Knee OsteoarthritisORFEVRENCT01884883
Evaluation of a Distraction-rotation Knee Unloader Brace in Patients With Medial Knee Osteoarthritis.
A study testing PROTEOR Internal unicompartmental knee brace in people with Knee Osteoarthritis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The aim of this study is to confirm the biomechanical effects and evaluate functional benefits of a new knee brace combining valgus inducing effect on medial compartment and leg external rotation during the stance phase in patients with symptomatic medial knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- PROTEOR Internal unicompartmental knee brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- May 2010to Dec 2011
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient understanding simple order and able to give written consent.
- Man or woman with age between 40 et 75 years
- Unilateral medial symptomatic knee osteoarthritis, defined using the American College of Rheumatology classification
- Radiologic grade II, III ou IV (Kellgren et Lawrence (KL) classification)
- Medial knee compartment (Medial K\&L g rade higher than lateral K\&L grade
- Knee pain > 40/100 on visual analog scale and <30/100 for the other
- No change in medical treatment for at least 3 months.
- Latest radiographic image < 12 months before inclusion
Who cannot join
- Patient without healthcare insurance.
- Inflammatory knee arthritis,
- Indication of knee surgery
- Pregnancy, breastfeeding
- Associate neurologic or orthopaedic affection that interferes with gait analysis
- Rapidly destructive arthritis.
- Alzheimer's disease, Parkinson's disease, motor neuronal disorders
- Patient under guardianship or tutelage
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to confirm the biomechanical effects and evaluate functional benefits of a new knee brace combining valgus inducing effect on medial compartment and leg external rotation during the stance phase in patients with symptomatic medial knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- PROTEOR Internal unicompartmental knee 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.
PROTEOR Internal unicompartmental knee braceDevice
Also called trademark : " PROTEOR " : code name 2H-200
| Study group | Role | What they receive |
|---|---|---|
| Internal unicompartmental knee brace | Other | Not described Receives: Device: PROTEOR Internal unicompartmental knee brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score on visual analogic scale
Pain was self-evaluated by patient on visual analogic scale (VAS: 0-100, 0 = no pain at all; 100 = worst pain appendix 1). Such pain is widely used and validated in the literature for the evaluation of knee osteoarthritis treatment outcome.
Measured: Baseline
Pain score on visual analogic scale
Pain was self-evaluated by patient on visual analogic scale (VAS: 0-100, 0 = no pain at all; 100 = worst pain appendix 1). Such pain is widely used and validated in the literature for the evaluation of knee osteoarthritis treatment outcome.
Measured: Baseline + 5 weeks
Secondary outcomes (2)
Evaluation of the functional capacities: KOOS questionnaire.
Measured: baseline
Evaluation of the functional capacities: KOOS questionnaire.
Measured: baseline + 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startMay 2010
- Primary completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Francis Maillefert, Principal investigator, CHU Dijon - Department of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884883
- Sponsor's protocol ID
- MAILLEFERT 2010
- Acronym
- ORFEVRE
- Status last verified
- Jun 2013
- First submitted
- 18 Jun 2013
- Last updated
- 24 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Distraction-rotation Knee Unloader Brace in Patients With Medial Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT01884883
- Acronym / sponsor ID
- ORFEVRE / MAILLEFERT 2010
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2011 (actual)
- First posted
- 24 Jun 2013 (estimated)
- 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 aim of this study is to confirm the biomechanical effects and evaluate functional benefits of a new knee brace combining valgus inducing effect on medial compartment and leg external rotation during the stance phase in patients with symptomatic medial knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internal unicompartmental knee brace | Other | Device: PROTEOR Internal unicompartmental knee brace |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient understanding simple order and able to give written consent.
- Man or woman with age between 40 et 75 years
- Unilateral medial symptomatic knee osteoarthritis, defined using the American College of Rheumatology classification
- Radiologic grade II, III ou IV (Kellgren et Lawrence (KL) classification)
- Medial knee compartment (Medial K\&L g rade higher than lateral K\&L grade
Key exclusion criteria (8 listed)
- Patient without healthcare insurance.
- Inflammatory knee arthritis,
- Indication of knee surgery
- Pregnancy, breastfeeding
- Associate neurologic or orthopaedic affection that interferes with gait analysis
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 |
|---|---|---|
| PROTEOR Internal unicompartmental knee braceAlso: trademark : " PROTEOR " : code name 2H-200 | Device | Internal unicompartmental knee brace |
Primary outcome
Pain score on visual analogic scale
Time frame: Baseline
Pain was self-evaluated by patient on visual analogic scale (VAS: 0-100, 0 = no pain at all; 100 = worst pain appendix 1). Such pain is widely used and validated in the literature for the evaluation of knee osteoarthritis treatment outcome.
Pain score on visual analogic scale
Time frame: Baseline + 5 weeks
Pain was self-evaluated by patient on visual analogic scale (VAS: 0-100, 0 = no pain at all; 100 = worst pain appendix 1). Such pain is widely used and validated in the literature for the evaluation of knee osteoarthritis treatment outcome.
2 secondary outcomes
Evaluation of the functional capacities: KOOS questionnaire.
Time frame: baseline
Evaluation of the functional capacities: KOOS questionnaire.
Time frame: baseline + 5 weeks
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 24 Jun 2013.
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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.
Jean-Francis Maillefert principal investigator
CHU Dijon - Department of Rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROTEOR Internal unicompartmental knee brace in people with Knee Osteoarthritis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 8 inclusion and 8 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 24 Jun 2013. 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 France. 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. 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?
Pain score on visual analogic scale (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2013.