Structured Non-operative Treatment of Knee Osteoarthritis

Northern Orthopaedic Division, Denmark

Status: Completed

Conditions: Osteoarthritis of the Knee

Treatments: Behavioral: Information; Drug: Paracetamol; Other: Neuromuscular training (NEMEX-TJR); Behavioral: Dietary counseling; Other: Insoles; Behavioral: Patient education; Drug: Burana; Drug: Pantoprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01535001

N-20110085

Details and patient eligibility

About

The purpose of this study is to test whether an algorithm for systematic non-surgical treatment consisting of corrective insoles, neuromuscular training, weight loss, patient education and pharmacological treatment with paracetamol, non steroidal anti inflammatory drugs (NSAIDs) and Pantoprazole provides further improvement in pain, function and quality of life than standard non-surgical treatment (information on the disease and how to treat it) in patients with knee osteoarthritis.

The H1-hypothesis is that the treatment algorithm results in a greater increase in quality of life and functional capacity and greater reduction in pain than standard treatment 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.

Full 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 osteoarthritis 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.

However if the patient is not a candidate for total knee replacement, the patient most often receives only information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse. This postponement of treatment can lead to a worsening of pain and function and a worse outcome after treatment. Therefore, the current treatment strategy for the patient group is problematic.

The current practice may be due to the lack of studies with high level of evidence that have examined the optimal non-operative treatment approach and compared it with the current standard treatment for this group of patients.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Knee-OA detected by x-ray (Kellgren & Lawrence grade 1 or greater)
• KOOS4 of ≤ 75
• Considered not to be a candidate for Total Knee Replacement (TKR) by the orthopedic surgeon.
• The participant is > 18 years of age.
• The participant can provide relevant and adequate, informed consent.

Exclusion criteria

• Prior TKA ipsilateral
• Rheumatoid arthritis
• Mean VAS > 60mm the last week on a 0-100mm scale
• Possible pregnancy or planning pregnancy;
• Inability to comply with the protocol;
• Inadequacy in written and spoken Danish.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

MEDIC

Active Comparator group

Description:

Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months.

Treatment:

Drug: Pantoprazole

Drug: Burana

Other: Insoles

Behavioral: Patient education

Behavioral: Dietary counseling

Other: Neuromuscular training (NEMEX-TJR)

Drug: Paracetamol

Standard treatment

Active Comparator group

Description:

Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.

Treatment:

Behavioral: Information