Arthroplasty, Hip ReplacementNCT01514006
Postoperative Anemia and Functional Outcomes After Fast-track Primary Hip Arthroplasty
An observational study of Arthroplasty, Hip Replacement and Anemia, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
The purpose of this study is to evaluate the possible association between postoperative anaemia and functional outcomes the first 2 weeks after primary hip arthroplasty. The investigators hypothesise that patients with a higher degree of postoperative anaemia have impaired postoperative rehabilitation as measured by… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Arthroplasty, Hip Replacement, Anemia
- How many people
- 125 participants
- Where
- 2 sitesDenmark
- Study dates
- Jan 2012to Aug 2013
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All patients aged 65 or above undergoing primary hip arhtroplasty
Who may be able to join
- Patients undergoing primary unilateral THA
- Age 65 or older
Who cannot join
- Not able to give consent
- Not able to walk prior to surgery
- Chronic need for RBC transfusion
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Gentofte Hospital, Department of orthopedic surgery
Gentofte Municipality
Vejle Sygehus, Department of orthopedic surgery
Vejle
About this study
Official title: Postoperative Anemia and Functional Outcomes After Fast-track Primary Hip Arthroplasty - a Prospective Observational Study
The purpose of this study is to evaluate the possible association between postoperative anaemia and functional outcomes the first 2 weeks after primary hip arthroplasty.
The investigators hypothesise that patients with a higher degree of postoperative anaemia have impaired postoperative rehabilitation as measured by standardized functional outcome tests.
Read the detailed description
Postoperative anemia may impair postoperative rehabilitation due to anemia related symptoms such as fatigue or dizziness. Although, the impact of postoperative anemia on postoperative rehabilitation and function has previously been examined the results are conflicting.
Patients undergoing fast-track hip arthroplasty (THA) are mobilized early and participate in physiotherapy during the admission but are discharged early (2-3) days postoperative. However, the ability to rehabilitate early after discharge has not been evaluated in relation to postoperative anemia.
The purpose of this observational study is to evaluate the possible association between postoperative anaemia and functional outcomes the first 2 weeks after primary hip arthroplasty.
The investigators hypothesise that patients with a higher degree of postoperative anaemia have impaired postoperative rehabilitation as measured by standardized functional outcome tests. Hb concentrations and functional outcome measurements will be performed preoperatively, at the day of hospital discharge and during a postoperative visit 12-16 days after surgery.
- Conditions
- Arthroplasty, Hip Replacement, Anemia
- Keywords
- Primary hip arthroplasty, postoperative anemia, functional outcomes
- Medical subject headings
- Anemia
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 |
|---|---|---|
| Study Cohort | Patients, aged 65 or above, undergoing elective primary unilateral hip arthroplasty in a fast-track setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute walking test (6MWT)
6MWT is a standardized functional test which determines the walking distance covered during a timed period of 6 minutes.
Measured: 2 weeks after surgery
Secondary outcomes (3)
FACT-Anemia Scale
FACT-Anemia scale is a validated questionare based score addressing anaemia related symptoms.
Measured: 2 weeks after surgery
Timed up and go test (TUG)
Measured: 2 weeks after surgery
At home activity by ActivPal
Activity measures using accelerometer based activity monitor
Measured: 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Hip ReplacementStudies 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
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen, Vejle Hospital
- Responsible party
- Principal investigator, Oeivind Jans, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Oeivind Jans, MD., Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514006
- Sponsor's protocol ID
- H-4-2011-117
- Status last verified
- Mar 2015
- First submitted
- 17 Jan 2012
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Anemia and Functional Outcomes After Fast-track Primary Hip Arthroplasty - a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT01514006
- Acronym / sponsor ID
- H-4-2011-117
- Conditions
- Arthroplasty, Hip Replacement, Anemia
- Keywords
- Primary hip arthroplasty, postoperative anemia, functional outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen, Vejle Hospital
- Study start
- Jan 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 Jan 2012 (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 possible association between postoperative anaemia and functional outcomes the first 2 weeks after primary hip arthroplasty.
The investigators hypothesise that patients with a higher degree of postoperative anaemia have impaired postoperative rehabilitation as measured by standardized functional outcome tests.
Detailed description
Postoperative anemia may impair postoperative rehabilitation due to anemia related symptoms such as fatigue or dizziness. Although, the impact of postoperative anemia on postoperative rehabilitation and function has previously been examined the results are conflicting.
Patients undergoing fast-track hip arthroplasty (THA) are mobilized early and participate in physiotherapy during the admission but are discharged early (2-3) days postoperative. However, the ability to rehabilitate early after discharge has not been evaluated in relation to postoperative anemia.
The purpose of this observational study is to evaluate the possible association between postoperative anaemia and functional outcomes the first 2 weeks after primary hip arthroplasty.
The investigators hypothesise that patients with a higher degree of postoperative anaemia have impaired postoperative rehabilitation as measured by standardized functional outcome tests. Hb concentrations and functional outcome measurements will be performed preoperatively, at the day of hospital discharge and during a postoperative visit 12-16 days after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | –Patients, aged 65 or above, undergoing elective primary unilateral hip arthroplasty in a fast-track setting. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients aged 65 or above undergoing primary hip arhtroplasty
Key inclusion criteria (2 listed)
- Patients undergoing primary unilateral THA
- Age 65 or older
Key exclusion criteria (3 listed)
- Not able to give consent
- Not able to walk prior to surgery
- Chronic need for RBC transfusion
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
6 Minute walking test (6MWT)
Time frame: 2 weeks after surgery
6MWT is a standardized functional test which determines the walking distance covered during a timed period of 6 minutes.
3 secondary outcomes
FACT-Anemia Scale
Time frame: 2 weeks after surgery
Timed up and go test (TUG)
Time frame: 2 weeks after surgery
At home activity by ActivPal
Time frame: 1 week after surgery
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 9 Mar 2015.
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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, MD. principal investigator
Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, Hip Replacement and Anemia, run by Copenhagen University Hospital, Rigshospitalet at 2 sites 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 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
6 Minute walking test (6MWT) (time frame: 2 weeks after surgery). 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 9 Mar 2015.