Back to resultsUnloader One Study on Knee Osteoarthritis Hässleholm Sweden
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Unloader One brace
Placebo brace
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
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
Sites / Locations
- Orthopeadic Clinic Hässlehlm Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Unloader One brace
Placebo brace
Arm Description
Patients receiving an active brace, Unloader One with active straps facilitating unloading of affected knee compartment
Patients receiving a dummy, lookalike or placebo brace without active straps that facilitate unloading of the affected knee compartment
Outcomes
Primary Outcome Measures
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).
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)
Visual Analogue Scale (VAS)
VAS is presented as a range from 0 (no pain) to 100 (worst possible pain)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03454776
First Posted
January 29, 2018
Last Updated
March 26, 2019
Sponsor
Region Skane
Collaborators
Lund University
1. Study Identification
Unique Protocol Identification Number
NCT03454776
Brief Title
Unloader One Study on Knee Osteoarthritis Hässleholm Sweden
Official Title
The Effect of the Unloader One® Knee Brace on Symptoms in Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Skane
Collaborators
Lund University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups with same problem of osteoarthritis in knee
Masking
Investigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Unloader One brace
Arm Type
Active Comparator
Arm Description
Patients receiving an active brace, Unloader One with active straps facilitating unloading of affected knee compartment
Arm Title
Placebo brace
Arm Type
Placebo Comparator
Arm Description
Patients receiving a dummy, lookalike or placebo brace without active straps that facilitate unloading of the affected knee compartment
Intervention Type
Device
Intervention Name(s)
Unloader One brace
Intervention Description
A knee brace used to unload affected compartments in osteoarthritic knees
Intervention Type
Device
Intervention Name(s)
Placebo brace
Intervention Description
A knee brace that feels and looks like Unloader One but without active straps facilitating unloading of the knee
Primary Outcome Measure Information:
Title
Knee injury and Osteoarthritis Outcome Score (KOOS)
Description
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).
Time Frame
one year
Title
Knee Society Score (KSS)
Description
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)
Time Frame
one year
Title
Visual Analogue Scale (VAS)
Description
VAS is presented as a range from 0 (no pain) to 100 (worst possible pain)
Time Frame
one year
Title
EQ-5D
Description
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.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soren Toksvig-Larsen, Ass prof
Organizational Affiliation
Orthopeadic Clinic Hassleholm
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopeadic Clinic Hässlehlm Hospital
City
Hässleholm
State/Province
Skane
ZIP/Postal Code
28138
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
30243296
Citation
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.
Results Reference
derived
Learn more about this trial
Unloader One Study on Knee Osteoarthritis Hässleholm Sweden
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