Clinical Evaluation of Direct Manufactured Prosthetic Sockets
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting
研究概览
简要总结
The purpose of this study is to evaluate a new prosthetic socket construction technique in order to improve the quality of care to lower extremity amputees.
详细描述
Many members of the Armed Forces and civilians are in need of prosthetic devices due to amputations resulting from gunshots, bombings, vehicular accidents, and other traumas. As the number of amputees increase at a high rate, the limited number of certified prosthetists is finding it harder to satisfy the patient demand. Therefore, the overall goal is to provide the Orthopedic & Prosthetic (O&P) industry with a tool that accommodates the increasing prosthetist to patient ratio and still provide acceptable product quality.
The practice of creating prosthetic sockets by the plaster-casting of amputees' residual limbs has been around for decades but continues to be the most commonly used method for the shape capture, modification and fabrication of prosthetic sockets. Using this traditional plaster-casting approach has many limitations that can now be overcome through the use of technology.
With the advancing developments in Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technologies over the past ten years, it is now possible to completely replace the plaster-casting approach with handheld, portable scanners.
While this current CAD/CAM approach certainly creates substantial efficiencies in the clinical aspects of creating the prosthetic socket, the actual manufacturing of the prosthetic device continues to rely on the use of a positive model and a lengthy manual fabrication process.
The continuing development of direct manufacturing technologies may serve as the final piece in the effective utilization of CAD/CAM in the care of prosthetic and orthotic patients. Direct manufacturing provides a means to quantify alterations and accurately reproduce prosthetic sockets. Additionally, direct manufacturing has the potential to reduce time, cost, and waste, as a result improve the quality and care ability to patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Be a lower extremity amputee longer than one year
- •Be a consenting adult (at least 18 years or age or older)
- •Albe to ambulate in current prosthesis without an aid (can, crutches or walker) for 30 minutes without rest
- •Currently using a liner with prosthesis
- •Be available during regular business hours for appointments
排除标准
- •An inability to give informed consent
- •Presence of any sores, lacerations or rashes on the residual limb
- •Impaired contra lateral foot
- •Poor distal sensation
研究组 & 干预措施
Traditional Socket First, then DM Socket
Initial fitting of a traditional diagnostic prosthetic socket in first intervention period and initial fitting of a direct manufactured prosthetic socket in the second intervention period
干预措施: Traditional fabricated prosthetic socket (Device)
Traditional Socket First, then DM Socket
Initial fitting of a traditional diagnostic prosthetic socket in first intervention period and initial fitting of a direct manufactured prosthetic socket in the second intervention period
干预措施: Direct manufactured (DM) prosthetic socket (Device)
DM Socket First, then Traditional Socket
Initial fitting of a direct manufactured prosthetic socket in first intervention period and initial fitting of a traditional diagnostic prosthetic socket in the second intervention period
干预措施: Traditional fabricated prosthetic socket (Device)
DM Socket First, then Traditional Socket
Initial fitting of a direct manufactured prosthetic socket in first intervention period and initial fitting of a traditional diagnostic prosthetic socket in the second intervention period
干预措施: Direct manufactured (DM) prosthetic socket (Device)
结局指标
主要结局
Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting
时间窗: Within the first 4-6 hrs
The Hanspal SCS assesses participant socket comfort on a continuous scale from 0 (most uncomfortable) to 10 (most comfortable)
次要结局
- Participant Socket Preference After Initial Fitting(Within the first 4-6 hours)
- Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket(3 months)