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临床试验/NCT04508101
NCT04508101Unknown不适用

The Role of Suction Drainage in the Management of Peri-operative Bleeding in Total and Unicomcompartmental Knee Arthroplasty: a Comparative Retrospective Study

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio0 个研究点目标入组 153 人开始时间: 2020年8月7日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
153
主要终点
Hemoglobin trend

研究概览

简要总结

Although, suction drainage is routinely used in orthopedic clinical practice, there are still no precise guidelines on its use in total joint arthroplasty, particularly in total as well as unicompartmental knee arthroplasty. In fact, drain use is likely associated to an increased risk of blood transfusion due to the lack of tamponade effect, as well as a higher infection rate. Furthermore, the drain itself could interfere with knee mobilization, delaying its functional recovery. Thus, the aim of this study was to investigate the real usefulness of suction drainage in perioperative bleeding control in the management of total as well as unicompartmental knee arthroplasty.

详细描述

Knee arthroplasty is currently a widespread treatment either for osteoarthritis (OA) as well as other joint disorders. Specifically, total knee arthroplasty (TKA) is commonly considered one of the most effective orthopedic procedure in the treatment of end-stage knee OA as well as various rheumatic diseases such as rheumatoid arthritis, leading to a substantial pain relief and functional improvement. Besides, unicompartmental knee arthroplasty (UKA) represents a viable alternative in the treatment of unicompartmental knee OA showing a lower morbidity. Nevertheless, since knee arthroplasty involves soft tissue dissections and numerous bone cuts, several perioperative complications can be observed. Particularly, the subsequent local hemorrhage can lead to anemia, functional limitation, nerve palsy as well as increase in wound tension resulting in healing impairment. Moreover, the local hematoma could represent a growth environment for bacteria. Although TKA usually shows a higher hemorrhage rate, some patients undergoing UKA still show the aforementioned complications. Accordingly, intraarticular suction drainage placement can likely ease the hematoma drain, leading to swelling decrease, surgical wound healing improvement as well as reduction of postoperative infections. However, despite suction drainage is routinely used in TKA as well as UKA, there are still no precise guidelines and its effectiveness remains controversial. Indeed, drain use is likely associated to an increased risk of blood transfusion due to the lack of tamponade effect, as well as a higher infection rate. Moreover, the drainage conduit could obstruct physiotherapy leading to a delayed recovery. Therefore, since fast-track program has been increasingly applied in the management of TKA and UKA, an early drainage removal is recommended. Thus, the aim of this study was to investigate the real usefulness of suction drainage in perioperative bleeding control in the management of TKA and UKA.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • knee osteoarthritis diagnosis
  • No contraindications to antithrombotic prophylaxis
  • Availability of blood tests results before surgery as well as in the first three postoperative days.
  • Detailed description of clinical records

排除标准

  • contraindications to antithrombotic prophylaxis
  • anti-platelet therapy
  • knee arthroplasty revision indication

结局指标

主要结局

Hemoglobin trend

时间窗: 4 days

Hemoglobin values comparison between the two groups

次要结局

  • Knee swelling(5 days)
  • Need for transfusion(5 days)
  • Wound bleeding(5 days)

研究者

发起方
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
申办方类型
Other
责任方
Sponsor

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