Assessing the outcomes of anterior cruciate ligament reconstruction with or without the use of antibiotic solution in graft preparation: A Randomised control trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- To compare the infection rates in patients undergoing ACL reconstruction surgery
研究概览
简要总结
Aim of the study is to evaluate and compare the outcomes of ACL reconstruction procedures specifically examining the use of antibiotic solutions during graft preparation. Study population includes patients with ACL tear admitted in orthopaedic department of RIMS Ranchi.Computer generated random numbers will be used for randomisation and simple randomisation will be used to allocate two groups in equal halves. For one group, antibiotic soaked grafts will be used during ACL reconstruction surgery and in other group, no such solution will be used. Follow-up will be done on post operative day- 2,6 and 10 to compare the infection rates between the two groups. Secondary follow-up will be done 1 month and 3 months after surgery to compare graft failure between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Individuals diagnosed with a complete rupture of the ACL who are indicated for surgical reconstruction b) patients willing to provide informed consent to participate in the study c) patients with no history of no prior ACL reconstruction surgery d) patients without significant comorbidities or medical conditions.
排除标准
- •a) patients with concurrent injuries involving multiple major ligaments of the knee b) patients younger than 18 years or older than 65 years c) patients with previous history of ACL reconstruction of the same knee d) patients with active systemic or local infection.
结局指标
主要结局
To compare the infection rates in patients undergoing ACL reconstruction surgery
时间窗: Postoperative day(POD)- 2,6,10
次要结局
- a) To evaluate the incidence of graft failure(graft rupture or re-tear) between the two study groups(b) to explore whether patients characteristics such as age, sex, BMI and previous medical history influence the clinical outcomes and infection rates in both study groups)
研究者
Kumar Gourab
Rajendra Institute of Medical Sciences, Ranchi