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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03008967
Other study ID # 2016-41-4783
Secondary ID
Status Completed
Phase N/A
First received September 9, 2016
Last updated January 31, 2018
Start date September 2016
Est. completion date February 2018

Study information

Verified date January 2018
Source Bornholms Regionskommune
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This project will be a descriptive, hypothesis-generating study. The aim is to identify risk factors for poor response to rehabilitation programs after TJR and use these to identify patients who are most susceptible to poor outcomes in order to optimise appropriate rehabilitations strategies and rationalising the distribution of health care resources.


Description:

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Study Design


Intervention

Other:
Arthroplasty and postoperative rehabilitation.
Patients undergoing total knee or total hip arthroplasty and their response to postoperative rehabilitation.

Locations

Country Name City State
Denmark Genoptræningen Rønne Bornholm

Sponsors (1)

Lead Sponsor Collaborator
Bornholms Regionskommune

Country where clinical trial is conducted

Denmark, 

References & Publications (31)

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Outcome

Type Measure Description Time frame Safety issue
Primary 30 second chair stand test, to test the patients functional capacity Change of 30 second chair stand test from baseline to follow up (an average of 3 months)
Secondary Health-related quality of life questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) or Hip disability and Osteoarthritis Outcome Score (HOOS) Change of health-related quality of life questionnaire from baseline to follow up (an average of 3 months)
Secondary Pain catastrophizing scale questionnaire Change of pain catastrophizing scale questionnaire from baseline to follow up (an average of 3 months)
Secondary Use of analgesics and other medication, qualitative assessment Changes in the use og analgesics and other medication from baseline to follow up (an average of 3 months)
Secondary Fall history, events as numbers of falls described by the patient Change within the fall history from baseline to follow up (an average of 3 months)
Secondary Patient expectations questionnaire Preoperative (an average 3 weeks before surgery)
Secondary Patient satisfaction questionnaire At follow up (an average of 3 months postoperative).
Secondary The Forgotten Joint Score questionnaire At follow up (an average of 3 months postoperative).
Secondary Rehabilitation compliance Physiotherapist subjective assessment of patient compliance to the rehabilitation program At the culmination of the rehabilitation program, an average of 10 weeks.
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