ArthroplastyNCT01089946
Cardiovascular Changes and Changes in Tissue Oxygenation During Early Postoperative Mobilization in Total Hip Arthroplasty (THA) Patients
An observational study of Arthroplasty, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the cardiovascular changes during early postoperative mobilization of hip arthroplasty patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2010to Jun 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: Patients undergoing primary THA.
Who may be able to join
- Age > 18 years
- Primary THA
Who cannot join
- Alcoholism
- Known orthostatic hypotension
- Daily use of anxiolytic medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Changes and Changes in Tissue Oxygenation During Early Postoperative Mobilization After Primary Total Hip Arthroplasty
The purpose of this study is to investigate the cardiovascular changes during early postoperative mobilization of hip arthroplasty patients.
- Conditions
- Arthroplasty
- Keywords
- Mobilization, Hip arthroplasty, cardiovascular
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthostatic intolerance
Measured: 6 and 24 hours postoperative
Secondary outcomes (1)
Orthostatic hypotension
Measured: 6 and 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oeivind Jans, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Oeivind Jans, M.D., Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089946
- Sponsor's protocol ID
- RH-4074
- Status last verified
- Oct 2012
- First submitted
- 17 Mar 2010
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Jans O, Bundgaard-Nielsen M, Solgaard S, Johansson PI, Kehlet H. Orthostatic intolerance during early mobilization after fast-track hip arthroplasty. Br J Anaesth. 2012 Mar;108(3):436-43. doi: 10.1093/bja/aer403. Epub 2011 Dec 15.
PubMed 22174345Jans O, Brinth L, Kehlet H, Mehlsen J. Decreased heart rate variability responses during early postoperative mobilization--an observational study. BMC Anesthesiol. 2015 Aug 22;15:120. doi: 10.1186/s12871-015-0099-4.
PubMed 26297144
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Changes and Changes in Tissue Oxygenation During Early Postoperative Mobilization After Primary Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01089946
- Acronym / sponsor ID
- RH-4074
- Conditions
- Arthroplasty
- Keywords
- Mobilization, Hip arthroplasty, cardiovascular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jun 2010 (actual)
- First posted
- 19 Mar 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 investigate the cardiovascular changes during early postoperative mobilization of hip arthroplasty patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing primary THA.
Key inclusion criteria (2 listed)
- Age > 18 years
- Primary THA
Key exclusion criteria (3 listed)
- Alcoholism
- Known orthostatic hypotension
- Daily use of anxiolytic medication
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
Orthostatic intolerance
Time frame: 6 and 24 hours postoperative
1 secondary outcome
Orthostatic hypotension
Time frame: 6 and 24 hours postoperative
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 10 Oct 2012.
- Results publication: PubMed 22174345Jans O, Bundgaard-Nielsen M, Solgaard S, Johansson PI, Kehlet H. Orthostatic intolerance during early mobilization after fast-track hip arthroplasty. Br J Anaesth. 2012 Mar;108(3):436-43. doi: 10.1093/bja/aer403. Epub 2011 Dec 15.
- Derived from this study: PubMed 26297144Jans O, Brinth L, Kehlet H, Mehlsen J. Decreased heart rate variability responses during early postoperative mobilization--an observational study. BMC Anesthesiol. 2015 Aug 22;15:120. doi: 10.1186/s12871-015-0099-4.
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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.
Oeivind Jans, M.D. principal investigator
Copenhagen University Hospital, Rigshospitalet
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, run by Copenhagen University Hospital, Rigshospitalet 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 2 inclusion and 3 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 10 Oct 2012. 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?
Orthostatic intolerance (time frame: 6 and 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01089946, which also lists 2 linked publications.
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 10 Oct 2012.