Unloader One Study on Knee Osteoarthritis Hässleholm Sweden

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03454776
• Other study ID #: Orthosestudy
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: October 2014

Study information

• Verified date: March 2019
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Unloader One brace
A knee brace used to unload affected compartments in osteoarthritic knees
• Placebo brace
A knee brace that feels and looks like Unloader One but without active straps facilitating unloading of the knee

Locations

Country	Name	City	State
Sweden	Orthopeadic Clinic Hässlehlm Hospital	Hässleholm	Skane

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Visual Analogue Scale (VAS)	VAS is presented as a range from 0 (no pain) to 100 (worst possible pain)	one year
Primary	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