Unloader One Study on Knee Osteoarthritis Hässleholm Sweden

Region Skane

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Device: Placebo brace; Device: Unloader One brace

Study type: Interventional

Funder types: Other

Identifiers

NCT03454776

Orthosestudy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups, including a placebo group

Unloader One brace

Active Comparator group

Description:

Patients receiving an active brace, Unloader One with active straps facilitating unloading of affected knee compartment

Treatment:

Device: Unloader One brace

Placebo brace

Placebo Comparator group

Description:

Patients receiving a dummy, lookalike or placebo brace without active straps that facilitate unloading of the affected knee compartment

Treatment:

Device: Placebo brace