- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00226070
Rehabilitation to Patients Over 65 Years Undergoing THA
Cross-section Study Among Patients Waiting for or Already Undergoing THA Followed by a RCT
Patients over 65 years do not have a self care ability the surgery benefits them.
The aim of this study is development of a rehabilitation program based on patients' self-rated health.
- A cross section study including 600 patients
- RCT including 160 patients
Study Overview
Status
Conditions
Detailed Description
Fase 1: 600 patients waiting for or already having received total hip-/knee-replacement participated in a questionnaire study using SF- 36. The aim was to document self-rated health among this population.
Fase 2: Results from the cross section study form the base for the RCT, where 160 patients over 65 years undergoing THR, 80 patients are in an intervention group and 80 patients in a control group. A nurse intervention program is tested, and results from the study will form the base for a structured rehabilitation program.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Aarhus, Denmark, 8000
- Aarhus University Hospital
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Aarhus, Denmark, 8000
- Kjeld Soballe, Orthopaedic center, University of Aarhus
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Aarhus, Denmark, 8000
- Kjeld Soballe, Orthopaedic Center
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Aarhus, Denmark, 8000
- Orthopaedic Center
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Aarhus, Denmark, 8000
- Ortopaedic center, Aarhus University
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Aarhus, Denmark, 8000
- University of Aarhus, Faculty of Health Sciences, Orthopaedic center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:patients over 65 years undergoing total hip replacement
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Exclusion Criteria:
- patients dropping out
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Selfrated health among the population shows significant dysfunction among patients over 75 years, patient living alone and patients depended on help from others
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Secondary Outcome Measures
Outcome Measure |
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undergoing
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we know next year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kjeld Soballe, MD, Professor, Ortopaedic Center, Aarhus University Hospital, Aarhus Denmark
- Principal Investigator: Kjeld Soballe, Department of Orthopaedics, Aarhus University Hospital, Tage Hansensgade 10, DK-8000 Aarhus C
- Principal Investigator: Kjeld Soballe, MD,DR.Med.,Prof., Aarhus University Hospitak,Ortopaedic center, Aarhus Denmark
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1301500110
- 1999-2-20
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