The Influence of Rapid Recovery on Sleep Quality Following Total Hip Replacement Surgery
1 other identifier
interventional
170
1 country
1
Brief Summary
To evaluate the influence of rapid recovery on sleep quality following total hip replacement surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 24, 2016
CompletedFirst Posted
Study publicly available on registry
August 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedAugust 2, 2016
July 1, 2016
5 months
July 24, 2016
July 28, 2016
Conditions
Outcome Measures
Primary Outcomes (6)
To evaluate the pain, stiffness and joint function of operated limb by McMaster Universities Osteoarthritis Index(WOMAC)
To evaluate the function and structure of hip joint from the aspect of pain, stiffness and joint function
6 months
To evaluate the anxiety of patients post-operation by Generalized Anxiety Disorder scale-7 (GAD-7)
6 months
To evaluate the sleep quality of patients post-operation by Pittsburgh Sleep Quality Index (PSQI)
6 months
Insomnia severity index
6 months
To evaluate the health related quality of life of patients post-operation by the 12-items Short Form Health Survey (SF-12)
6 months
To evaluate the pain severity of patients post-operation by Visual Analogue Scale (VAS) Pain Score
6 months
Secondary Outcomes (13)
C Reactive Protein (CRP)
6 months
Erythrocyte Sedimentation Rate (ESR)
6 months
To evaluate the quadriceps strength according to grade division standard published by British Medical Research Council
6 months
To evaluate the swelling of operated limb by measure the thigh girth increment
6 months
To evaluate the operation satisfaction of patients by Visual Analogue Scale (VAS) Satisfaction Score
6 months
- +8 more secondary outcomes
Study Arms (2)
Experimental group
EXPERIMENTALrapid recovery
Controlled group
NO INTERVENTIONnon-rapid recovery
Interventions
Eligibility Criteria
You may qualify if:
- \. Primary unilateral total hip arthroplasty;
- \. Patients with hip osteoarthritis,rheumatoid arthritis or femoral head necrosis;
- \. Able and willing to provide signed informed consent.
You may not qualify if:
- \. Simultaneously bilateral total hip arthroplasty or revision case;
- \. Surgical History of the hip joint;
- \. Hip joint cavity paracentesis in recent 3 months;
- \. Stiffness with hip;
- \. Blood coagulation disorders;
- \. History of deep venous thrombosis;
- \. Concomitant medical problems such as uncontrolled hypertension, severe cardiovascular disorder, chronic obstructive pulmonary disease, liver or renal failure
- \. Allergic to NSAIDs, opioid analgesics, zolpidem
- \. Sleep apnea, Parkinson disease, dementia, depression
- \. Use of sedatives or hypnotics
- \. Unable to comply with polysomnographic measurement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southwest Hospital
Chongqing, Chongqing Municipality, 400038, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 24, 2016
First Posted
August 2, 2016
Study Start
April 1, 2016
Primary Completion
September 1, 2016
Last Updated
August 2, 2016
Record last verified: 2016-07