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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 October 2012 |
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Main ID: |
NCT01410409 |
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Date of registration:
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02/08/2011 |
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Primary sponsor: |
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Public title:
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Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement
MEDIC |
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Scientific title:
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Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement. A Randomized Controlled Trial of Pain, Physical Function and Quality of Life With 12months Follow-up |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01410409 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Søren T Skou, PhD-student |
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Address:
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Telephone:
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+45 40683217 |
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Email:
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sots@rn.dk |
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Affiliation:
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Name:
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Lars Arendt-Nielsen, Dr.Sci.Med. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Center for Sensory-Motor Interaction (SMI), Department of Health Sciences and Technology, Aalborg University |
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Name:
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Ewa M Roos, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark |
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Name:
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Søren T Skou, PhD-student |
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Address:
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Telephone:
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Email:
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Affiliation:
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Orthopaedic Research Unit, Aarhus University Aalborg Hospital, Denmark |
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Name:
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Michael S Rathleff, PhD-student |
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Address:
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Telephone:
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Email:
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Affiliation:
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Orthopaedic Surgery Research Unit, AARHUS UNIVERSITY HOSPITAL - AALBORG HOSPITAL |
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Name:
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Mogens B Laursen, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Orthopaedic Surgery Research Unit, AARHUS UNIVERSITY HOSPITAL - AALBORG HOSPITAL |
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Name:
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Ole H Simonsen, Dr.Med. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Orthopaedic Surgery Research Unit, AARHUS UNIVERSITY HOSPITAL - AALBORG HOSPITAL |
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Name:
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Sten Rasmussen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Orthopaedic Surgery Research Unit, AARHUS UNIVERSITY HOSPITAL - AALBORG HOSPITAL |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Knee-OA detected by x-ray (Kellgren & Lawrence grade 2 or greater)
- Considered a candidate for TKR by the orthopedic surgeon.
- The participant is > 18 years of age.
- The participant can provide relevant and adequate, informed consent.
Exclusion Criteria:
- Mean VAS > 6
- Investigator considers that the mental condition of the participant does not allow
participation.
- The participant is considered to be unable to follow the intervention.
- Not present in the region during the study.
- The participant must not be pregnant or plan pregnancy during the study.
- Cannot read or understand Danish*. * Due to the cost of interpreters the participant
must be able to read and understand Danish.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Osteoarthritis of the Knee
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Intervention(s)
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Behavioral: Dietary counseling
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Behavioral: Patient education
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Drug: Burana
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Drug: Pantoprazol
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Drug: Paracetamol
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Other: Insoles
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Other: Neuromuscular training (NEMEX-TJR)
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Procedure: TKR
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Primary Outcome(s)
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KOOS4 (Knee injury and Osteoarthritis Outcome Score)
[Time Frame: Primary: 12months. Other: 3, 6 and 24 months.]
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Secondary Outcome(s)
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20-meter walk
[Time Frame: Primary: 12months. Other: 3, 6 and 24 months]
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EQ-5D
[Time Frame: Primary: 12months. Other: 3, 6 and 24 months]
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Isometric Muscle Strength
[Time Frame: Primary: 12months. Other: 3, 6 and 24 months]
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Pain
[Time Frame: Primary: 12months. Other: 3, 6 and 24 months]
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Self-efficacy
[Time Frame: Primary: 12months. Other: 3, 6 and 24 months]
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Timed Up & Go (TUG)
[Time Frame: Primary: 12months. Other: 3, 6 and 24 months]
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Visual Analog Scale (VAS)
[Time Frame: Primary: 12months. Other: 3, 6 and 24 months]
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Secondary ID(s)
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N-20110024
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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