Unloader One Study on Knee Osteoarthritis Hässleholm Sweden

The Effect of the Unloader One® Knee Brace on Symptoms in Patients With Knee Osteoarthritis

The purpose of this study is to assess the effect of the Unloader one brace on the clinical symptoms of patients with knee osteoarthritis (OA) by comparing a functioning brace with a dummy.

The purpose of this study is to assess the effect of the Unloader one brace on the clinical symptoms of patients with knee OA by comparing a functioning brace with a dummy. The dummy will be manufactured by Össur and has the same look as the real brace, but lacks the fundamental tightening effect of the straps of the real brace (an insert of elastic bands assures this), thereby nullifying its unloading capabilities. In a recent trial by Dr. Ingvarsson, the brace seemed to lessen the pain from knee OA, but no randomised, controlled studies have been conducted. This is mandatory if the effect of the brace and its use as an accepted treatment for knee OA is to be advocated for general use.

Inclusion Criteria:

Patients fulfilling all criteria listed below will be considered to eligible for participation in the study:

• Patient, men and women, age 30 to 70 with knee OA not scheduled for surgery who understand the given information and are willing to participate in this study.
• Signed informed patient consent
• BMI < 35
• Knee pain for more than 3 month
• Patients with Knee OA Ahlbäck grade 1 and 2 and/or Kellgren-Lawrence 1 and 2
• Patient with arthroscopic OA but do not have regular grade 1 OA

Exclusion Criteria:

Patient presenting with any of the following will not be included in the study:

• prior major surgery to the same knee
• patients with a history of stroke or neurological or psychiatric decease that potentially could affect the perception of pain
• obesity (BMI > 35)
• active or suspected infection
• patients taking opioids or steroids
• patients suffering from rheumatoid arthritis or have a immunological depression
• patients with other severe medical problems that could affect the perioperative course
• the patient had an intraarticular steroid injection in the actual knee during the last 3 months
• Patient participating in a clinical trial