NCT03454776

Unloader One Study on Knee Osteoarthritis Hässleholm Sweden

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	Unloader One brace	A knee brace used to unload affected compartments in osteoarthritic knees
DEVICE	Placebo brace	A knee brace that feels and looks like Unloader One but without active straps facilitating unloading of the knee

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-03-01
• Completion: 2014-10-01
• First posted: 2018-03-06
• Last updated: 2019-03-27

Locations

1 site across 1 country: Sweden