A Clinical Comparison of Patient-specific 3D Printed Splints Versus Conventional Splints in the Treatment of Distal Radius Fractures.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- D-QUEST
研究概览
简要总结
The goal of this clinical trial is to assess patient reported outcome measures of adult patients who are diagnosed with a distal radius fracture and treated with a patient-specific 3D printed splint as compared to a control cohort.
Patients receive routine immobilization procedure with a patient-specific 3D printed splint instead of the use of a conventional forearm splint after one week of conventional immobilization.
The main study parameters are patient reported outcome measures related to comfort and satisfaction of the medical aid. This will be measured qualitatively with a semi-structured interview and quantitively using questionnaires.
详细描述
Distal radius fracture (DRF) is a very common injury of the upper extremity. Yearly, over 45,000 patients visit the outpatient clinic with a DRF in the Netherlands. One third of these fractures are non-displaced and two thirds are displaced fractures. The conservative treatment of DRFs includes immobilization of the injured extremity using a conventional forearm cast. These casts do cause all sorts of discomfort during wear and impose life-style restrictions on the wearer. Examples are irritation and itching of the skin, pain from pressure points and inability to shower or swim without a protective sleeve. Emergent three-dimensional (3D) technology enables patient-specific splint design and fabrication. These splints are custom made to accurately fit the individual patient. The material of 3D printed splints is considered lightweight. Moreover, 3D splint design allows an open structure resulting in more ventilation, offering better hygiene and the possibility for wound control. The production of 3D splints can be accomplished with several hardware and software combination. The production process is similar overall and requires several steps. First image data with 3D spatial information of the limb is captured with either a 3D scanner or medical imaging device. The design of the 3D printed splint is further developed using a software application. The 3D splints design data is then exported, and the physical splint is printed using a 3D printer. Depending on material and device characteristics, postprocessing steps are required. The splint may require removal of support, curing and smoothing. If applicable, a closure mechanism is applied.
Currently most implementations of custom made 3D printed splints happen within the framework of case series or feasibility studies. Some previous studies have described on clinical tests from patients with promising results. However, studies are heterogenous in the use of hardware, software, 3D splint design, print materials, fabrication time and costs. Moreover, clinical comparison with conventional interventions remain scare. Therefore, it is challenging to determine the impact of 3D printed splints intervention on the patient with injuries .
The goal of this clinical trial is to assess patient reported outcome measures of adult patients who are diagnosed with a DRF and treated with a patient- specific 3D printed splint as compared to a control cohort. The secondary objectives are:
- To define whether treatment of 3D printed splints of DRF's result in the same clinical outcomes compared to treatment with standard plaster cast .
- To investigate the safety of 3D printed splint treatment.
- To generate hypothesis which individual characteristics might be used to determine which patients can benefit most from 3D printed splint treatment.
- To investigate barriers and facilitators to implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16 years or older
- •Admitted to the emergency department or plaster room with a DRF
- •Non-operative treatment with cast immobilization
- •Written informed consent
- •Patients must be able to follow the study protocol
排除标准
- •Operative treatment
- •Open fractures
- •History of surgically treated wrist fracture on the currently injured side within the last year (≤ 1 year)
- •Unable to wear conventional forearm splint due to medical condition, known allergies or other reasons
- •(partially) paralysis of the affected arm
- •DRF older than two weeks
研究组 & 干预措施
3DxSPLINT
干预措施: 3DxSPLINT (Device)
结局指标
主要结局
D-QUEST
时间窗: three to five weeks post injury
Instrument for measuring client satisfaction with a medical device. D-QUEST is a Dutch version of the Quebec User Evalutation of Satisfaction with assistive Technology.
Semi structured interview
时间窗: three to five weeks post injury
Patient reported outcome measrues related to comfort and satisfaction of the medical aid. Issures discussed:limitations daily life, cosmetic look and local complicaitons.
CSD-OPUS
时间窗: three to five weeks post injury
The Orthotics and Prosthetics User's Survey on the Satisfaction with Devices.
EQ-5D VAS
时间窗: three to five weeks post injury
Rates the overall health of a patient.
次要结局
- PRWE(Approximately, one week, three to five weeks and 3 months post injury.)
- Union rate(One week to three months post injury)
- Complications(three months post injury.)
- Barriers to implementation(one week to three months post injury)
- Safety outcomes(one week to three months post injury)