Symphonie Aqua SystemTM
Devicea water filled cylinder that can be pressurized around the residual limb to support body weight
NCT Number: NCT04141748
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
INAIL, Bologna, Emilia-Romagna, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: at every study visit, up to 1 month
digitized volume and shape of cast and socket
Time frame: at every study visit, 1 month
Time to cast, rectify and fit the socket
Time frame: at study completion, 1 month
checklist will be used to assess fit of socket
Time frame: at study completion, 1 month
subject's preference for socket to continue wearing
Northwestern University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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