Swelling Management After Total Knee Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 4
- 主要终点
- Swelling (bioelectrical impedance)
研究概览
简要总结
To determine if inelastic adjustable compression garment results in improved surgical limb swelling control (bioimpedance assessment - primary outcome) after TKA compared to control (TED hose).
详细描述
Total knee arthroplasty (TKA) is commonly performed to address disability from end-stage osteoarthritis (OA) in older adults and is expected to increase five-fold by 2040 to 3.5 million TKAs annually. Although TKA is effective at reducing pain, it is a substantial acute trauma to the joint that exacerbates the underlying weakness and disability common with OA, leading to long-term atrophy and further disability. Attenuation of this acute loss of strength and function leads to improved long-term outcomes. Key to preventing this acute loss is effectively managing postoperative knee swelling.
Knee swelling after TKA is profound and is theorized to be a major driver of this acute strength and functional loss. The average level of swelling peaks at a 35% increase in the first week after surgery. During the initial postoperative period, quadriceps strength decreases by 60% leading to decreases in functional performance of up to 90%. This early postoperative strength loss is driven by a deficit in quadriceps activation which limits rehabilitation potential acutely and leads to long term losses of quadriceps strength up to 42%. Quadriceps weakness results in long-term decreases in gait speed, balance, stair-climbing ability, and chair rise ability. Early functional decline increases the risk for falls and disability later in life. Furthermore, postoperative knee swelling has also been associated with increased pain, decreased range of motion (ROM) and post-surgical complications, such as deep venous thrombosis (DVT) and infection. However, traditional postoperative interventions such as elastic compression stockings (thromboembolism-deterrent [TED] hose) have demonstrated minimal effectiveness in reducing swelling after TKA.
The investigators have demonstrated in a pilot cohort study (N=16) that an inelastic, adjustable compression garment was related to decreases in swelling by 50% in the early postoperative period. However, there is a need to more formally evaluate the effects of this garment in a more robust design as well as determine the preliminary effects of this garment on important downstream clinical outcomes (e.g., strength and function) prior to initiating a larger clinical trial.
Therefore, the investigators propose a randomized controlled study of 58 older adult participants undergoing TKA to determine if the utilization of an inelastic adjustable compression garment (INCOM) reduces postoperative swelling more than elastic TED hose (CONTROL). Both groups will wear the assigned garments for the first three weeks after TKA and participate in a standardized rehabilitation program after TKA. Outcomes will be assessed preoperatively and postoperatively at weeks 1,2, 3 (end of intervention), and 12.
AIM 1: To determine if INCOM results in improved surgical limb swelling control (bioimpedance assessment - primary outcome) after TKA compared to CONTROL.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary, unilateral total knee arthroplasty (TKA)
- •Age 50 years or older
排除标准
- •Surgical complication necessitating an altered course of rehabilitation
- •Unable to attend outpatient rehabilitation 2x/week for 3 weeks following surgery
- •Inability to don/doff garment
- •Neurological, cardiovascular, or unstable orthopedic conditions that limit function
- •Medical conditions that cause chronic lower extremity swelling
- •Contralateral TKA within past year
- •Pain >5/10 in their contralateral knee or definite plans on having their other knee replaced in the next year
- •Current tobacco smoker
- •Use of illegal drugs
- •Uncontrolled diabetes (hemoglobin A1c level >8.0)
- •Body mass index >40 kg/m2
结局指标
主要结局
Swelling (bioelectrical impedance)
时间窗: Baseline testing will occur 2-14 days prior to TKA at the Portercare Adventist campus. Postoperative testing will occur at weeks 1, 2, 3 (primary endpoint), and 12.
Testing will be performed with a RJL Systems Quantum (Clinton Township, MI) bioelectrical impedance device, which delivers a 2.5 uA alternating current at a frequency of 50kHz. Testing will be performed with a four-wire measurement method, consisting of two current-injecting electrodes represented by the red leads (below) and two measuring electrodes (black leads) that detect the voltage drop across the limb. Fours surface electrodes will then be systematically placed on the lower extremity along the second ray on the dorsal surface of the foot separated by 10 cm and at 10 and 20 cm proximal to the superior pole of the patella on the anterior surface of the thigh. Lower levels of impedance represent the increased fluid content present with greater levels of swelling. Measuring the impedance of both the involved and uninvolved limb allows for calculation of ratio (involved/uninvolved).
次要结局
- Quadriceps strength and activation testing(Baseline testing will occur 2-14 days prior to TKA at the Portercare Adventist campus. Postoperative testing will occur at weeks 3 (primary endpoint) and 12.)
- Numeric pain rating scale(Baseline testing will occur 2-14 days prior to TKA at the Portercare Adventist campus. Postoperative testing will occur at weeks 1, 2, 3 (primary endpoint), and 12.)
- Range of motion(Baseline testing will occur 2-14 days prior to TKA at the Portercare Adventist campus. Postoperative testing will occur at weeks 1, 2, 3 (primary endpoint), and 12.)
- 30-second Sit to Stand test (30-STS)(Baseline testing will occur 2-14 days prior to TKA at the Portercare Adventist campus. Postoperative testing will occur at weeks 1, 2, 3 (primary endpoint), and 12.)
- Timed Up and Go test (TUG)(Baseline testing will occur 2-14 days prior to TKA at the Portercare Adventist campus. Postoperative testing will occur at weeks 1, 2, 3 (primary endpoint), and 12.)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Baseline testing will occur 2-14 days prior to TKA at the Portercare Adventist campus. Postoperative testing will occur at weeks 1, 2, 3 (primary endpoint), and 12.)