Structured Non-operative Treatment of Knee Osteoarthritis

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northern Orthopaedic Division, Denmark
• Collaborators: Association of Danish Physiotherapists; The Danish Rheumatism Association
• Treatments: Acetaminophen; Pantoprazole

Criteria

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.