Unloader One Study on Knee Osteoarthritis Hässleholm Sweden

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Device: Unloader One brace
* Device: Placebo brace


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups with same problem of osteoarthritis in knee
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Unloader One brace<br>Patients receiving an active brace, Unloader One with active straps facilitating unloading of affected knee compartment | Device: Unloader One brace<br>* A knee brace used to unload affected compartments in osteoarthritic knees<br>|
| Placebo Comparator: Placebo brace<br>Patients receiving a dummy, lookalike or placebo brace without active straps that facilitate unloading of the affected knee compartment | Device: Placebo brace<br>* A knee brace that feels and looks like Unloader One but without active straps facilitating unloading of the knee<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee injury and Osteoarthritis Outcome Score (KOOS) | Standardized questionaire for knee problems, divided into 5 subscores of pain, symptoms, activity of daily living, sports/recreation and quality of life. Each subscore is presented from 0 (worst) to 100 (best). | one year | 
| Knee Society Score (KSS) | Standardized outcome measure for knee problems presented in two subgroups of KSS Score and KSS Function, presented on a range from 0 (worst) to 100 (best) | one year | 
| Visual Analogue Scale (VAS) | VAS is presented as a range from 0 (no pain) to 100 (worst possible pain) | one year | 
| EQ-5D | EQ-5D comprises two distinct self-report elements, providing three principal approaches to analysis(1) the EQ-5D profile: the patients' self reported health on the dimensions/levels of the descriptive system (2) the EQ-VAS: the patients' own global rating of their overall health, on a scale from 0 (worst possible health) to100 (best possible health)• Both types of data can be the focus of analysis, plus(3) Profiles can be summarized using 'value sets' (EQ-5DIndex) which reflect the preferences of the general public. | one year |