Comparison of Socket Geometry and Clinical Outcomes Between Manually- and Digitally-designed Prosthetic Sockets for Lower-limb Amputees: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Patient retention rates
研究概览
简要总结
The most important aspect of a lower-limb prosthesis is the socket as the interface between the human and the mechanical prosthetic system. Proper fit of the socket to the residual limb is a critical factor in determining comfort, suspension, energy expenditure and ultimately the functional efficiency of the remaining prosthesis. Patients may not wear their prosthesis if they find the socket uncomfortable.
Traditional manufacturing of prosthetic sockets is a high-skill process involving several stages. Capturing the shape of the residual limb and modifying the mould is performed with a manual, hands-on approach. This leads to inconsistencies between clinicians, and increases the likelihood of human error. There is opportunity to improve this process with advanced computer-aided design (CAD) and manufacturing (CAM). 3D printing can be leveraged for its ability to effortlessly manufacture one-off, complex and organic shapes, such as prosthetic sockets. However, the digital method removes the tactile feedback that the clinician generally benefits from when manually designing the socket, thus leading to some uncertainty in how they are modifying the socket. Moreover, the difference in the learning curve may cause inconsistencies in modifications made by different clinicians.
While clinicians may be hesitant in their knowledge-transfer from a manual to digital method, sockets designed using CAD still produce successful outcomes. To facilitate wider-spread adoption of 3D printing as a standard tool in the clinic, more research is needed to better understand how the digital design process affects the geometry of the socket, and how this affects clinical outcomes for amputees.
The investigators hypothesize that (1) digitally-designed sockets and manually-designed sockets will have geometric differences, (2) the digitally-designed socket will result in better clinical outcomes compared to manually-designed sockets, and (3) improved clinical outcomes will correlate to geometric differences centred on particular regions of the socket. However, a feasibility study is needed to inform an effective protocol. This feasibility study aims to explore socket geometries and prosthetic outcomes compared between manually-designed and digitally-designed devices for lower-limb amputees. Findings will help in improving the current 3D printing techniques and exploring outcomes for the users.
详细描述
This crossover case-control feasibility study aims to explore socket geometries and prosthetic outcomes compared between manually-designed and digitally-designed devices for lower-limb amputees. Feasibility and outcome measures will be measured at three major stages of routine prosthetic care, namely the socket fabrication, socket fitting, and functional testing.
Socket Fabrication:
Participants will be measured for the prosthetic device through (1) manual casting using Plaster of Paris bandages and (2) scanning using a 3D scanner (Artec Eva, Artec 3D, Luxembourg). The patient's residual limb soft tissue density will also be measured using a standard gauge (Fowler depth gage, Fowler Co., Inc., Massachusetts, USA) on certain landmarks: medial flare, distal end, lateral, popliteal region, distal tibia. The clinician will manually modify the positive plaster cast (herein, the M-socket) and digitally modify the scanned impression (herein, the AD-socket) using OMEGA software (OMEGA software, WillowWood Global LLC, Ohio, USA). The M-socket positive cast will be digitized by scanning the cast and exporting it to OMEGA. This scanned M-socket file and the CAD-socket file will each be 3D printed (Stratasys F370, Stratasys Ltd., Minnesota, USA) in nylon-based thermoplastic. Conventionally, the socket is manufactured by draping thermoplastic over a mold, but for this study, both sockets will be 3D printed. The two 3D-printed sockets will then be reinforced and connected to its corresponding component adapters using fiberglass and resin materials, as is done during current standard of care. To eliminate confounding, the same suspension and components will be used. Subjects will be given a patient experience survey to score their experience with each shape capturing process. The survey will be administered by a research assistant using a face-to-face interview technique before they are fit with the sockets.
Socket Fitting:
Both sockets will be fitted to the subject and immediate Socket Comfort Score will be recorded through an analogue visual scale, and will be recorded for every day that the patient wears each device. The immediate socket fit will be recorded by the number of filler sock plys needed to be added in the socket. Also, changes made to the sockets by the clinician (e.g., spot relieving) will be recorded. Subjects will continue therapy using the socket that is more comfortable and fits better, based on both the subject's judgment and the judgment of their clinician. If the subject finds both sockets as equally comfortable, he/she will get to choose the preferred socket to continue with for therapy. A healthcare provider will assist in the selection, should the patient request it. The subjects will be given 2 days to acclimate to the selected socket and will be retested for Socket Comfort Score once a day during the subject's therapy sessions, and tested for function one day before discharge (defined below).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In-patient adults (18 years and older)
- •Unilateral transtibial amputation
- •Eligible to receive a preparatory prosthetic device
- •Able to communicate in English orally and in writing
- •Able to tolerate participating in an additional 30- minute 3D scanning session
排除标准
- •Presentation of significant cognitive impairment
- •History of epilepsy
- •On dialysis at any point of the duration of the study
结局指标
主要结局
Patient retention rates
时间窗: Through study completion, an average of 1 year
Patient drop-out rate will be tracked throughout the study period.
Adherence to protocol
时间窗: Through study completion, an average of 1 year
Adherence to protocol steps (i.e., casting, CAD, 3D printing, or functional testing protocols) will be tracked throughout the study period and a standardized checklist of procedures will be kept to measure the rate at which procedures are implemented as intended for fidelity assessment.
Patient recruitment rates
时间窗: Through study completion, an average of 1 year
The number of eligible vs. recruited patients will be tracked throughout the study period.
次要结局
- Socket geometric differences(Through study completion, an average of 1 year)
- Socket comfort score change(Through study completion, an average of 1 year)
- Two-minute walk test(Performed one day prior to discharge from West Park.)
- L-test(Through study completion, an average of 1 year)