Unloader One Study on Knee Osteoarthritis Hässleholm Sweden

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Device: Placebo brace; Device: Unloader One brace

• Registration Number: NCT03454776
• Lead Sponsor: Region Skane

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.

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-03
• Study Completion: 2014-10
• Study First Submitted: 2018-01-29
• Study First Submitted QC: 2018-03-04
• Study First Posted: 2018-03-06
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo brace	Placebo brace	Patients receiving a dummy, lookalike or placebo brace without active straps that facilitate unloading of the affected knee compartment
Unloader One brace	Unloader One brace	Patients receiving an active brace, Unloader One with active straps facilitating unloading of affected knee compartment

Primary Outcome Measures

Name	Time	Method
Knee Society Score (KSS)	one year	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)
Visual Analogue Scale (VAS)	one year	VAS is presented as a range from 0 (no pain) to 100 (worst possible pain)
Knee injury and Osteoarthritis Outcome Score (KOOS)	one year	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).
EQ-5D	one year	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.

Trial Locations

Locations (1)

Orthopeadic Clinic Hässlehlm Hospital; 🇸🇪 Hässleholm, Skane, Sweden