Home Rehabilitation in Patients After Primary Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Total WOMAC Score
研究概览
简要总结
The investigators include patients attending the outpatient clinic in the area of Orthopedics and Traumatology of the investigators hospital with a diagnosis of knee osteoarthritis, which treatment requires surgery. Patients will be divided into two groups. In both groups, they will be given verbal, clear and detailed information on the approach to follow, the exercises given in brochures, and in the study group a schedule will be given in order to record rehabilitation exercises in patients after total knee replacement (TKA). Both groups will be assessed before and after surgery, together with outpatient follow-up by, WOMAC, Visual Analogue Scale and OKS (Oxford Knee Score).
详细描述
Osteoarthritis (OA) is the most common rheumatic disease worldwide. OA cause joint pain and occupational disability in the adult population. In Mexico, OA is one of the top ten reasons of consultation in primary attention care.
Joint arthroplasty is a major advance in the treatment of chronic joint pain. It is indicated in patients in whose conservative medical therapy has failed. Total knee arthroplasty (TKA) is a surgery that reduces pain and improves function and quality of life in patients with knee disorders, actually is one of the most successful medical procedures. However, a critical consideration in patients with TKA is the successful control of postoperative pain. An adequate pain control allows faster rehabilitation, reduces complications and is highly correlated with patient satisfaction. A multimodal pain management decreases the use of narcotics, improve pain scores, increase patient satisfaction and allows early recovery.
Regarding postoperative rehabilitation, its suggested that rehabilitation programs are based on a biopsychosocial philosophy and integrate exercises and self-management interventions are effective in the treatment of osteoarthritis. Rehabilitation therapy an important area that should be considered. It helps people recover faster from their illness, injury or medical procedures and make possible to get back to their daily activities.
The World Health Organization describes rehabilitation as a process that aims to enable people to maintain and achieve their physical, sensory, intellectual, functional, psychological and social level in an optimal way. It is known that rehabilitation involves contributions from various health disciplines, including physical therapy and occupational therapy and offered in inpatient, outpatient and community patients.
In patients with total knee replacement, rehabilitation interventions may involve education and exercise before surgery, early mobilization while being in the hospital and a postoperative program, along with an adequate pain management.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 90 years
- •Patients with Knee osteoarthritis (OA) grade 4 ( Kellgren-Lawrence based on radiographic findings)
- •Total Knee Arthroplasty (TKA) for primary OA
- •Rapid rehabilitation desire
排除标准
- •Age <18 and > 90 years
- •Patients with Knee osteoarthritis grade 1-2 ( Kellgren-Lawrence based on radiographic findings)
- •Patients with asociated Rheumatic syndromes
- •Patients with anticoagulant therapy
- •Patients with hepatic problems, Diabetes Mellitus, Coagulopathy, hearth conditions, immunodepressed, or infections
- •Drugs abuse history
- •Physiatric disease
- •Pregnant patients
- •Patients with hemoglobin values < 11g/dl , platelets < 150,000/ μL
结局指标
主要结局
Total WOMAC Score
时间窗: up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months)
The total score is provided for Western Ontario and McMaster Universities Arthritis Index (WOMAC). It is a widely score used in the evaluation of Hip and Knee Osteoarthritis. Consists of a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain (5 items), stiffness (2 items), and physical functioning (17 items) of the joints. * Scale Range: 5 items of pain (score range 0-20), 2 items for stiffness (score range 0-8), and 17 items for functional limitation (score range 0-68). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Total WOMAC score range 0-96. * For each subscale higher values represent worse outcomes. * Subscales are summed for a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. WOMAC Index was developed in 1982 at Western Ontario and McMaster Universities.
次要结局
- Visual Analog Scale (Measure of Pain Intensity)(up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months))
研究者
FELIX VILCHEZ CAVAZOS
MD-PhD
Universidad Autonoma de Nuevo Leon