Short-term Efficacy of Antidepressant in Patients Underwent TKA

Study Overview
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Brief Summary
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By taking certain antidepressant in early postoperative period，which is supposed to improve the psychological status of patients with osteoarthritis, explore the effect of certain antidepressant on the recovery of the early stage after the operation of knee joint replacement.

Detailed Description
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In this study, the investigators are going to investigate the efficacy of Duloxetine on pain, physical function, mental health and quality of life in patients underwent TKAs. The control group is going to be given celecoxib 200mg/24h to 2 weeks after operation.On the basis of the above scheme, the treatment group is going to receiving duloxetine 60mg/24h to 8 weeks after operation.HAMD-17 scale, KSS scale, SF-36 scale and WOMAC scale will be used to evaluate the two groups before and after operation for 4 and 8 weeks.

Conditions
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Osteoarthritis Of Knee

Intervention / Treatment
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* Drug: Duloxetine Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No extra articular malformations are diagnosed and accord with Kellgren-Lawrence criteria Primary TKA surgery,Varus is smaller than 20° Always there is no history of mental illness, no history of relevant medicine Be able to read and understand Chinese, with good communication skills Voluntary participation in this clinical study Exclusion Criteria: Previous history of mental and psychological illness With severe diseases in respiratory system, circulatory system or digestive system Allergic to duloxetine and celecoxib

Ages Eligible for Study
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Minimum Age: 51 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All patients will be randomly divided into two groups. The control group is going to be given celecoxib 200mg/24h to 2 weeks after operation. On the basis of the above scheme, the The treatment group will receive duloxetine 60mg/24h to 8 weeks after operation.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: KSS scale<br>Knee Society Score with Duloxetine Hydrochloride | Drug: Duloxetine Hydrochloride<br>* The treatment group will receive duloxetine 60mg/24h to 8 weeks after operation<br>* Other names: Cymbalta;|
| Active Comparator: HAMD-17 scale<br>Hamilton Depression Score with Duloxetine Hydrochloride | Drug: Duloxetine Hydrochloride<br>* The treatment group will receive duloxetine 60mg/24h to 8 weeks after operation<br>* Other names: Cymbalta;|
| Active Comparator: SF-36 scale<br>Medical Outcomes Study Short Form-36 score with Duloxetine Hydrochloride | Drug: Duloxetine Hydrochloride<br>* The treatment group will receive duloxetine 60mg/24h to 8 weeks after operation<br>* Other names: Cymbalta;|
| Active Comparator: WOMAC scale<br>Western Ontario and McMaster Universities Index with Duloxetine Hydrochloride | Drug: Duloxetine Hydrochloride<br>* The treatment group will receive duloxetine 60mg/24h to 8 weeks after operation<br>* Other names: Cymbalta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score of participants with Duloxetine as assessed by Western Ontario and McMaster Universities Index after 4 weeks of treatment. | A face-to-face questionnaire will be conducted by two trained interviewers | up to 6 months | 
| Function score of participants with Duloxetine as assessed by Knee Society Score after 4 weeks of treatment. | A face-to-face questionnaire will be conducted by two trained interviewers | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score of participants with Duloxetine as assessed by Western Ontario and McMaster Universities Index after 8 weeks of treatment. | A face-to-face questionnaire will be conducted by two trained interviewers | up to 6 months | 
| Function score of participants with Duloxetine as assessed by Knee Society Score after 8 weeks of treatment. | A face-to-face questionnaire will be conducted by two trained interviewers | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Osteoarthritis, Depression