Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement

Northern Orthopaedic Division, Denmark100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Interventions

Neuromuscular training (NEMEX-TJR)OTHER

60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.

ParacetamolDRUG

1 g x 4/day

BuranaDRUG

400 mg x 3/day for three weeks

PantoprazolDRUG

20mg x 1/day for three weeks

Dietary counselingBEHAVIORAL

For participants with a BMI equal to or \>25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet and plans the number of visits according to the individual participant needs.

Patient educationBEHAVIORAL

The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA. This aspect of the intervention is based on principles from The Chronic Disease Self-Management Program, "Lær at leve med kronisk sygdom (Learn to live with chronic illness)" by The National Board of Health, Denmark and "Artrosskolan Spenshult" in Sweden.

TKRPROCEDURE

Surgical treatment with insertion of total knee replacement following standard procedures.

InsolesOTHER

The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral). The participants will be advised to use the insoles in all shoes.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Knee-OA detected by x-ray (Kellgren \& Lawrence grade 2 or greater) * Considered a candidate for TKR by the orthopedic surgeon. * The participant is \> 18 years of age. * The participant can provide relevant and adequate, informed consent. Exclusion Criteria: * Bilateral simultaneous TKR * Revision of prior TKR, unicompartmental knee arthroplasty or high tibial osteotomy * Rheumatoid arthritis * Mean VAS \> 60mm on a 0-100mm scale * Investigator considers that the mental condition of the participant does not allow participation. * The participant must not be pregnant or plan pregnancy during the study. * Inability to comply with the protocol;. * Inadequacy in written and spoken Danish.

Outcomes

Primary Outcomes

Change in KOOS4 From Baseline (Knee Injury and Osteoarthritis Outcome Score)

The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best). Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. We expect the change to be normally distributed and analysis will be made using a mixed model ANOVA with subject being a random factor and visit (baseline, 3, 6 and 12 months), treatment arm (TKA + MEDIC, MEDIC) and site (Frederikshavn, Farsoe) being fixed factors. Baseline KOOS4 will be a covariate. Furthermore interactions between the fixed factors will be included in the model. P-values and 95% CI will be presented to assess superiority.