- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01246674
Thigh Swelling, Hip-muscle Strength, and Functional Performance Following Total Hip Arthroplasty (THA)
July 18, 2012 updated by: Bente Holm, Hvidovre University Hospital
Thigh Swelling, Hip-muscle Strength, and Functional Performance Following Total Hip Arthroplasty Monitored Pre-operatively, on the Day of Discharge, and One Week Post-surgery
By this study the investigators wish to (1) quantify hip strength and functional-performance deficits at discharge after fast-track total hip arthroplasty (THA), and (2) investigate if changes in thigh circumferences, or hip pain are correlated to changes in hip strength and functional-performance after fast-track THA.
Study Overview
Status
Completed
Detailed Description
The investigators intend to use the results to optimize the rehabilitation programs for THA patients shortly after surgery
Study Type
Observational
Enrollment (Actual)
30
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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Hvidovre, Denmark, 2650
- Dep. of Physical Therapy, Copenhagen University Hospital at Hvidovre
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
from a department of orthopedic surgery
Description
Inclusion Criteria:
- Total hip arthroplasty patients
Exclusion Criteria:
- inability to speak and understand Danish
- inability to perform the functional measurements due to other conditions
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
Cohorts and Interventions
Group / Cohort |
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Hypothesis generating study
Consecutive total hip arthroplasty patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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hip muscles strength
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional performance
Time Frame: 6 months
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tested by: Timed Up & Go test, 10 meter fast speed walking
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Bente Holm, MSc, The Lundbeckcenter for hip and knee surgery, University Hospital at Hvidovre, Kettegaard Alle 30, DK-2650 Hvidovre Denmark
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Holm B, Kristensen MT, Bencke J, Husted H, Kehlet H, Bandholm T. Loss of knee-extension strength is related to knee swelling after total knee arthroplasty. Arch Phys Med Rehabil. 2010 Nov;91(11):1770-6. doi: 10.1016/j.apmr.2010.07.229.
- Holm B, Thorborg K, Husted H, Kehlet H, Bandholm T. Surgery-induced changes and early recovery of hip-muscle strength, leg-press power, and functional performance after fast-track total hip arthroplasty: a prospective cohort study. PLoS One. 2013 Apr 16;8(4):e62109. doi: 10.1371/journal.pone.0062109. Print 2013.
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
January 1, 2011
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
November 22, 2010
First Submitted That Met QC Criteria
November 22, 2010
First Posted (Estimate)
November 23, 2010
Study Record Updates
Last Update Posted (Estimate)
July 19, 2012
Last Update Submitted That Met QC Criteria
July 18, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-4-2010-FSP
- THA-BH2 (Registry Identifier: H-4-2010-FSP)
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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