Hip and Knee Osteoarthritis0-21NCT02137655
Recovery After Fast Track THA / TKA
An observational study of Hip and Knee Osteoarthritis, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
The development and implementation of "fast-track" principles in total knee and hip arthroplasty have resulted in early recovery and rehabilitation alongside a reduced length of hospital stay. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Hip and Knee Osteoarthritis
- How many people
- 112 participants
- Where
- 2 sitesDenmark
- Study dates
- May 2014to Feb 2016
- 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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hip or knee osteoarthritis referred for total joint arthroplasty.
Who may be able to join
- Primary total hip or knee arthroplasty
- Age 55 to 80 years
Who cannot join
- Deficient written or spoken danish
- Alcohol abuse (>21 U per week)
- Immunocompromised
- Anticoagulant therapy
- ASA class 4-5
- Functional impairment from psychological or neurological disease
- Sleepapnea
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Gentofte hospital
Gentofte Municipality, Capital Region, 2820
Vejle Sygehus
Vejle, Region Syd, 7100
About this study
Official title: Prospective Descripive Study of Subacute Function After Total Hip or Knee Arthroplasty
The development and implementation of "fast-track" principles in total knee and hip arthroplasty have resulted in early recovery and rehabilitation alongside a reduced length of hospital stay. This without a concomitant increase in morbidity or readmissions for medical or surgical complications and with reduced mortality. However, only little is known about function in the subacute period after arthroplasty, and there is a need for further data on physical and psychological functioning following discharge from hospital.This to ensure, that the positive results from the perioperative setting are carried forward in the subacute phase.
Read the detailed description
Data will be published in three papers:
- "Physical function and related factors following discharge from THA and TKA" Luna IE, Kehlet H, Aasvang EK.
- "Postoperative hypoxemia following fast-track hip and knee arthroplasty" Luna IE, Kehlet H, Aasvang EK.
- "Cognitive dysfunction after fast-track hip- and knee arthroplasty - prevalence and related factors". Luna IE, Kehlet H, Aasvang EK.
- Conditions
- Hip and Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
VAS when walking
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip and Knee OsteoarthritisStudies 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
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation
- Responsible party
- Principal investigator, Eske Kvanner Aasvang, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137655
- Sponsor's protocol ID
- H-3-2014-005
- Acronym
- 0-21
- Status last verified
- Mar 2016
- First submitted
- 12 May 2014
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Descripive Study of Subacute Function After Total Hip or Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02137655
- Acronym / sponsor ID
- 0-21 / H-3-2014-005
- Conditions
- Hip and Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Lundbeck Foundation
- Study start
- May 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 14 May 2014 (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 development and implementation of "fast-track" principles in total knee and hip arthroplasty have resulted in early recovery and rehabilitation alongside a reduced length of hospital stay. This without a concomitant increase in morbidity or readmissions for medical or surgical complications and with reduced mortality. However, only little is known about function in the subacute period after arthroplasty, and there is a need for further data on physical and psychological functioning following discharge from hospital.This to ensure, that the positive results from the perioperative setting are carried forward in the subacute phase.
Detailed description
Data will be published in three papers:
- "Physical function and related factors following discharge from THA and TKA" Luna IE, Kehlet H, Aasvang EK.
- "Postoperative hypoxemia following fast-track hip and knee arthroplasty" Luna IE, Kehlet H, Aasvang EK.
- "Cognitive dysfunction after fast-track hip- and knee arthroplasty - prevalence and related factors". Luna IE, Kehlet H, Aasvang EK.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hip or knee osteoarthritis referred for total joint arthroplasty.
Key inclusion criteria (2 listed)
- Primary total hip or knee arthroplasty
- Age 55 to 80 years
Key exclusion criteria (7 listed)
- Deficient written or spoken danish
- Alcohol abuse (>21 U per week)
- Immunocompromised
- Anticoagulant therapy
- ASA class 4-5
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
Pain
Time frame: 48 hours postoperatively
VAS when walking
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 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hip and Knee Osteoarthritis, 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 7 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 2016. 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?
Pain (time frame: 48 hours postoperatively). 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 2016.