Clinical trial NCT01410409
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis, Knee Treatment Outcome Time Factors Arthroplasty, Replacement Rehabilitation Combined Modality Therapy Middle Aged Aged Aged, 80 and over Male Female Humans Analysis of Variance
Sponsor: Northern Orthopaedic Division, Denmark
Start date: 2011-09-01; Completion date: 2015-03-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:
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.

Arms: arm 1: Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months. arm 2: Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months after a total knee replacement. arm 3: If the patient can be included, but doesn't want to participate in the randomization, the patient is offered to enter into a prospective observational cohort with the same endpoints and the same follow-up as in the randomized study. The participant can then, in consultation with his/her physician, choose whether they would like MEDIC-treatment or TKR in combination with MEDIC-treatment.
Interventions: intervention 1: Neuromuscular training (NEMEX-TJR) intervention 2: Paracetamol intervention 3: Burana intervention 4: Pantoprazol intervention 5: Dietary counseling intervention 6: Patient education intervention 7: TKR intervention 8: Insoles
Intervention descriptions: intervention 1: 60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR. intervention 2: 1 g x 4/day intervention 3: 400 mg x 3/day for three weeks intervention 4: 20mg x 1/day for three weeks intervention 5: 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. intervention 6: 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. intervention 7: Surgical treatment with insertion of total knee replacement following standard procedures. intervention 8: 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.

Protocol documents: