PainNCT01047371
Why in Hospital - Factors Determining Time to Discharge Readiness After Arthroplasty Surgery
An observational study of Pain and Nausea, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate patient related factors determining length of stay in hospital after arthroplasty surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2010to Aug 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients scheduled for total hip or knee arthroplasty
Who may be able to join
- Patients scheduled for total hip or knee arthroplasty
Who cannot join
- Age under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Why in Hospital - Factors Determining Time to Discharge Readiness After Arthroplasty Surgery: An Prospective Observational Study
The purpose of this study is to evaluate patient related factors determining length of stay in hospital after arthroplasty surgery.
Read the detailed description
To evaluate why the patient is in hospital after surgery, when predefined discharge criteria are met, which patient related clinical problems hinder fulfilling of the discharge criteria, and to evaluate actual length of stay in hospital.
All consecutive patients scheduled for total hip or knee arthroplasty are included in the trial.
- Medical subject headings
- Pain, Nausea, Vomiting, Dizziness, Fatigue, Epilepsy, Rolandic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Osteoarthrosis | All consecutive patients scheduled for total hip or knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient related factors determining length of stay in hospital
Measured: Daily (average 2 days)
Secondary outcomes (2)
Length of stay in hospital
Measured: At discharge (average 2 days)
Time till fulfilling of predefined discharge criteria
Measured: At discharge (average 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation
- Responsible party
- Principal investigator, Troels Haxholdt Lunn, Hvidovre University Hospital
- Investigators
- Henrik Husted, MD, Study director, Hvidovre University HospitalTroels H. Lunn, M.D, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047371
- Sponsor's protocol ID
- 1234
- Other IDs
- 5678
- Status last verified
- Sep 2011
- First submitted
- 11 Jan 2010
- Last updated
- 29 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Why in Hospital - Factors Determining Time to Discharge Readiness After Arthroplasty Surgery: An Prospective Observational Study
- ClinicalTrials.gov ID
- NCT01047371
- Acronym / sponsor ID
- 1234
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Lundbeck Foundation
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 12 Jan 2010 (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 patient related factors determining length of stay in hospital after arthroplasty surgery.
Detailed description
To evaluate why the patient is in hospital after surgery, when predefined discharge criteria are met, which patient related clinical problems hinder fulfilling of the discharge criteria, and to evaluate actual length of stay in hospital.
All consecutive patients scheduled for total hip or knee arthroplasty are included in the trial.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Osteoarthrosis | – | –All consecutive patients scheduled for total hip or knee arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients scheduled for total hip or knee arthroplasty
Key inclusion criteria (1 listed)
- Patients scheduled for total hip or knee arthroplasty
Key exclusion criteria (1 listed)
- Age under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient related factors determining length of stay in hospital
Time frame: Daily (average 2 days)
2 secondary outcomes
Length of stay in hospital
Time frame: At discharge (average 2 days)
Time till fulfilling of predefined discharge criteria
Time frame: At discharge (average 2 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2011.
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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.
Henrik Husted, MD study director
Hvidovre University Hospital
Troels H. Lunn, M.D principal investigator
Hvidovre University Hospital
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 Pain and Nausea, run by Hvidovre University Hospital at 1 site in Denmark.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Sep 2011. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient related factors determining length of stay in hospital (time frame: Daily (average 2 days)). 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 29 Sep 2011.