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NCT02845960 Clinical Trial

The Influence of Rapid Recovery on Sleep Quality Following Total Knee Replacement Surgery

Arthritis, Rheumatoid Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02845960
Other study ID # Southwest Hospital
Secondary ID
Status Recruiting
Phase N/A
First received July 23, 2016
Last updated July 26, 2016
Start date February 2016

Study information
Verified date July 2016
Source Southwest Hospital, China
Contact WEINAN ZENG, Doctor
Phone +8615023100103
Email weinanzeng@163.com
Is FDA regulated No
Health authority China: Health and Family Planning Commission of Chongqing City
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the influence of rapid recovery on sleep quality following total knee replacement surgery.

Recruitment information / eligibility
Status Recruiting
Enrollment 170
Est. completion date
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 85 Years
Eligibility Inclusion Criteria:

1. Primary unilateral total knee artropasty;

2. Patients with Knee osteoartritis or Rheumatoid arthritis;

3. Able and willing to provide signed informed consent.

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 NSAIDs, opioid analgesics, zolpidem

9. sleep apnea, Parkinson disease, dementia, depression

10. use of sedatives or hypnotics

11. inability to comply with polysomnographic measurement

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Behavioral:
• rapid recovery
rapid recovery

Locations
Country Name City State
China Southwest Hospital Chongqing Chongqing

Sponsors (1)
Lead Sponsor Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary WOMAC score 1 mounth Yes
Primary GAD-7 1 mounth Yes
Primary PSQI index 1 mounth Yes
Primary Insomnia severity index 1 mounth Yes
Primary polysomnographic measurement 1 mounth Yes
Primary VAS 1 mounth Yes
Primary Range of motion 1 mounth Yes
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