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)

Soren T Skou,Sten Rasmussen,Ole H Simonsen,Lars Arendt-Nielsen,Michael S Rathleff,Ewa M Roos,Mogens B Laursen

doi:10.1186/1471-2474-13-67

Abstract

BackgroundThere 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.Methods/DesignThe 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.DiscussionThis 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.Trial registrationClinicaltrials.gov reference: NCT01410409

Highlights

There is a lack of high quality evidence concerning the efficacy of total knee arthroplasty (TKA)
Patients considered eligible for total joint arthroplasty (TJA) on average report more pain and functional limitation than patients not eligible for TJA, the overlap is substantial and no cut-offs can be established [2]
On the basis of the existing evidence, clinical guidelines recommend a combination of patient education, exercise and weight loss as the first treatment option and that insoles and pharmacological treatment can be included as supplements [5,6,7]

Summary

Discussion

There is a lack of high quality evidence concerning the efficacy of TKA [6] and around 20 % of KOA patients experience little or no improvement in pain, disability and quality of life following the TKA [22]. There are several strengths of the design of this study This will be the first study assessing TKA in the treatment of KOA in a randomised, controlled design that can evaluate the additional effect of a TKA to the recommended non-surgical treatment. The purpose of this study is not to determine the effect of nonsurgical treatments compared with each other, but to evaluate the additive effect of TKA For this purpose, the design of the study can be considered optimal, since the MEDIC-treatment is a combination of recommended treatment modalities given to both groups [5,6]. A health economics assessment is included to evaluate the treatment in relation to cost-effectiveness and implementation

Background

Methods/Design

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28. Endres S