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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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29 January 2018 |
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Main ID: |
ChiCTR-INR-16007863 |
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Date of registration:
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2016-01-30 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of high-dose postoperative dexamethasone on pain and recovery after total knee and hip arthroplasty
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Scientific title:
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Effect of high-dose postoperative dexamethasone on pain and recovery after total knee and hip arthroplasty |
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Date of first enrolment:
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2016-02-02 |
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Target sample size:
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High-dose group:50;Multi-dose group:50;Low-dose group:50; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=13292 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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New Treatment Measure Clinical Study
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Countries of recruitment
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China
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Contacts
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Name:
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Li Jinlong
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Address:
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37 Guoxuexiang, Chengdu, Sichuan, China
610041
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Telephone:
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+86 18040350096 |
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Email:
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476825891@qq.com |
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Affiliation:
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Department of Orthopaedics, West China Hospital, Sichuan University |
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Name:
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Zhou Zongke
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Address:
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37 Guoxuexiang, Chengdu, Sichuan, China
610041
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Telephone:
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+86 18980601028 |
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Email:
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zongke@126.com |
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Affiliation:
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Department of Orthopaedics, West China Hospital, Sichuan University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Primary unilateral total knee artropasty;
2. Patients with Knee osteoartritis;
3. Able and willing to provide signed informed consent;
4. the level of IL-1, IL-6, CRP, TNF, ESR, NEUT are normal before surgery.
Exclusion criteria: 1. Simultaneously bilateral total knee artropasty or revision case;
2. Surgical History of the knee joint;
3. Knee joint cavity paracentesis in recent 3 months;
4. Stiffness with knee;
5. Blood coagulation disorders;
6. History of deep venous thrombosis;
7. Concomitant medical problems such as uncontrolled hypertention, severe cardiovascular disorder, chronic obstructive pulmonary disease, liver or renal failure;
8. allergic to dexamethasone;
9. Using adrenal cortical hormone in recent sit months
Age minimum:
22
Age maximum:
72
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hip/knee osteoarthritis
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Intervention(s)
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High-dose group:Dexamethasone administered 10 mg before surgery followed by 20 mg appropriate 4 hours after surgery;Multi-dose group:Dexamethasone administered 10 mg before surgery followed by 10 mg 4 h and 20 h after surgery;Low-dose group:Dexamethasone administered 10 mg before surgery followed by 10 mg 4 h after surgery;
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Primary Outcome(s)
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VAS (0-100);
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Secondary Outcome(s)
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Inflammatory indicators (ESR, CRP, IL-6);Blood transfusion volume;Blood transfusion cases;Hb;Hct;Length of hospital stay;Satisfaction;KOOS;Knee-extension strength;HOOS;5-scale musle score;HSS;KSS;Short-term Complications (SSI);Long-term Complications (Infection);
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Source(s) of Monetary Support
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Ministry of Health Special Scientific Research Projects of China
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Ethics review
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Status: Approved
Approval date: 07/01/2013
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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