Evaluation of Effectiveness between Manual data collection and mobile Application Based Data Collection for Infective non-union of long bone of Lower Limb Managed with Ilizarov Ring Fixation Using ASAMI Scoring System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The primary outcome is to evaluate the accuracy and efficiency of data collection for functional and radiological outcomes in patients with infective non-union of long bones treated with Ilizarov ring fixation. The study will compare mobile app-based data collection with the manual method using ASAMI scoring to assess data entry time, accuracy, and completeness, aiming to improve efficiency and reduce errors.
研究概览
简要总结
This study aims to compare the effectiveness of manual data collection and mobile application-based data collection in assessing functional and radiological outcomes of infective non-union of long bones of the lower limb managed with Ilizarov ring fixation. The outcomes will be evaluated using the ASAMI (Association for the Study and Application of Methods of Ilizarov) scoring system. The primary objective is to determine the accuracy, efficiency, and completeness of data collected through both methods. Secondary objectives include assessing functional recovery, radiological healing, user satisfaction, time efficiency, and error rates in data collection. Patients will be followed up for 6 months, with data collected at baseline, 1 month, 3 months, and 6 months. The study aims to provide insights into the feasibility and advantages of mobile application-based data collection in clinical research
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 24.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of surgicalable age who have extra-articular tibial or femoral infective non-union and who consent to treatment and follow-up.
排除标准
- 未提供
结局指标
主要结局
The primary outcome is to evaluate the accuracy and efficiency of data collection for functional and radiological outcomes in patients with infective non-union of long bones treated with Ilizarov ring fixation. The study will compare mobile app-based data collection with the manual method using ASAMI scoring to assess data entry time, accuracy, and completeness, aiming to improve efficiency and reduce errors.
时间窗: The assessments will be conducted at 1 month, 3 months, 6 months, and 1 year post-intervention.
次要结局
- The secondary outcomes include several aspects. First, patient outcomes will be compared between the two groups based on functional recovery & radiological healing, assessed using the ASAMI scoring system over the 6-month study period. Second, user satisfaction among healthcare professionals regarding the ease of use & effectiveness of the mobile application versus manual methods will be assessed through a Likert scale-based feedback questionnaire at the end of the study. Third, data management metrics such as the time taken for data entry, retrieval, & analysis will be compared between the two methods using recorded time logs. Finally, the completeness of datasets & error rates in data collection will be evaluated by auditing both methods for missing or incorrect entries at the end of the study. These outcomes will provide a comprehensive understanding of the effectiveness & feasibility of mobile application-based data collection in clinical research.(1 month,3 month,6 month,1 year)
研究者
Obli Prakash PC
Saveetha medical college and hospital.