CTRI/2024/12/078482已完成Unknown
A Prospective, Single Arm, Post Market Clinical Follow-up (PMCF) Study to Evaluate the Safety and Performance of Distal Humerus Plate System Intended for Fracture Fixation
Auxein Medical Private Limited1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年12月25日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1. Evaluation of function outcome scores (MEPS and Quick DASH).
研究概览
简要总结
The proposed Post marketing clinical follow up study aims to assess the safety and performance of distal humerus plate system being manufactured by Auxein Medical Private Limited. A total of twenty patients of both gender with distal humerus fracture will be enrolled in the study, and will be followed up till one year post-operatively. The study includes assessment of functional outcome, pain scores, radiological evaluation of bone union, and recording and assessment of device associated adverse events.
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 distal humerus fractures/ intercondylar humerus fracture.
排除标准
- •Infection, local or systemic, acute or chronic inflammation at the operative site.
- •Patient with known history of metal allergy.
- •Mental illness or schizophrenic, which may cause patients to ignore the limitations and precautions of the implanted material leading to implants fracture and complication.
- •Patients having inadequate tissue coverage over the operative site.
- •Presence of marked or rapid bone absorption, metabolic bone disease, cancer, or any other tumorâ€like condition of the bone which may compromise fixation.
- •Female participant who is pregnant or planning pregnancy during the course of the study.
- •Chronic alcoholics, and smokers.
- •Any condition or anatomy that makes treatment with the distal humerus plate system infeasible.
- •Patients who are incarcerated or have pending incarceration.
结局指标
主要结局
1. Evaluation of function outcome scores (MEPS and Quick DASH).
时间窗: Three time points; 3, 6, and 12 months.
2. Improvement in pain score (VAS).
时间窗: Three time points; 3, 6, and 12 months.
次要结局
- 1. Radiological evaluation by X-ray radiographs to assess the mean time taken to achieve bone union.(2. Evaluation of any complications/adverse events associated with)
研究者
Dr Dinesh Chandra
Meerut Orthopaedics & Research Centre
研究点 (1)
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