Prospective, Assessment of Vitamin D and Calcium Supplementation, Improvement of Nutritional Status and Preoperative Rehabilitation in Patients Before Knee Arthroplasty.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pain control satisfaction assessed on the Visual Analogue Scale (VAS)
研究概览
简要总结
Prospective randomized study of 150 patients qualified for knee arthroplasty between 2015 and 2017. Patients were randomized into 3 groups receiving vitamin D and calcium supplementation, increased protein supply and preoperative rehabilitation, respectively.
Following factors were analyzed: changes in vitamin D3, calcium, total protein, albumin and CRP levels during preparation for surgery, nutritional status on the Subjective Global Assessment (SGA) scale, osteoporosis risk assessment according to the Osteoporosis Risk SCORE, level of pain felt on the scale VAS and the number of analgesics used, the result of the Duke Activity Status Index, the result of the following scales: Cardiac Risk Index for Orthopedic Surgery (Lee), Knee injury and Osteoarthritis Outcome Score (KOOS), Fear Avoidance Beliefs Questionnaire (FABQ) about Physical Activity, The Quality of Life Scale (QOLS). Additionally, the occurrence of perioperative complications was analyzed (e.g. venous thrombosis and pulmonary embolism, wound or joint infection, excessive bleeding, loosening of the implant, bone fracture or fracture, pain).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with a disease lasting more than 5 years and without total limitation of physical fitness,
- •reporting pain> 5 on the VAS scale (Visual Analogue Scale)
- •general fitness according to the ASA (Amercican Society of Anestesiology) scale up to 3
排除标准
- •patients with metabolic and systemic disorders with contraindications for calcium substitution, vitamin D3 and protein supply,
- •intolerance of physical effort> 2, 5 MET (Metabolic Equivalent of Task)
- •limitation of the degree overall efficiency> 3 in the ASA classification
研究组 & 干预措施
Intervention group 1
Protein supplementation BID, Vitamin D and calcium supplementation Vitamin D 2000 IU / d, calcium 1000mg/d, exercise 6 months
干预措施: Intervention group 1 (Behavioral)
Intervention group 2
Protein supplementation QD, Vitamin D and calcium supplementation Vitamin D 1000 IU / d, calcium 500mg/d, exercise 3 months
干预措施: Intervention group 2 (Behavioral)
Control group 0
no protein supplementation , no Vitamin D and calcium supplementation , no exercise
干预措施: Control group 0 (Behavioral)
结局指标
主要结局
Pain control satisfaction assessed on the Visual Analogue Scale (VAS)
时间窗: 18 months
Visual Analogue Scale (VAS) is a measure determining the intensity of pain by means of a visual analogue scale. Subject is marking the examined point on a line of 10 cm long, where the value 0 is assigned the total absence of pain, and 10 the strongest pain that can be imagined.
Vitamin D concentration in blood, based on laboratory analysis.
时间窗: 18 months
Concentration of vitamin D in blood is a laboratory parameter, measured in unit of ng/ml. Levels below 20 ng/ml is a severe vitamin D deficiency condition that requires treatment. The result in the range 20-30 ng/ml means that the vitamin level is not sufficient. Values between 30-50 ng/ml are considered normal. This is one of the basic laboratory parameters for assessing the body's bone mineral metabilism.
Efficiency of the knee joint assessed on The Knee Injury and Osteoarthritis Outcome Score (KOOS) scale.
时间窗: 18 months
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury. The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
次要结局
- Calcium ionized concentration in blood, based on laboratory analysis.(18 months)
- Total protein concentration in blood, based on laboratory analysis.(18 months)
- Albumin concentration in blood, based on laboratory analysis(18 months)
- C-reactive protein (CRP) concentration in blood, based on laboratory analysis(18 months)
- Efficacy of protein supplementation assessed on the Subjective Global Assessment (SGA) scale.(18 months)
- Efficacy of vitamin D and calcium supplementation assessed on the Simple Calculated Osteoporosis Risk Estimation (SCORE) scale.(18 months)
- Acceptability of physical activity based on Duke Activity Status Index (DASI) scale.(18 months)
- Incidence of cardiovascular hazard based on Cardiac Risk Index for Orthopedic Surgery (Lee) scale.(18 months)
- Unwillingness of phisical activity due to pain based on Fear Avoidance Beliefs Questionnaire (FABQ) scale.(18 months)
- The Quality of Life based on The Quality of Life (QOLS) scale.(18 months)
- Incidence of Treatment-Emergent Adverse Events (AE) as assessed by frequency.(18 months)
研究者
Bartlomiej Szpyra
Principal Investigator
Jagiellonian University