Functional Outcome of Surgical Management of Intra-articular Fractures of Distal Humerus in Adults
试验速览
- 阶段
- Phase 3 4
- 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 the functional assessment of the distal humerus following surgical management.
研究概览
简要总结
This prospective case series study aims to assess the functional outcomes of surgical management for intra-articular fractures of the distal humerus in adults. Conducted at Acharya Vinobha Bhave Rural Hospital Sawangi (Meghe) Wardha, the study will include 30 patients aged over 18 years who have sustained these fractures and consented to surgery. Exclusion criteria ensure patient safety by omitting individuals unfit for surgery, those with extreme osteoporosis, open fractures, or pathological fractures. The intervention involves open reduction internal fixation (ORIF), with pre-operative evaluation, trans-olecranon approach during surgery, and post-operative early mobilization. The primary outcomes will be measured using MAYO and DASH scoring at 6 weeks, 3 months, and 6 months to evaluate pain, fracture union, and functional outcomes. Secondary outcomes include assessing pain levels, complications, and overall patient satisfaction at these time points. The study will utilize statistical methods to confirm the significance of the results, contributing valuable insights into the efficacy of ORIF for distal humerus fractures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •The study includes patients who meet specific criteria to ensure the relevance and effectiveness of the intervention.
- •Firstly, all patients with intra-articular fractures of the distal humerus are considered eligible for the study.
- •This inclusion is crucial as it focuses on a particular type of fracture that the intervention aims to treat.
- •Secondly, the study targets adults, specifically those aged more than 18 years, to ensure that the results are applicable to the adult population who typically undergo this type of surgery.
- •Lastly, only those patients who provide informed consent for the surgical procedure are included, ensuring that participants are willing and informed about the surgical intervention and its implications.
排除标准
- •To ensure safety and validity, patients unfit for surgery, with extreme osteoporosis, open fractures, or pathological fractures are excluded to avoid complications, negative impacts on outcomes, and confounding results.
结局指标
主要结局
The primary outcome is the functional assessment of the distal humerus following surgical management.
时间窗: 6 WEEKS , 3 MONTHS AND 6 MONTHS
次要结局
- Assessment of pain levels, complications, and overall patient satisfaction post-surgery.(6 weeks: Evaluate pain levels and early complications.)
研究者
Dr Gurpreet Singh Saluja
Datta Meghe Institute of Higher Education and Research