Open Access Highly Accessed Study protocol

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 Skou125*, Ewa M Roos3, Mogens B Laursen1, Michael S Rathleff14, Lars Arendt-Nielsen2, Ole H Simonsen1 and Sten Rasmussen16

Author Affiliations

1 Orthopaedic Surgery Research Unit, Aalborg Hospital, Aarhus University Hospital, Aalborg, Denmark

2 Department of Health Science and Technology, Centre for Sensory-Motor Interaction, Aalborg University, Aalborg, Denmark

3 Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark

4 Graduate School of Health Sciences, Aarhus University, Aarhus, Denmark

5 Orthopaedic Surgery Research Unit, Aarhus University Hospital - Aalborg Hospital, Research and Innovation Center, 15 Soendre Skovvej, DK-9000, Aalborg, Denmark

6 School of Medicine and Health, Aalborg University, Aalborg, Denmark

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BMC Musculoskeletal Disorders 2012, 13:67  doi:10.1186/1471-2474-13-67

Published: 9 May 2012

Abstract

Background

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.

Methods/Design

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.

Discussion

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.

Trial registration

Clinicaltrials.gov reference: NCT01410409