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

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.

Conditions

• Osteoarthritis of the Knee

Interventions

OTHER

Neuromuscular training (NEMEX-TJR)

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

DRUG

Paracetamol

1 g x 4/day

DRUG

Burana

400 mg x 3/day for three weeks

DRUG

Pantoprazol

20mg x 1/day for three weeks

BEHAVIORAL

Dietary counseling

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.

BEHAVIORAL

Patient education

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.

PROCEDURE

TKR

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

OTHER

Insoles

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.

Sponsors & Collaborators

• The Danish Rheumatism Association

  collaborator OTHER

• Obel Family Foundation

  collaborator UNKNOWN

• Spar Nord Foundation

  collaborator UNKNOWN

• The Bevica Foundation

  collaborator UNKNOWN

• Aalborg University

  collaborator OTHER

• Association of Danish Physiotherapists

  collaborator OTHER

• Formthotics

  collaborator UNKNOWN

• Medical Specialist Heinrich Kopp's Grant

  collaborator UNKNOWN

• Danish Medical Association

  collaborator OTHER

• Northern Orthopaedic Division, Denmark

  lead OTHER

Principal Investigators

• Søren T Skou, PhD-student · Orthopaedic Research Unit, Aalborg University Hospital, Denmark

• Ewa M Roos, PhD · Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark

• Lars Arendt-Nielsen, Dr.Sci.Med. · Center for Sensory-Motor Interaction (SMI), Department of Health Sciences and Technology, Aalborg University

• Mogens B Laursen, PhD · Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

• Sten Rasmussen, MD · Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

• Michael S Rathleff, PhD-student · Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

• Ole H Simonsen, Dr.Med. · Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-09-30

Primary Completion

2015-03-31

Completion

2015-03-31

Countries

• Denmark

Study Locations