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临床试验/NCT04751942
NCT04751942已完成不适用

Post-operative Comparison Between Standard Gradient Compression Dressing vs. Non-Compressive Bioactive Garment on Pain, Swelling and Range of Motion Following Total Knee Arthroplasty

University Hospitals Cleveland Medical Center2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2023年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Change in Leg Circumference (cm)

研究概览

简要总结

This prospective study will evaluate pain, swelling, ROM as well as narcotic use in post-operative total knee arthroplasty patients using novel Non-Compressive Bioactive Garment (NCBG) versus current standard of care gradient compression stocking (Thrombo-Embolic-Deterrent or TED hose). If NCBG proves to be more effective in these outcome areas, it will provide a new and comfortable way to reduce patient pain and swelling immediately following surgery

详细描述

Total knee arthroplasty (TKA) is one of the most popular surgical procedures today. It is designed and proven to effectively reduce pain caused by end-stage osteoarthritis. Despite its achievements, up to 25% of patients remain dissatisfied after the procedure due to lingering pain, amongst other complaints. Post-operative swelling of the knee and leg is thought to be a contributor to this persistent pain.

Traditionally, a standard gradient compression stocking is applied to the knee and leg after surgery to reduce this pain and swelling. However, due to ineffectiveness or patient non-compliance, compression stockings are often not entirely successful at preventing edema. The recently developed NCPS is a lower extremity garment comprised of a technical fabric that is thought to be able to prevent edema and reduce pain all in a comfortable, user-friendly manner. The purpose of this study is to determine if the NCPS is effective at improving post-operative pain, swelling, ROM and analgesic use associated with TKA.

Pain and prolonged recovery time associated with post-operative swelling are two factors that contribute to patient dissatisfaction following TKA. Swelling of the knee following TKA is caused by intraarticular bleeding and inflammation of the periarticular tissues, which can lead to a decrease in functional performance including pain and delayed rehabilitation. In a study by Noble et al, 1/3 of dissatisfied patients reported that their knees swelled at least once per week, leading to pain and discomfort1. Decreased quadriceps strength following knee surgery has been shown to prolong recovery1-8. Fahrer et al showed that knee effusions inhibited reflex neurons and altered kinetics and muscle activity in quadriceps, which ultimately causes decreased strength2. Holm et al later showed us that knee swelling played a part in post-operative quadriceps strength following TKA3. Ultimately, if post-operative swelling can effectively be reduced, patient recovery could be expedited and patient satisfaction could be improved.

Compression stockings have been utilized to attempt to reduce post-operative swelling. Compression works to prevent swelling by reducing the hydrostatic pressure in the leg. Reducing hydrostatic pressure prevents the capillaries from oozing and allows blood to move freely from the superficial to the deep venous system, subsequently allowing excess fluid to flow away from the interstitial space9.

More recently, the use of gradient compression stocking following TKA has come into question for its efficacy. While the application of external pressure from these gradient compression stocking is beneficial for a period, they are often unable to exert a sufficient amount of pressure long enough to prevent painful edema for an extended amount of time. A study by Bowling et al showed that these garments showed sufficient compression during the first few hours after surgery, but the pressure they applied dropped with time and required daily measurements and refitting to maintain appropriate and therapeutic compression10. This poses a problem not only medically, but financially as well. These compression stockings lose their fit so quickly, new ones must be prescribed frequently, leading to costly bills for the patient. It's clear that compression stockings are not as effective as once thought when it comes to controlling pain and swelling post-operatively.

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 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary unilateral Total Knee Replacement - Cruciate retaining and Posterior stabilized designs

排除标准

  • Leg circumference > 23 in.
  • Allergy to silicone/polyester
  • Current DVT
  • Primary Inflammatory Type arthritis (i.e. rheumatoid arthritis)
  • Inability to follow standardized post op and rehab protocols
  • Lymphedema
  • History of Vascular Bypass Surgery on Operative Limb (i.e. Fem-Pop or Fem-Fem)
  • Chronic Narcotic Use History

结局指标

主要结局

Change in Leg Circumference (cm)

时间窗: Preop, 2 weeks post op, 6 weeks post-op, 3 months post-op

circumference of the leg will be measured pre-operatively, immediately post operatively, and at regular intervals post-operatively.

Change in Pain Score (1-10)

时间窗: Pre-op, 1 week Post-op, 2 weeks Post-op, 6 weeks Post-op, 3 months Post-op

patient's subjective pain scores will be recorded daily in a pain journal using a visual analog scale from 1-10, values are grouped into mild (1-3), moderate (4-6), and severe (7-10) pain.

Change in Range of Motion

时间窗: Pre-op, 2 weeks Post-op, 6 weeks Post-op, 3 months Post-op

patients passive flexion range of motion will be tested pre-operatively, immediately post-operatively, and at regular intervals post-operatively

Change in Narcotic Consumption

时间窗: 1 week Post-op, 2 weeks Post-op. 6 weeks Post-op, 3 months Post-op

the narcotic consumption in Milligrams of morphine equivalents (MME) per day will be recorded post-operatively while in the hospital and will be self reported by the patient in a journal as "number of pills" taken

Change in Knee Society Score (KSS)

时间窗: Pre-op, 1 week Post-op, 2 weeks Post-op, 6 weeks Post-op, 3 months Post-op

a validated system that combines an objective physician-derived component with a subjective patient-derived component that evaluates pain relief, functional abilities, satisfaction, and fulfillment of expectations. Patients will fill out this questionnaire pre-operatively and at each post-operative visit. With lower scores indicating lower pain/difficulty with daily activities and higher scores indicating higher pain/difficulty with daily activities.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rachael Kilkenny

Orthopedic Program Coordinator

University Hospitals Cleveland Medical Center

研究点 (2)

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