Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit: Northwestern University Prosthetics-Orthotics Center: Feinberg School of Medicine: Northwestern University
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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. Therefore the overall objective of this project 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. Aim 1: To compare the consistency of two residual limb shape capture techniques in persons with transtibial and transfemoral amputation. Aim 2: To compare the efficiency of two residual limb shape capture techniques in persons with transtibial and transfemoral amputation. Aim 3: To compare the outcomes of two residual limb shape capture techniques in persons with transtibial and transfemoral amputation. Study Design This will be a prospective, multi-site, assessor-blinded, randomized crossover comparative effectiveness clinical trial to assess initial socket fit and comfort achieved with two casting techniques: hand casting and standing hydrostatic pressure casting with a water cylinder. Subjects with lower limb amputation will act as their own controls. See Figure. Figure: Overview of the experimental approach with endpoints to be measured for each aim. Clinical Impact This study will show whether standing hydrostatic pressure casting using a water cylinder offers a consistent and efficient alternative to conventional hand casting for prosthetic socket fabrication that results in a more comfortable socket “right out the gate”. Such evidence is needed to support the adoption of new technologies for persons living life with a lower limb amputation. Related Information Cutti A, Osti G, Migliore G, Cardin D, Venturoli F, Verni G. (2018) Clinical Effectiveness of a Novel Hydrostatic Casting Method for Transfemoral Amputees: Results from the First 64 Patients. O&P News, October 31. Vigorso, le protesi per i reduci americani. Il resto del Carlino, Bologna, Italy, January 18, 2020. Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit This study is conducted as a Multi-Center Randomized Crossover Trial (RCT) and is registered with clinicaltrials.gov. Access the Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit protocol. Support NUPOC. 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