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临床试验/NCT07302724
NCT07302724进行中(未招募)不适用

Drain Removal Before Versus After Continuous Passive Motion in Primary Total Knee Arthroplasty: Impact on Residual Hematoma in a Prospective Controlled Study

Ankara Etlik City Hospital1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2025年6月15日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
104
试验地点
1
主要终点
Residual Hematoma Formation

研究概览

简要总结

The aim of this prospective randomized controlled study was to determine whether the timing of drain removal in relation to continuous passive motion (CPM) application influences postoperative residual hematoma formation following primary total knee arthroplasty (TKA). Our primary hypothesis was that removing the drain after initiating CPM would result in less residual hematoma, as CPM-induced intra-articular fluid and blood mobilization would be evacuated through the drain before its removal, thereby reducing postoperative fluid accumulation.

详细描述

This prospective, parallel-group interventional study was conducted at a single tertiary care center between June 2025 and December 2025 following approval by the institutional ethics committee. All patients provided written informed consent prior to participation.

A total of 104 consecutive patients undergoing primary unilateral total knee arthroplasty (TKA) were enrolled during the study period. During follow-up, four patients from each group were lost, leaving 96 patients available for final analysis.

Participants were allocated into two groups using a sequential alternating allocation method (2-1-2-1 sequence). Although not computer-generated, this prospective allocation approach ensured balanced group sizes throughout enrollment. Due to the nature of the intervention, allocation concealment and blinding were not applied.

All surgical procedures were performed by senior arthroplasty surgeons using a standardized medial parapatellar approach under spinal anesthesia. A uniform perioperative protocol was applied to all patients, including antibiotic prophylaxis with intravenous cefazolin and thromboembolism prophylaxis with low-molecular-weight heparin. All procedures were performed under tourniquet control. A single standard intra-articular hemovac drain of identical size and model was placed in all patients prior to wound closure.

Postoperatively, all patients underwent a standardized continuous passive motion (CPM) protocol approximately 24 hours after surgery. CPM was applied for 1 hour with a motion range of 0-90 degrees under supervision of the physiotherapy team.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Age 18 years or older
  • Undergoing primary unilateral total knee arthroplasty (TKA) for end-stage knee osteoarthritis
  • Able to provide written informed consent
  • Able to comply with scheduled postoperative follow-up assessments

排除标准

  • Revision total knee arthroplasty
  • Previous infection in the index knee
  • Inflammatory arthropathy
  • Neuromuscular disorders affecting lower extremity function
  • Inability to attend follow-up visits

结局指标

主要结局

Residual Hematoma Formation

时间窗: Preoperative; Postoperative Day 2; Day 14; Day 28

Residual hematoma formation assessed by knee circumference measurements at the level of the superior pole of the patella. Circumference is measured on both the operated and contralateral knees. The difference from baseline and between-group differences are evaluated.

次要结局

  • Wound Healing(Postoperative Day 2; Day 14)
  • Range of Motion (ROM)(Preoperative; Postoperative Day 2; Day 14; Day 28)
  • Oxford Knee Score(Preoperative; Postoperative Day 28)
  • Pain Assessment(Preoperative; Postoperative Day 14; Day 28)
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Preoperative; Postoperative Day 28)
  • Lysholm Knee Score(Preoperative; Postoperative Day 28)

研究者

发起方
Ankara Etlik City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Kemal Şibar

Orthopedic Surgeon, Principal Investigator

Ankara Etlik City Hospital

研究点 (1)

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