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