Clinical Evaluation of Cast21 Short Arm Product During Treatment of Distal Radial or Distal Ulnar Fractures
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Range of Motion (standard of care)
研究概览
简要总结
The primary objective of this study will be the collection of preliminary clinical evidence to indicate that Cast21 Short Arm Product is no worse than the current standard of care arm immobilization devices in pediatric patients.
A secondary objective will be to characterize the clinician and patient experience with the Cast21 Short Arm Product.
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
- 3 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Demographic characteristics: all persons ages 3 and above, regardless of the race and sex will be eligible to participate in this study
- •Medical condition: participants must present with a closed, nondisplaced, or minimally displaced distal radius fracture and/or distal ulnar fracture that does not require a bone reduction procedure within 10 days from the date of injury
- •Sizing: participants eligible for the Cast21 Short Arm Product must undergo sizing conducted by the clinical staff to ensure fit into one of the products (sizes XS-L)
排除标准
- •Participants requiring a surgical intervention
- •Participants with moderately displaced or angulated fractures or fractures requiring a bone reduction procedure.
- •Participants with a known history of bone diseases e.g. osteogenesis imperfecta or other pathologic bone conditions
- •Participants with pathologic fractures e.g., presence of bone cyst
- •Participants who smoke
- •Participants with pre-existing skin infection or condition of the lower arm (participants exhibiting only minor skin abrasions, lacerations, or skin condition might be eligible per clinical investigator's discretion)
研究组 & 干预措施
Cast21 Short Arm Product
干预措施: Cast or brace alternative (Device)
结局指标
主要结局
Range of Motion (standard of care)
时间窗: At treatment completion, an average of 4 weeks
Clinicians will asses patients for a binary determination of Full Range of Motion or Limited Range of Motion
Clinical determination of healing (standard of care)
时间窗: At treatment completion, an average of 4 weeks
A binary determination of healing after the intervention will be asserted by the clinician
次要结局
- Physical Therapy Referral(At treatment completion, an average of 4 weeks)
- Patient Reported Outcomes - Pain(Before treatment (0 Days) and at treatment completion, an average of 4 weeks)
- Patient Reported Outcomes - Satisfaction(At treatment completion, an average of 4 weeks)