Status:

COMPLETED

Unloader One Study on Knee Osteoarthritis Hässleholm Sweden

Lead Sponsor:

Region Skane

Collaborating Sponsors:

Lund University

Conditions:

Osteoarthritis, Knee

Eligibility:

All Genders

30-70 years

Phase:

NA

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 manufactu...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2014

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT03454776

Start Date

April 1 2012

End Date

October 1 2014

Last Update

March 27 2019

Active Locations (1)

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1

Orthopeadic Clinic Hässlehlm Hospital

Hässleholm, Skåne County, Sweden, 28138