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Completed

NCT Number: NCT03454776

Unloader One Study on Knee Osteoarthritis Hässleholm Sweden

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopeadic Clinic Hässlehlm Hospital

Hässleholm, Skåne County, 28138, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unloader One brace

Device

A knee brace used to unload affected compartments in osteoarthritic knees

Placebo brace

Device

A knee brace that feels and looks like Unloader One but without active straps facilitating unloading of the knee

Primary outcomes

  1. Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 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).

  2. Knee Society Score (KSS)

    Time frame: 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)

  3. Visual Analogue Scale (VAS)

    Time frame: one year

    VAS is presented as a range from 0 (no pain) to 100 (worst possible pain)

  4. EQ-5D

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Lund University

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Mar 6, 2018
Registry last updated
Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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