A Comparative Study of Incision Closure Methods for Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Primary Outcome Measure
研究概览
简要总结
The aim of the study is to compare incision closure techniques for total knee replacement using a combination of state-of-the-art sutures with tissue adhesives or staples in an effort to identify the best approach with respect to time efficiency, cost, durability, dehiscence, microbial resistance and cosmesis.
The hypothesis is that the combined suture/adhesive approach (sutures for capsule and subcutaneous layers, and tissue adhesive for the final cutaneous layer) or suture/staple approach will be significantly faster and of comparable durability as the conventional exclusive suture approach (sutures used for the capsule, subcutaneous, and cutaneous layers). This is a prospective, randomized, controlled, single site, unblinded (open label) study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria included 18 years or older
- •TKA scheduled without a bilateral planned within one week of the initial surgery
- •Willingness to attend prescribed physical therapy 3 times per week.
排除标准
- •Exclusion criteria included medical conditions or personal circumstances that would prevent participation and completion of physical therapy and follow-up visits
- •Current participation in another clinical trial
- •Preoperative systemic infections
- •Uncontrolled diabetes, or diseases or conditions known to effect the wound healing process
- •Known hypersensitivity to cyanoacrylate
- •Formaldehyde, or the dye D&C Violet #2
- •Prior knee hardware fixation devices
- •Prior knee incisions greater than 9cm, and arthrofibrosis as evidence by limited ROM less than 80°.
结局指标
主要结局
Primary Outcome Measure
时间窗: 1/2009-10/2009
The primary endpoint is the mean procedure time improvement for TKA incision closure using a combined suture/adhesive or suture/staple approach versus suture closure alone.
次要结局
- Mean postop hospital stay(1/2009-10/2009)