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临床试验/NCT02926235
NCT02926235终止4 期

Randomized Control Trial of Essential Amino Acid Supplementation in Protein Deficient Patients Following Total Knee Arthroplasty

Hospital for Special Surgery, New York1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
入组人数
50
试验地点
1
主要终点
Change Quad Strength

研究概览

简要总结

The goal of this trial is to assess the efficacy of essential amino acids (EAA) on muscle atrophy and malnutrition compared to a placebo in patients following a total knee arthroplasty. The investigators specific objectives included analysis of (1) muscle strength, (2) change in malnutrition, (3) perioperative complications (4) physical activity.

详细描述

Three orthopedic surgeons will participate in the study (MBC, DJM, SAJ). The surgical procedure will be performed as per each surgeon's routine practice. Patients will be asked to ingest 20g of EAA or placebo two times a day between meals 1 week prior and 2 weeks postoperatively. Patients will be given a pill organizer that has two doses per day with either EAA or placebo. Thigh circumference will be measured at baseline, 2 weeks and 6 weeks post-operatively. The mid-thigh measurement will be taken while the patient stands erect with their feet slightly apart and their weight equally distributed. The girth measurement is taken perpendicular to the long axis of the thigh. The tape measure will be placed at the level midway between the trochanterion and tibiale laterale sites each time to ensure that the same location is measured each time. The investigators will measure strength using a handheld dynamometer and performing a straight leg raise and knee extension at 90 degrees on the operative and the non-operative leg preoperatively, 2 weeks and 6 weeks post-operatively. The medial and lateral epicondyles of the femur will be used to position the subject's knee joint through the axis of rotation on the dynamometer. Strength will be tested at 30, 45 and 60 degrees of flexion. Physical activity will be collected using the Knee Society Score at baseline and at 6 weeks postoperatively. After the trial is commenced, there will be no additional enrollment once study numbers have been met.

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
Single (Participant)

入排标准

年龄范围
40 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients will be undergoing a primary unilateral total knee arthroplasty for a diagnosis of osteoarthritis

排除标准

  • All patients who were wheelchair bound preoperatively
  • All patients who cannot participate in an outpatient physical therapy program for 3 days per week after surgery

研究组 & 干预措施

Amino Acid

Experimental

Patients will be asked to ingest 20g of EAA o two times a day between meals 1 week prior and 2 weeks postoperatively.

干预措施: Amino Acid (Drug)

Placebo

Placebo Comparator

Patients will be asked to ingest 20g of placebo two times a day between meals 1 week prior and 2 weeks postoperatively.

干预措施: Placebo (Other)

结局指标

主要结局

Change Quad Strength

时间窗: Change between preop and 6 weeks.

As Measured by Quad circumference in inches

次要结局

未报告次要终点

研究者

发起方
Hospital for Special Surgery, New York
申办方类型
Other
责任方
Sponsor

研究点 (1)

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