The Utility of Closed Suction Drainage in Total Shoulder Arthroplasty: A Prospective Analysis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin level
研究概览
简要总结
The purpose of this study is to determine the limited effectiveness of drains during Total Shoulder Arthroplasty. Drains are used during joint arthroplasty procedures to decrease infection rates, swelling,and the number of dressing changes required during a hospital stay. The use of drains has been heavily investigated in the hip and knee replacement literature, but there have been no investigations regarding their use in shoulder replacements, despite frequent use.
Clinical benefit has not been consistently documented regarding drain usage in hip and knee arthroplasty and the investigators hypothesize that they are of limited utility in total shoulder arthroplasty as well. The investigators will perform a prospective investigation of total shoulder arthroplasty patients- dividing them into two groups- half will receive a drain at the time of surgery and the other half will not be receiving a drain.
详细描述
The use of closed-suction draining has been well studied in the hip and knee arthroplasty literature. Drains have been used with the intention of decreasing infection, ecchymoses, and frequency of dressing changes. Some have reported a corresponding decrease in hematocrit for patients receiving post-op drainage leading to increased transfusion needs. Given that no clinical benefit has been consistently documented regarding drain usage in knee and hip arthroplasty, they are no longer routinely used in those operations. The use of such drainage systems in shoulder arthroplasty, however, has not been studied and the benefit of drain use in regards to patient outcomes is questionable. As such, the study is a prospective investigation comparing outcomes in two groups of total shoulder arthroplasty patients, those receiving a drain at the time of surgery and those without a drain. The short-term outcome measurements include peri-operative hematocrit and hemoglobin, infection rate, hematoma development, transfusion requirement, ecchymosis and wound complication. Long-term outcomes include shoulder functional scores as measured by post-operative visits and any need for revision shoulder surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Glenohumeral Osteoarthritis undergoing total shoulder arthroplasty
排除标准
- •Patients undergoing total shoulder arthroplasty following trauma, failed prior surgery/revision or infection
研究组 & 干预措施
TSA with drain placement
Hemovac drains are placed in subjects during standard Total Shoulder Arthroplasty involving the replacement of damaged shoulder components with shoulder prosthesis.
干预措施: Wound drainage (Procedure)
TSA with drain placement
Hemovac drains are placed in subjects during standard Total Shoulder Arthroplasty involving the replacement of damaged shoulder components with shoulder prosthesis.
干预措施: Total Shoulder Arthroplasty (Procedure)
TSA without drain placement
Hemovac drains will not be placed in subjects during standard Total Shoulder Arthroplasty involving the replacement of damaged shoulder components with shoulder prosthesis.
干预措施: Total Shoulder Arthroplasty (Procedure)
结局指标
主要结局
Change in Hemoglobin level
时间窗: Day 0 post-operative, day 1 post-operative, day 2 post-operative
To assess blood loss
Change in Hematocrit level
时间窗: Day 0 post-operative, day 1 post-operative, day 2 post-operative
To assess blood loss
次要结局
- Total length of hospital stay(Day 0 post-operative to discharge, an average of up to 3 days)
- Total cost incurred during hospital stay(Pre-surgical admitting to discharge, an average of up to 3 days)
- Change in Elbow Surgeons Evaluation Form (ASES) score(Baseline, 6 month post-operative, 1 year post-operative, 2 year post-operative)
- Number of subjects that developed any of the following: wound compromise, ecchymosis, bleeding, hematoma formation or infection(Day 0 post-operative to discharge, an average of up to 3 days)
- Total Drain Output record(Day 1 post-operative, day 2 post-operative)
- Number of subjects that presented with anatomic healing after total shoulder arthroplasty(6 month post-operative, 1 year post-operative, 2 year post-operative)
- Change in Disabilities of the Arm Shoulder and Hand (DASH) Score(Baseline, 6 month post-operative, 1 year post-operative, 2 year post-operative)
研究者
Christopher S. Ahmad, MD
Professor of Orthopedic Surgery at the Columbia University Medical Center
Columbia University