NCT04306796已完成不适用
3D Printed Made to Measure Splints for Hand Patients - Pilot Feasibility Study and Socioeconomic Evaluation
University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年8月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in patient comfort and satisfaction
研究概览
简要总结
This study aims to evaluate the feasibility and possible benefits of 3D-printed made to measure splints for postoperative or post-traumatic treatment in hand surgical patients (intervention group) in comparison to thermoplastic splints individually adjusted by occupational therapists (control group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patients presenting to the hand surgical department of the University Hospital Basel
- •Patients with hand trauma w/wo the need for hand surgery or patient with planned elective hand surgical intervention
- •Indication for immobilization of at least 4 weeks
- •Older than 18 years
- •Capable of consent
- •Informed Consent as documented by signature
排除标准
- •Open wounds with tissue loss
- •Injury with the need for external fixation
- •Younger than 18 years
- •Not capable of consent
- •Asymmetric deformity or loss of the contra-lateral hand
- •Documented hypersensitivity or allergy to Polylactic acid
- •Known or suspected non-compliance to agreed treatment measures and/or unexcused nonappearance to hospital appointments
- •Drug or alcohol abuse
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •Previous enrolment into the current study
结局指标
主要结局
Change in patient comfort and satisfaction
时间窗: at 6 weeks of immobilization during what is usually the concluding visit of treatment
questionnaire 3. that will be filled out by the Patient (scale 1-10 and answer text with qualitative assessment)
次要结局
未报告次要终点
研究者
研究点 (2)
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