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

• Conditions: Arthritis, Rheumatoid; Arthroplasty, Replacement, Knee; Recovery of Function

• Registration Number: NCT02845960
• Lead Sponsor: Southwest Hospital, China

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Status Verified: 2016-07
• Study First Submitted: 2016-07-23
• Study First Submitted QC: 2016-07-26
• Last Update Submitted: 2016-07-26
• Study First Posted: 2016-07-27
• Last Update Posted: 2016-07-27
• Primary Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PSQI index	1 mounth
Insomnia severity index	1 mounth
VAS	1 mounth
GAD-7	1 mounth
polysomnographic measurement	1 mounth
WOMAC score	1 mounth
Range of motion	1 mounth

Trial Locations

Locations (1)

Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China