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NCT00226070 Clinical Trial

Rehabilitation to Patients Over 65 Years Undergoing THA

Hip Arthroplasty Clinical Trial

Official title:
Cross-section Study Among Patients Waiting for or Already Undergoing THA Followed by a RCT

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00226070
Other study ID # 1301500110
Secondary ID 1999-2-20
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date January 2, 2005
Est. completion date April 20, 2010

Study information
Verified date December 2022
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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. 1. A cross section study including 600 patients 2. RCT including 160 patients

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.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date April 20, 2010
Est. primary completion date March 31, 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 95 Years
Eligibility Inclusion Criteria:patients over 65 years undergoing total hip replacement - Exclusion Criteria: - patients dropping out

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• interview and advising

Behavioral:
• 3 follow up interviews and personal advising

Procedure:
• interview SF-36 self rated health

Locations
Country Name City State
Denmark Aarhus University Hospital Aarhus
Denmark Kjeld Soballe, Orthopaedic Center Aarhus
Denmark Kjeld Soballe, Orthopaedic center, University of Aarhus Aarhus
Denmark Orthopaedic Center Aarhus
Denmark Ortopaedic center, Aarhus University Aarhus
Denmark University of Aarhus, Faculty of Health Sciences, Orthopaedic center Aarhus

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Selfrated health among the population shows significant dysfunction among patients over 75 years, patient living alone and patients depended on help from others
Secondary undergoing
Secondary we know next year
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