A Prospective, Single Arm, Post Market Clinical Follow-up (PMCF) Study to Evaluate the Safety and Performance of Humerus Nailing System intended for Fracture Fixation
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1. Radiological Evaluation by X-ray radiographs to calculate mean time to achieve bone fusion and deformity correction or stabilization.
研究概览
简要总结
Humerus nailing system is intended to provide fixation to diaphyseal fractures of the humeral shaft, fractures of the proximal humerus, proximal humeral fractures with diaphyseal extension and impending pathologic fractures. As a manufacturer, Auxein Medical Pvt Ltd has planned to conduct a Post-marketing clinical follow-up (PMCF) study following the CE marking of the device (Humerus Nailing System) marketed for its intended use and aims to verify the clinical performance and safety of the implant. The study involves one year post-operative follow-up to update the clinical performance and outcome of our device. This PMCF is required by the regulatory authorities for all medical device implants that do not have medium to long-term clinical evidence available at the time of gaining approval to market.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients presenting to Orthopaedic emergency/ OPD with Humerus shaft fracture will be included in the study.
排除标准
- •Infection, local or Systemic Acute or Chronic Inflammation to the operative site.
- •Subjects with a disease entity or condition that could hindered bone healing and create unacceptable risk of fixation failure complications such as known active cancer, neuromuscular disorder etc.
- •In case subject has inadequate tissue coverage of the operative site.
- •Subjects with Symptomatic Arthritis.
- •Subjects with Suspected or documented metal allergy or intolerance.
- •Subjects with substance abuse/alcohol issues.
- •Subjects who are incarcerated or have pending incarceration.
- •Female participant who is pregnant or planning pregnancy during the course of the study.
- •Any patient unwilling to cooperate with the post-operative instructions.
- •Compromised vascularity that would inhibit adequate blood supply to the fracture or the operative site.
- •Bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation of the devices.
- •Implant utilization that would interfere with anatomical structures or physiological performance.
结局指标
主要结局
1. Radiological Evaluation by X-ray radiographs to calculate mean time to achieve bone fusion and deformity correction or stabilization.
时间窗: Follwo up at 6 week, 3 month, 6 month, and 12 month
2. Quality of movement in arm and shoulder by calculating DASH score.
时间窗: Follwo up at 6 week, 3 month, 6 month, and 12 month
次要结局
- 1. Analyzing Visual analogue score (VAS) for pain assessment.(2. Any adverse event or serious adverse event during follow up, especially the one mentioned in the Product Description.)
研究者
Dr Mahipatsinh Parmar
Hi-tech Multispeciality Hospital