- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02137655
Recovery After Fast Track THA / TKA (0-21)
March 8, 2016 updated by: Eske Kvanner Aasvang, Rigshospitalet, Denmark
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
112
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Region hovedstaden
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Gentofte, Region hovedstaden, Denmark, 2820
- Gentofte Hospital
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Region syd
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Vejle, Region syd, Denmark, 7100
- Vejle Sygehus
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with hip or knee osteoarthritis referred for total joint arthroplasty.
Description
Inclusion Criteria:
- Primary total hip or knee arthroplasty
- Age 55 to 80 years
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: 48 hours postoperatively
|
VAS when walking
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48 hours postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
May 12, 2014
First Submitted That Met QC Criteria
May 13, 2014
First Posted (Estimate)
May 14, 2014
Study Record Updates
Last Update Posted (Estimate)
March 9, 2016
Last Update Submitted That Met QC Criteria
March 8, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-3-2014-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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