Total knee replacement plus physical and medical therapy or treatment with physical and medical therapy alone: a randomised controlled trial in patients with knee osteoarthritis (the MEDIC-study).
ABSTRACT There is a lack of high quality evidence concerning the efficacy of total knee arthroplasty (TKA). According to international evidence-based guidelines, treatment of knee osteoarthritis (KOA) should include patient education, exercise and weight loss. Insoles and pharmacological treatment can be included as supplementary treatments. If the combination of these non-surgical treatment modalities is ineffective, TKA may be indicated. The purpose of this randomised controlled trial is to examine whether TKA provides further improvement in pain, function and quality of life in addition to optimised non-surgical treatment in patients with KOA defined as definite radiographic OA and up to moderate pain.
The study will be conducted in The North Denmark Region. 100 participants with radiographic KOA (K-L grade ≥2) and mean pain during the previous week of ≤ 60 mm (0-100, best to worst scale) who are considered eligible for TKA by an orthopaedic surgeon will be included. The treatment will consist of 12 weeks of optimised non-surgical treatment consisting of patient education, exercise, diet, insoles, analgesics and/or NSAIDs. Patients will be randomised to either receiving or not receiving a TKA in addition to the optimised non-surgical treatment. The primary outcome will be the change from baseline to 12 months on the Knee Injury and Osteoarthritis Outcome Score (KOOS)(4) defined as the average score for the subscale scores for pain, symptoms, activities of daily living, and quality of life. Secondary outcomes include the five individual KOOS subscale scores, EQ-5D, pain on a 100 mm Visual Analogue Scale, self-efficacy, pain pressure thresholds, and isometric knee flexion and knee extension strength.
This is the first randomised controlled trial to investigate the efficacy of TKA as an adjunct treatment to optimised non-surgical treatment in patients with KOA. The results will significantly contribute to evidence-based recommendations for the treatment of patients with KOA.
Clinicaltrials.gov reference: NCT01410409.
Article: Patient education interventions in osteoarthritis and rheumatoid arthritis: a meta-analytic comparison with nonsteroidal antiinflammatory drug treatment.[show abstract] [hide abstract]
ABSTRACT: To compare the effects of education interventions and nonsteroidal antiinflammatory drug (NSAID) treatment on pain and functional disability in patients with osteoarthritis (OA), and on pain, functional disability, and tender joint counts in patients with rheumatoid arthritis (RA). Two meta-analyses were performed: one of controlled trials of patient education interventions and one of placebo-controlled trials of NSAID treatments. Nineteen patient education trials comprised of 32 treatment arms and 28 NSAID trials comprised of 46 treatment arms were included. The weighted average effect size for pain was 0.17 in the education trials and 0.66 in the NSAID trials. The average effect size for functional disability was 0.03 in the education trials and 0.34 in the NSAID trials; effects of education were much larger in RA studies than in OA studies. In RA studies, the average effect size for the tender joint count was 0.34 in the education trials and 0.43 in the NSAID trials. Because most patients in the education trials were being treated with medications, the effect sizes of these trials represent the additional, or marginal, effects of patient education interventions beyond those achieved by medication. Based on this meta-analysis, patient education interventions provide additional benefits that are 20-30% as great as the effects of NSAID treatment for pain relief in OA and RA, 40% as great as NSAID treatment for improvement in functional ability in RA, and 60-80% as great as NSAID treatment in reduction in tender joint counts in RA.Arthritis care and research: the official journal of the Arthritis Health Professions Association 09/1996; 9(4):292-301.