Evaluation of Standard TED Stocking vs. Reparel Bioactive Garment on Postoperative Leg Swelling, Pain and DVT Rates After Hip Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- HOOS Jr. Score
研究概览
简要总结
This randomized, prospective study compares the effectiveness of a novel bioactive garment (Reparel Leg Sleeve) versus standard TED compression stockings in reducing postoperative leg swelling, pain, and deep vein thrombosis (DVT) rates following total hip arthroplasty. The study aims to determine whether the bioactive garment improves patient comfort and recovery outcomes compared to traditional stockings.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-89
- •Undergoing primary unilateral total hip replacement
- •BMI < 40
- •Able to follow postoperative protocol
- •English speaking
排除标准
- •Age <18 or >90
- •Physical inability to use stockings
- •Allergy to silicone/polyester
- •Active DVT
- •History of vascular bypass on operative limb (e.g., Fem-Pop, Fem-Fem)
- •Inability to comply with post-op/rehab
- •Lymphedema
结局指标
主要结局
HOOS Jr. Score
时间窗: Postoperative Weeks 6 and 12
The Hip Disability and Osteoarthritis Outcome Score, Junior (HOOS Jr.) evaluates hip function and patient-reported symptoms following total hip arthroplasty.
VR-12 Score
时间窗: Postoperative Week 12
The Veterans RAND 12-Item Health Survey (VR-12) evaluates patient-reported physical and mental health status.
HSS Satisfaction Score
时间窗: Postoperative Week 12
The Hospital for Special Surgery (HSS) Satisfaction Score assesses patient satisfaction following hip replacement surgery.
Forgotten Joint Score
时间窗: Postoperative Week 12
The Forgotten Joint Score measures the extent to which patients are aware of their hip joint during daily activities, reflecting functional recovery.
Pain Score (VAS)
时间窗: Postoperative Weeks 2, 6, and 12
Pain will be measured using the Visual Analog Scale (VAS), a standard 0-10 numeric rating scale. Patients will report pain levels during routine postoperative follow-up visits or via validated questionnaires.
次要结局
- Leg Swelling (Clinical Evaluation)(Postoperative Weeks 2, 6, and 12)
- Incidence of Deep Vein Thrombosis(Up to 12 weeks after surgery)
- Postoperative Narcotic Use(Collected at 2, 6, and 12 weeks after surgery)
- Study Questionnaire Responses(Weeks 2, 6, and 12 postoperatively)