Arthroplasty, Replacement, KneeNCT02845960
The Influence of Rapid Recovery on Sleep Quality Following Total Knee Replacement Surgery
An observational study of Arthroplasty, Replacement, Knee and Recovery of Function, run by Southwest Hospital, China at 1 site in China.
Trial summary
The purpose of this study is to evaluate the influence of rapid recovery on sleep quality following total knee replacement surgery. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Recovery of Function, Arthritis, Rheumatoid
- What is being tested?
- rapid recovery
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Aug 2017
- Phase
- Observational
- 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
Study population: Chinese
Who may be able to join
- Primary unilateral total knee artropasty;
- Patients with Knee osteoartritis or Rheumatoid arthritis;
- Able and willing to provide signed informed consent.
Who cannot join
- Simultaneously bilateral total knee artropasty or revision case;
- Surgical History of the knee joint;
- Knee joint cavity paracentesis in recent 3 months;
- Stiffness with knee;
- Blood coagulation disorders;
- History of deep venous thrombosis;
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- Concomitant medical problems such as uncontrolled hypertention, 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
- inability 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
The purpose of this study is to evaluate the influence of rapid recovery on sleep quality following total knee replacement surgery.
- Being tested
- rapid recovery
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapid recoveryBehavioural
rapid recovery
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | rapid recovery Receives: Behavioral: rapid recovery | |
| Controlled group | no rapid recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC score
Measured: 1 mounth
GAD-7
Measured: 1 mounth
PSQI index
Measured: 1 mounth
Insomnia severity index
Measured: 1 mounth
polysomnographic measurement
Measured: 1 mounth
VAS
Measured: 1 mounth
Range of motion
Measured: 1 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- 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
- NCT02845960
- Sponsor's protocol ID
- Southwest Hospital
- Status last verified
- Jul 2016
- First submitted
- 23 Jul 2016
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 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 Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT02845960
- Acronym / sponsor ID
- Southwest Hospital
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Aug 2017 (estimated)
- First posted
- 27 Jul 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.
The purpose of this study is to evaluate the influence of rapid recovery on sleep quality following total knee replacement surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Behavioral: rapid recoveryrapid recovery |
| Controlled group | – | –no rapid recovery |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese
Key inclusion criteria (3 listed)
- Primary unilateral total knee artropasty;
- Patients with Knee osteoartritis or Rheumatoid arthritis;
- Able and willing to provide signed informed consent.
Key exclusion criteria (11 listed)
- Simultaneously bilateral total knee artropasty or revision case;
- Surgical History of the knee joint;
- Knee joint cavity paracentesis in recent 3 months;
- Stiffness with knee;
- 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 recoveryrapid recovery | Behavioural | Experimental group |
Primary outcome
WOMAC score
Time frame: 1 mounth
GAD-7
Time frame: 1 mounth
PSQI index
Time frame: 1 mounth
Insomnia severity index
Time frame: 1 mounth
polysomnographic measurement
Time frame: 1 mounth
VAS
Time frame: 1 mounth
Range of motion
Time frame: 1 mounth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
- Individual participant dataSharing planned: No
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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?
An observational study of Arthroplasty, Replacement, Knee 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 27 Jul 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, Doctor (+8615023100103, weinanzeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC score (time frame: 1 mounth). The study lists 7 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 27 Jul 2016.