unilateral lower limb amputation (transtibial and transfemoral)
- current prosthesis users
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symphonie Aqua SystemTMa water filled cylinder that can be pressurized around the residual limb to support body weight | Device | standing hydrostatic pressure casting with a water cylinder |
| Hand Castingplaster of Paris or fiberglass bandages are wrapped around the residual limb | Procedure or surgery | Hand Casting |
Primary outcome
Socket Comfort Score
Time frame: at study completion, 1 month
Score from 0-10, with 0 being the least comfortable socket and 10 being the most comfortable socket
4 secondary outcomes
Cast/Socket volume
Time frame: at every study visit, up to 1 month
Procedure time
Time frame: at every study visit, 1 month
Socket Fit
Time frame: at study completion, 1 month
Socket preference
Time frame: at study completion, 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 41270063Fatone 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Lower Limb Amputation
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Impact of Footwear on Gait in Unilateral Transtibial Amputees
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Prosthetic Socket Fit Testing System
Amputation
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TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
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Amputation, Ultrasonography
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Gard, PhD principal investigator
Northwestern University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symphonie Aqua SystemTM and Hand Casting in people with Lower Limb Amputation, run by Northwestern University at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Socket Comfort Score (time frame: at study completion, 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04141748, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.