A Prospective, Open-label, Randomized, Clinical Trial of Light Cured Limb Orthosis - FlexiOH® as Definitive Cast for Immobilization of Forearm Fractures in Emergency Settings
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- 1.Average time required for the fracture to heal completely in all the arms at the end of treatment determined by X-rays.
研究概览
简要总结
TheClinical Investigation is intended to evaluate the efficacy and suitability of thedevice FlexiOH****® inpatients taking cast immobilization therapy for non-operative treatment offracture lower end radius and/or ulna in comparison with POP and fibreglass andalso evaluate the usability of device based on design characteristics withcompared to current standard and safety issues associated with the use of thedevice FlexiOH****®.
The clinical study will be conducted at 5 sites acrossIndia. Upto 300 subjects will be enrolled in the study.Enrolment in the studyis expected to take approximately 4 months. The total Duration of clinical investigationis expected to be approximately 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female aged 18 to 80 years (both inclusive) 2.Subjects with closed fracture of distal end of radius and/or Ulna not requiring internal or external fixation of the fracture belonging to following AO classification: AO CLASSIFICATIONS Distal radius i.Extraarticular ii.2R3A1 Radial styloid avulsion iii.2R3A2 Simple Distal Ulnar fracture i.2U3A1 Styloid process ii.2U3A2 Simple 3.Radiological features following above AO classification 4.Subjects able to provide written informed consent 5.Subjects able to comply with the study procedures.
排除标准
- •1.Presence of wound involving deeper tissues or requiring suturing 2.Ulceration or any skin conditions present at the wrist that may interfere with the study 3.Open wound along with fracture or fracture requiring internal fixation 4.Subjects scheduled for surgical management 5.Patients with other co morbid conditions, such as, osteomyelitis, severe dementia, or rheumatoid arthritis 6.Known skin allergy and skin diseases 7.Mentally challenged patients.
结局指标
主要结局
1.Average time required for the fracture to heal completely in all the arms at the end of treatment determined by X-rays.
时间窗: 6-8 weeks
a.X-ray features to diagnose /conclude that bone fracture has been healed.
时间窗: 6-8 weeks
3.Assessment of clinical efficacy scoring obtained by list of questionnaires compared between FlexiOH®, Fiberglass and POP.
时间窗: 6-8 weeks
2.Comparison of all three arms with respect to indices.i.e.
时间窗: 6-8 weeks
•Cast index
时间窗: 6-8 weeks
•Gap index
时间窗: 6-8 weeks
4.Assessment of usability scoring compared between FlexiOH® Fiberglass and POP
时间窗: 6-8 weeks
•Padding index
时间窗: 6-8 weeks
次要结局
- 1.Incidence of any of the following complication(i.Development of swelling)