Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement
Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to test whether surgical insertion of total knee replacement
provides further improvement in quality of life, pain and function in addition to an
algorithm for systematic non-surgical treatment consisting of corrective insoles,
neuromuscular training, weight loss, patient education and pharmacological treatment with
paracetamol, NSAIDs and Pantoprazol in patients with knee OA, collectively called the
MEDIC-treatment(Medicine Exercise Diet Insoles Cognitive).
The H1-hypothesis is that surgery with insertion of TKR in addition to the MEDIC-treatment
results in a greater increase in quality of life and functional capacity and greater
reduction in pain than the MEDIC- treatment alone at the primary endpoint, which is follow-up
12months after the start of the treatment.
See statistical analysis plan available under "Links" for further description of the study.
Phase:
N/A
Details
Lead Sponsor:
Northern Orthopaedic Division, Denmark
Collaborators:
Aalborg University Association of Danish Physiotherapists Danish Medical Association Formthotics Medical Specialist Heinrich Kopp's Grant Obel Family Foundation Spar Nord Foundation The Bevica Foundation The Danish Rheumatism Association