Oral Nutritional Optimization in Total Joint Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Changes in the patients' albumin, pre-albumin, and/or transferrin levels
研究概览
简要总结
The purpose of this study is to determine the effect on hematological markers of nutritional intervention on nutritionally deficient patients following total joint replacement surgery.
详细描述
Numerous pre-operative modifiable variables have been extensively investigated for their effect on outcomes in TJA. These include metabolic diseases such as diabetes mellitus, obesity, and smoking status. However, nutritional status has not been as thoroughly investigated; to date, no prospective randomized control study has assessed the effect of oral nutritional supplementation for malnourished patients. This study will be a novel investigation into the role for routine serum screening for malnutrition as well as oral nutritional supplementation in TJA patients. This study could serve as a stepping stone towards creating a new pathway to highlight at-risk patients and pre-operatively optimizing their outcomes after TJA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient are current candidates for elective primary total hip and total knee arthroplasty
- •Patients ≥55 years of age but ≤ 95
- •Patients who meet at least one of the following three laboratory criteria for malnutrition:
- •TSerum Albumin: ≤3.5 mg/dl Pre-Albumin: <15 mg/dl Transferrin: <200 mg/dl
排除标准
- •Previous history of septic arthritis
- •Allergy to oral supplementation
- •Inability to consume oral supplementation
- •Protein malabsorption syndromes
- •Eating disorders
- •End stage renal and hepatic disease
- •Revision surgery, non-elective surgery, hemiarthroplasty, and unicompartmental knee arthroplasty
研究组 & 干预措施
No Nutritional supplementation
Treatment as usual
结局指标
主要结局
Changes in the patients' albumin, pre-albumin, and/or transferrin levels
时间窗: Visit 2 (2 wks pre) Visit 3 (surgery day) Visit 5 (4 weeks post)
Biological specimen collection and laboratory evaluations- all included patients' hematologic markers of malnutrition (albumin, pre-albumin, and transferrin) will be recorded at 2 weeks prior to surgery, the day of surgery, and 6 weeks. These blood tests can all be performed from one sample of blood at each visit. The results will then be accessed via the EMR
次要结局
未报告次要终点