Use of Cryopressotherapy in Patiens Undergoing Total Knee Replacement to Improve Clinical Outcome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 14 Days Postoperatively
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of cryopressotherapy in patients undergoing total knee arthroplasty by assessing clinical improvement using the KOOS at 14 days after surgery.
Analysis of the knee Range of Motion (ROM) in the preoperative phase, at the predischarge visit, and at the follow-up visit for suture removal performed 14 days after surgery.
Analysis of PROMs such as: Oxford Knee Score (OKS), Joint Forgotten (JF), NRS score, and SF-12.
These questionnaires will be collected in the preoperative phase, at the predischarge visit, and at the follow-up visit for suture removal performed 14 days after surgery.
To evaluate whether cryopressotherapy leads to an improvement in predischarge hemoglobin (Hb) levels.
To assess whether cryopressotherapy reduces the circumference and subcutaneous fluid accumulation of the operated limb.
详细描述
Knee osteoarthritis is a degenerative condition that causes cartilage wear, leading to pain, stiffness, and difficulty moving. It mainly affects older adults, but it can also occur in younger individuals in cases of genetic predisposition or trauma. Symptoms include pain during or after physical activity, swelling, and difficulty walking.
Initial treatment is based on physiotherapy, anti-inflammatory medications, and injections, but if the disease progresses, a total knee replacement with a prosthesis may become necessary. Modern prostheses are made with advanced materials and minimally invasive surgical techniques, improving postoperative recovery.
Using ice in the first few days after surgery is crucial to reducing pain and swelling, improving functional recovery, and lowering the need for pain medications, such as opioids. Moreover, ice therapy promotes early rehabilitation and reduces hospitalization time. Cryotherapy may also help lower healthcare costs thanks to more effective pain management.
Advanced continuous cooling devices, although promising, require further studies to confirm their effectiveness.
The aim of the study is therefore to assess whether the cryopressotherapy protocol leads to an improvement in clinical outcomes in patients undergoing total knee arthroplasty (TKA), earlier mobilization, and reduced use of pain medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates for elective total knee arthroplasty surgery (indication determined solely by the Orthopedic Surgeon)
- •Patients aged between 18 and 80 years (inclusive) for both groups
- •Body Mass Index (BMI) between 18 and 35 kg/m²
- •Willingness and ability to provide informed consent
- •Patients with non-inflammatory degenerative knee joint disease, including osteoarthritis
排除标准
- •Use of medications that may interfere with muscle metabolism
- •Bone metastases or diseases at the surgical site
- •Presence or suspicion of infection at the knee
- •Inability to provide informed consent
- •Obesity (BMI ≥ 35 kg/m²)
- •Patients requiring revision surgery of total knee arthroplasty
- •Patients with pacemakers and/or mechanical implants or those who may be affected by BIA interference
研究组 & 干预措施
Group A: will undergo a cryopressotherapy protocol using a dedicated device/machine.
Cryopressotherapy treatment (using the device) consists of applying the machine in 6-hour cycles per day, to be performed 3 hours in the morning and 3 hours in the afternoon during the 4 days after surgery.
干预措施: Cryopressotherapy (Device)
Group B: will undergo a cryotherapy protocol using ice.
Cryotherapy (i.e., cold therapy) consists of applying local ice using an ice pack 3 times per day, with 1-hour applications alternating 15 minutes on and 15 minutes off during the first 4 days after surgery.
干预措施: Ice pack (Device)
结局指标
主要结局
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 14 Days Postoperatively
时间窗: Preoperative assessment and 14 days postoperatively.
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a patient-reported questionnaire consisting of 5 subscales: Pain, Symptoms, Activities of Daily Living (ADL), Sport and Recreation Function, and Knee-Related Quality of Life. Each subscale is scored separately and transformed to a 0-100 scale, where 0 represents extreme knee problems and 100 represents no knee problems. The outcome measure is the change from preoperative baseline to 14 days postoperatively in KOOS scores
次要结局
- Analysis of the knee Range of Motion (ROM) in the preoperative phase(Preoperative assessment; pre-discharge visit; 14 days postoperatively (suture removal visit).)
- Analysis of PROMs (Patient-Reported Outcome Measures): Oxford Knee Score (OKS)(Preoperative assessment; pre-discharge visit; 14 days postoperatively (suture removal visit).)
- Analysis of PROMs (Patient-Reported Outcome Measures): Forgotten Joint Score (FJS-12)(Pre-discharge visit; 14 days postoperatively (suture removal visit).)
- Analysis of PROMs (Patient-Reported Outcome Measures): Numerical Rating Scale (NRS) for pain(Preoperative assessment; pre-discharge visit; 14 days postoperatively (suture removal visit))
- Analysis of PROMs (Patient-Reported Outcome Measures): Short Form-12 Health Survey (SF-12)(Preoperative assessment; pre-discharge visit; 14 days postoperatively (suture removal visit))
- Improvement in hemoglobin (Hb) levels(Preoperative assessment and pre-discharge visit)
- Change in operated limb circumference(Preoperative assessment; pre-discharge visit; 14 days postoperatively.)