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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Unloader One brace; Device: Placebo brace

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Skane
    • Hässleholm, Skane, Sweden, 28138
      • Orthopeadic Clinic Hässlehlm Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Lund University
• Investigators: Principal Investigator: Soren Toksvig-Larsen, Ass prof, Orthopeadic Clinic Hassleholm

Publications and helpful links

General Publications

• Hjartarson HF, Toksvig-Larsen S. The clinical effect of an unloader brace on patients with osteoarthritis of the knee, a randomized placebo controlled trial with one year follow up. BMC Musculoskelet Disord. 2018 Sep 22;19(1):341. doi: 10.1186/s12891-018-2256-7.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: March 4, 2018
• First Posted (ACTUAL): March 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Orthosestudy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No