ArthroplastyNCT02852460
The Influence of Rapid Recovery on Sleep Quality Following Total Hip Replacement Surgery
A study testing rapid recovery in people with Arthroplasty and Recovery of Function, run by Southwest Hospital, China at 1 site in China.
Trial summary
To evaluate the influence of rapid recovery on sleep quality following total hip replacement surgery Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Arthroplasty, Recovery of Function, Sleep Quality
- What is being tested?
- rapid recovery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southwest Hospital
Chongqing, Chongqing Municipality, 400038
Weinan Zeng, doctor, +8615023100103, weinanzeng@163.com
About this study
To evaluate the influence of rapid recovery on sleep quality following total hip replacement surgery
- Conditions
- Arthroplasty, Recovery of Function, Sleep Quality
- Being tested
- rapid recovery
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapid recoveryOther
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | rapid recovery Receives: Other: rapid recovery |
| Controlled group | No intervention | non-rapid recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
To evaluate the anxiety of patients post-operation by Generalized Anxiety Disorder scale-7 (GAD-7)
Measured: 6 months
To evaluate the sleep quality of patients post-operation by Pittsburgh Sleep Quality Index (PSQI)
Measured: 6 months
Insomnia severity index
Measured: 6 months
To evaluate the health related quality of life of patients post-operation by the 12-items Short Form Health Survey (SF-12)
Measured: 6 months
To evaluate the pain severity of patients post-operation by Visual Analogue Scale (VAS) Pain Score
Measured: 6 months
Secondary outcomes (13)
C Reactive Protein (CRP)
Measured: 6 months
Erythrocyte Sedimentation Rate (ESR)
Measured: 6 months
To evaluate the quadriceps strength according to grade division standard published by British Medical Research Council
Measured: 6 months
To evaluate the swelling of operated limb by measure the thigh girth increment
Calculated by operated limb thigh girth increment post-operation
Measured: 6 months
To evaluate the operation satisfaction of patients by Visual Analogue Scale (VAS) Satisfaction Score
Measured: 6 months
To evaluate the function of operated limb by Harris hip score (HHS)
Measured: 6 months
To evaluate the range of motion (ROM) of operated hip
ROM of operated hips post-operation
Measured: 6 months
Length of hospital stay
Measured: 3 months
Number of dressing changes
Number of dressing changes post-operation
Measured: 1 month
Hematocrit
Pre-operation and post-operation hematocrit
Measured: 6 months
Haemoglobin
Pre-operation and post-operation haemoglobin
Measured: 6 months
Number of Blood transfusion cases
Measured: 1 month
Blood transfusion volume
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Yang, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852460
- Sponsor's protocol ID
- Rapid recovery
- Status last verified
- Jul 2016
- First submitted
- 24 Jul 2016
- Last updated
- 2 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Rapid Recovery on Sleep Quality Following Total Hip Replacement Surgery
- ClinicalTrials.gov ID
- NCT02852460
- Acronym / sponsor ID
- Rapid recovery
- Conditions
- Arthroplasty, Recovery of Function, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Sep 2016 (estimated)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the influence of rapid recovery on sleep quality following total hip replacement surgery
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: rapid recoveryrapid recovery |
| Controlled group | No intervention | –non-rapid recovery |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rapid recovery | Other | Experimental group |
Primary outcome
To evaluate the pain, stiffness and joint function of operated limb by McMaster Universities Osteoarthritis Index(WOMAC)
Time frame: 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)
Time frame: 6 months
To evaluate the sleep quality of patients post-operation by Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 months
Insomnia severity index
Time frame: 6 months
To evaluate the health related quality of life of patients post-operation by the 12-items Short Form Health Survey (SF-12)
Time frame: 6 months
To evaluate the pain severity of patients post-operation by Visual Analogue Scale (VAS) Pain Score
Time frame: 6 months
13 secondary outcomes
C Reactive Protein (CRP)
Time frame: 6 months
Erythrocyte Sedimentation Rate (ESR)
Time frame: 6 months
To evaluate the quadriceps strength according to grade division standard published by British Medical Research Council
Time frame: 6 months
To evaluate the swelling of operated limb by measure the thigh girth increment
Time frame: 6 months
To evaluate the operation satisfaction of patients by Visual Analogue Scale (VAS) Satisfaction Score
Time frame: 6 months
To evaluate the function of operated limb by Harris hip score (HHS)
Time frame: 6 months
To evaluate the range of motion (ROM) of operated hip
Time frame: 6 months
Length of hospital stay
Time frame: 3 months
Number of dressing changes
Time frame: 1 month
Hematocrit
Time frame: 6 months
Haemoglobin
Time frame: 6 months
Number of Blood transfusion cases
Time frame: 1 month
Blood transfusion volume
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rapid recovery in people with Arthroplasty and Recovery of Function, run by Southwest Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact WEINAN ZENG (+8615023100103, weinanzeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the pain, stiffness and joint function of operated limb by McMaster Universities Osteoarthritis Index(WOMAC) (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2016.