Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement (MEDIC)

Northern Orthopaedic Division, Denmark

Status: Completed

Conditions: Osteoarthritis of the Knee

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01410409

N-20110024

Details and patient eligibility

About

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.

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 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.

Enrollment: 100 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 3 patient groups

MEDIC

Active Comparator group

Description:

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

Treatment:

Behavioral: Patient education

Drug: Burana

Other: Insoles

Behavioral: Dietary counseling

Drug: Paracetamol

Drug: Pantoprazol

Other: Neuromuscular training (NEMEX-TJR)

MEDIC + TKR

Active Comparator group

Description:

Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months after a total knee replacement.

Treatment:

Behavioral: Patient education

Drug: Burana

Other: Insoles

Behavioral: Dietary counseling

Drug: Paracetamol

Procedure: TKR

Drug: Pantoprazol

Other: Neuromuscular training (NEMEX-TJR)

Observational Cohort

Active Comparator group

Description:

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.

Treatment:

Behavioral: Patient education

Drug: Burana

Other: Insoles

Behavioral: Dietary counseling

Drug: Paracetamol

Procedure: TKR

Drug: Pantoprazol

Other: Neuromuscular training (NEMEX-TJR)