Arthroplasty, Recovery of Function, Sleep Quality
Conditions
Brief summary
To evaluate the influence of rapid recovery on sleep quality following total hip replacement surgery
Interventions
OTHERrapid recovery
Sponsors
Southwest Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Primary unilateral total hip arthroplasty; * 2\. Patients with hip osteoarthritis,rheumatoid arthritis or femoral head necrosis; * 3\. Able and willing to provide signed informed consent.
Exclusion criteria
* 1\. Simultaneously bilateral total hip arthroplasty or revision case; * 2\. Surgical History of the hip joint; * 3\. Hip joint cavity paracentesis in recent 3 months; * 4\. Stiffness with hip; * 5\. Blood coagulation disorders; * 6\. History of deep venous thrombosis; * 7\. Concomitant medical problems such as uncontrolled hypertension, 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\. Unable to comply with polysomnographic measurement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the pain, stiffness and joint function of operated limb by McMaster Universities Osteoarthritis Index(WOMAC) | 6 months | To evaluate the function and structure of hip joint from the aspect of pain, stiffness and joint function |
| 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
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the range of motion (ROM) of operated hip | 6 months | ROM of operated hips post-operation |
| Length of hospital stay | 3 months | — |
| Number of dressing changes | 1 month | Number of dressing changes post-operation |
| C Reactive Protein (CRP) | 6 months | — |
| Haemoglobin | 6 months | Pre-operation and post-operation haemoglobin |
| Number of Blood transfusion cases | 1 month | — |
| Blood transfusion volume | 1 month | — |
| Hematocrit | 6 months | Pre-operation and post-operation hematocrit |
| 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 | Calculated by operated limb thigh girth increment post-operation |
| To evaluate the operation satisfaction of patients by Visual Analogue Scale (VAS) Satisfaction Score | 6 months | — |
| To evaluate the function of operated limb by Harris hip score (HHS) | 6 months | — |
Countries
China
Contacts
Primary ContactWEINAN ZENG
Outcome results
None listed