Short-term Efficacy of Antidepressant in Patients Underwent TKA

Dalian Municipal Central Hospital

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Osteoarthritis Of Knee

Treatments: Drug: Duloxetine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03110172

I84412001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 51 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. No extra articular malformations are diagnosed and accord with Kellgren-Lawrence criteria
2. Primary TKA surgery,Varus is smaller than 20°
3. Always there is no history of mental illness, no history of relevant medicine
4. Be able to read and understand Chinese, with good communication skills
5. Voluntary participation in this clinical study

Exclusion criteria

1. Previous history of mental and psychological illness
2. With severe diseases in respiratory system, circulatory system or digestive system
3. Allergic to duloxetine and celecoxib

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 4 patient groups

KSS scale

Active Comparator group

Description:

Knee Society Score with Duloxetine Hydrochloride

Treatment:

Drug: Duloxetine Hydrochloride

HAMD-17 scale

Active Comparator group

Description:

Hamilton Depression Score with Duloxetine Hydrochloride

Treatment:

Drug: Duloxetine Hydrochloride

SF-36 scale

Active Comparator group

Description:

Medical Outcomes Study Short Form-36 score with Duloxetine Hydrochloride

Treatment:

Drug: Duloxetine Hydrochloride

WOMAC scale

Active Comparator group

Description:

Western Ontario and McMaster Universities Index with Duloxetine Hydrochloride

Treatment:

Drug: Duloxetine Hydrochloride