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

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Northern Orthopaedic Division, Denmark
• Collaborators: Aalborg University; Association of Danish Physiotherapists; Danish Medical Association; Formthotics; Medical Specialist Heinrich Kopp's Grant; Obel Family Foundation; Spar Nord Foundation; The Bevica Foundation; The Danish Rheumatism Association
• Treatments: Acetaminophen; Pantoprazole

Criteria

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.