Osteoarthritis of the Knee Clinical Trial
Official title:
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
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.
Knee osteoarthritis (OA) is the degenerative joint disease that most often requires treatment
and at the same time the one associated with the greatest social costs. In addition, the
disease has many personal costs and is greatly contributing to reduced functionality and
autonomy of older adults.
It is recommended both nationally and internationally that the treatment of knee OA should
include multiple treatment modalities. Clinical guidelines recommend that exercise, weight
loss and patient education is the first step in treatment and that insoles and
pharmacological treatment can be included as a supplement. If this non-surgical treatment is
ineffective surgical treatment, especially surgery with insertion of total knee replacement
(TKR), may be indicated. There are effects of both non-surgical treatment and TKR, but no
studies exist, which examine the effect of surgery with insertion of TKR in addition to the
recommended non-surgical treatment of knee OA.
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