Osteoarthritis, KneeNCT03454776
Unloader One Study on Knee Osteoarthritis Hässleholm Sweden
A study testing Unloader One brace in people with Osteoarthritis, Knee, run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Unloader One brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
Sweden1 site
Orthopeadic Clinic Hässlehlm Hospital
Hässleholm, Skåne County, 28138
About this study
Official title: The Effect of the Unloader One® Knee Brace on Symptoms in Patients With Knee Osteoarthritis
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Unloader One brace, Placebo brace
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unloader One braceDevice
A knee brace used to unload affected compartments in osteoarthritic knees
Placebo braceDevice
A knee brace that feels and looks like Unloader One but without active straps facilitating unloading of the knee
| Study group | Role | What they receive |
|---|---|---|
| Unloader One brace | Active comparator | Patients receiving an active brace, Unloader One with active straps facilitating unloading of affected knee compartment Receives: Device: Unloader One brace |
| Placebo brace | Placebo comparator | Patients receiving a dummy, lookalike or placebo brace without active straps that facilitate unloading of the affected knee compartment Receives: Device: Placebo brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one year
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)
Measured: one year
Visual Analogue Scale (VAS)
VAS is presented as a range from 0 (no pain) to 100 (worst possible pain)
Measured: one year
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study startApr 2012
- Primary completionMar 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups with same problem of osteoarthritis in knee
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Principal investigator, Sören Toksvig-Larsen, Region Skane
- Investigators
- Soren Toksvig-Larsen, Ass prof, Principal investigator, Orthopeadic Clinic Hassleholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454776
- Sponsor's protocol ID
- Orthosestudy
- Status last verified
- Mar 2019
- First submitted
- 29 Jan 2018
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
Publications
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.
PubMed 30243296
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Unloader One® Knee Brace on Symptoms in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03454776
- Acronym / sponsor ID
- Orthosestudy
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- Apr 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Two groups with same problem of osteoarthritis in knee
| Arm | Type | Receives |
|---|---|---|
| Unloader One brace | Active comparator | Device: Unloader One bracePatients receiving an active brace, Unloader One with active straps facilitating unloading of affected knee compartment |
| Placebo brace | Placebo comparator | Device: Placebo bracePatients receiving a dummy, lookalike or placebo brace without active straps that facilitate unloading of the affected knee compartment |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unloader One braceA knee brace used to unload affected compartments in osteoarthritic knees | Device | Unloader One brace |
| Placebo braceA knee brace that feels and looks like Unloader One but without active straps facilitating unloading of the knee | Device | Placebo brace |
Primary outcome
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).
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)
Visual Analogue Scale (VAS)
Time frame: one year
VAS is presented as a range from 0 (no pain) to 100 (worst possible pain)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Derived from this study: PubMed 30243296Hjartarson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soren Toksvig-Larsen, Ass prof principal investigator
Orthopeadic Clinic Hassleholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unloader One brace in people with Osteoarthritis, Knee, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee injury and Osteoarthritis Outcome Score (KOOS) (time frame: one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03454776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.