Osteoarthritis, KneeUNIBRACENCT05905809
Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis
A study testing UniRelieverTM offloading brace (THUASNE) and Unloader One® X brace (Össur) in people with Osteoarthritis, Knee, run by Thuasne at 1 site in Germany.
Trial summary
The objective of this study is to assess the efficacy and performance of a new semi-rigid offloading brace in the management of knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- UniRelieverTM offloading brace (THUASNE) and Unloader One® X brace (Össur)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 7 Jun 2023to 20 Sep 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Medial femorotibial knee osteoarthritis grade 2, 3 or 4 according to the Kellgren Lawrence system
- Visual Analog Scale pain ≥ 40/100 in the last 48 hours
- Signed informed consent prior to any study-mandated procedure.
- Affiliated to the General regime of the Social Security or covered by a similar health insurance system
Who cannot join
- Inability to walk or dependance on a wheelchair or use of crutches.
- Diseases that do not allow participation in the study for a period of six weeks.
- Concomitant ipsilateral patellofemoral osteoarthritis associated with a more severe pain than the one for medial OA.
- Ipsilateral osteoarthritis of the hip associated with a more severe pain than the one for medial OA.
- A body mass index over 35.
- Successful Cortisone injection within the last four weeks before the start of the study.
Show all 9Show fewer
- Participation to any other clinical study which has an impact on the different endpoints.
- Vulnerable patient, adults being the object of a legal protective measure or enable to express their consent.
- Inability to communicate in German.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Trauma Orthopedic Surgery Practice Center
Aachen, Friedrich-Wilhelm-Platz 5, 52062
About this study
Official title: Controlled, Randomized, Open Label Study to Assess the Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis
The objective of this study is to assess the efficacy and performance of a new semi-rigid offloading brace in the management of knee osteoarthritis.
Read the detailed description
Osteoarthritis (OA) is one of the leading causes of physical disability in the world, affecting a growing portion of the elderly, indeed, it is estimated that 85% of all people over age 60 have some degree of OA.
A survey of 2000 French general practitioners indicated that 10% usually prescribe knee orthoses for patients with knee OA. With the increasing importance of non-pharmacological treatment in recommendations for OA, orthoses will increase in use.
The use of an offloading knee brace that encompasses the knee has proven to be a safe, cost-efficient treatment option for reducing pain and improving function. It can even delay the need for surgery.
The aim of this study is to perform a randomized, prospective, interventional, 3-arm parallel group study to look at the difference in outcome in knee osteoarthritic patient with the use of the new semi-rigid offloading brace versus knee brace comparator versus without orthosis.
- Conditions
- Osteoarthritis, Knee
- Being tested
- UniRelieverTM offloading brace (THUASNE), Unloader One® X brace (Össur)
- Keywords
- Osteoarthritis, Knee Brace, Knee functional capacity, Pain, Compliance
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UniRelieverTM offloading brace (THUASNE)Device
The patient will be instructed to wear the brace during walking and physical exercise. The investigator will explain to the patient how to adjust it
Unloader One® X brace (Össur)Device
The patient will be instructed to wear the brace during walking and physical exercise. The investigator will explain to the patient how to adjust it
| Study group | Role | What they receive |
|---|---|---|
| Group I with UniRelieverTM offloading brace | Experimental | Patients wearing the UniRelieverTM offloading brace (THUASNE):
For intervention group I, in addition to the usual care described above for the control group, patients will wear the studied UniRelieverTM offloading brace. Receives: Device: UniRelieverTM offloading brace (THUASNE) |
| Group II with Unloader One® X brace | Experimental | Patients wearing the Unloader One® X brace (Össur):
For intervention group II, in addition to the usual care described above for the control group, patients will wear the Unloader One® X brace by Össur Receives: Device: Unloader One® X brace (Össur) |
| Group III without orthosis | No intervention | Patients wearing no orthosis: In the control group, usual care is defined by: * buffer heel and/or * insoles and/or * outer edge raisin and/or * walking stick and/or * physiotherapy and/ or * analgesics oral and local depending on the patient's needs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-free walking distance
The evolution of pain-free walking distance evaluated by reporting the distance that the patient can walk without pain.
Measured: 6 weeks
Secondary outcomes (10)
Knee functional capacity
The evolution of knee functional capacity is evaluated by the Lequesne index completed by the patient at inclusion and six weeks of follow-up (minimum index score 0: None handicap, maximum index score 24: Handicap extremely severe)
Measured: 6 weeks
Pain on loading
The evolution of pain on loading is measured via a numerical rating scale (NRS) after a thirty-minute walk at inclusion and six weeks of follow-up: 0 corresponds to no pain (better outcome) and 10 to maximum pain (worst outcome)
Measured: 6 weeks
Pain at rest
The evolution of pain at rest is measured via a numerical rating scale (NRS) at inclusion and six weeks of follow-up: 0 corresponds to no pain (better outcome) and 10 to maximum pain (worst outcome)
Measured: 6 weeks
Analgesic consumption
The use of analgesics is collected all along the study via a patient's diary completed by the patient every day and via the physician during the inclusion and the six weeks follow-up visit .
Measured: 6 weeks
Subjective range of movement
The subjective knee range of movement is assessed qualitatively by having patients rate it as follow:
- 'clearly improved',
- 'improved',
- 'unchanged',
- 'deteriorated'
- 'clearly deteriorated'.
Measured: 6 weeks
Objective range of movement
The objective improvement of knee range of movement is assessed quantitatively by a goniometer (range of movement measure expressed in degrees)
Measured: 6 weeks
Assessment of Patient's Global Impression of Change (PGI-C)
Patient's opinion on Global Impression of Change about his/her general condition by using the PGIC questionnaire completed at the six weeks follow-up visit by the patient. The scale has 7 levels from "no change or condition has got worsed"(worse outcome) to "a great deal better, and a considerable improvement that has made all the difference (better outcome)". Intermediate levels are: "almost the same, hardly any change at all"; "a little better, but no noticeable change", "somewhat better, but the change has not made any real difference"; "moderately better, and a slight but noticeable change"; "better, and a definite improvement that has made a real and worthwhile difference
Measured: 6 weeks
Assessment of compliance
The evaluation of compliance with devices during the duration of the study is reported by the investigator according to the patient's diary completed by the patient each day.
Measured: 6 weeks
Assessment of patient's satisfaction
The evaluation of patient satisfaction with devices is assessed via a self-questionnaire at the end of the study
Measured: 6 weeks
Assessment of safety (AE and SAEs)
The safety of the devices is evaluated by the description of Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring during the study and collected by the patient via the patient's diary and the investigator during follow-up visits:
- number,
- type,
- frequency,
- intensity,
- relationship with the study device
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start7 Jun 2023
- Primary completion20 Sep 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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
- An interventional, prospective, monocentric, randomized, open and controlled study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thuasne
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MED-RAS GmbH
- Responsible party
- Sponsor
- Investigators
- Michael Benning, MD, Principal investigator, Trauma Orthopedic Surgery Practice Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905809
- Sponsor's protocol ID
- EC43
- Acronym
- UNIBRACE
- Status last verified
- Apr 2024
- First submitted
- 26 May 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beaudreuil J. Orthoses for osteoarthritis: A narrative review. Ann Phys Rehabil Med. 2017 Apr;60(2):102-106. doi: 10.1016/j.rehab.2016.10.005. Epub 2016 Dec 6.
PubMed 27939833Grazina R, Andrade R, Bastos R, Costa D, Pereira R, Marinhas J, Maestro A, Espregueira-Mendes J. Clinical Management in Early OA. Adv Exp Med Biol. 2018;1059:111-135. doi: 10.1007/978-3-319-76735-2_5.
PubMed 29736571Hjartarson 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 30243296Maleki M, Arazpour M, Joghtaei M, Hutchins SW, Aboutorabi A, Pouyan A. The effect of knee orthoses on gait parameters in medial knee compartment osteoarthritis: A literature review. Prosthet Orthot Int. 2016 Apr;40(2):193-201. doi: 10.1177/0309364614547411. Epub 2014 Aug 26.
PubMed 25160784Parween R, Shriram D, Mohan RE, Lee YHD, Subburaj K. Methods for evaluating effects of unloader knee braces on joint health: a review. Biomed Eng Lett. 2019 Jan 23;9(2):153-168. doi: 10.1007/s13534-019-00094-z. eCollection 2019 May.
PubMed 31168421Petersen W, Ellermann A, Henning J, Nehrer S, Rembitzki IV, Fritz J, Becher C, Albasini A, Zinser W, Laute V, Ruhnau K, Stinus H, Liebau C. Non-operative treatment of unicompartmental osteoarthritis of the knee: a prospective randomized trial with two different braces-ankle-foot orthosis versus knee unloader brace. Arch Orthop Trauma Surg. 2019 Feb;139(2):155-166. doi: 10.1007/s00402-018-3040-8. Epub 2018 Sep 25.
PubMed 30255369Pham T, van der Heijde D, Altman RD, Anderson JJ, Bellamy N, Hochberg M, Simon L, Strand V, Woodworth T, Dougados M. OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage. 2004 May;12(5):389-99. doi: 10.1016/j.joca.2004.02.001.
PubMed 15094138Raja K, Dewan N. Efficacy of knee braces and foot orthoses in conservative management of knee osteoarthritis: a systematic review. Am J Phys Med Rehabil. 2011 Mar;90(3):247-62. doi: 10.1097/PHM.0b013e318206386b.
PubMed 21273902Benning M, Villet S, Marques A, Hilgers RD. The effectiveness of the UniReliever offloading knee brace for treating medial knee osteoarthritis: A randomized clinical trial. Prosthet Orthot Int. 2026 Aug 1;50(4):426-433. doi: 10.1097/PXR.0000000000000503. Epub 2025 Dec 3.
PubMed 41331771
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled, Randomized, Open Label Study to Assess the Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05905809
- Acronym / sponsor ID
- UNIBRACE / EC43
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee Brace, Knee functional capacity, Pain, Compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ThuasneIndustry (pharma, biotech, devices)
- Collaborators
- MED-RAS GmbH
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 15 Jun 2023 (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 objective of this study is to assess the efficacy and performance of a new semi-rigid offloading brace in the management of knee osteoarthritis.
Detailed description
Osteoarthritis (OA) is one of the leading causes of physical disability in the world, affecting a growing portion of the elderly, indeed, it is estimated that 85% of all people over age 60 have some degree of OA.
A survey of 2000 French general practitioners indicated that 10% usually prescribe knee orthoses for patients with knee OA. With the increasing importance of non-pharmacological treatment in recommendations for OA, orthoses will increase in use.
The use of an offloading knee brace that encompasses the knee has proven to be a safe, cost-efficient treatment option for reducing pain and improving function. It can even delay the need for surgery.
The aim of this study is to perform a randomized, prospective, interventional, 3-arm parallel group study to look at the difference in outcome in knee osteoarthritic patient with the use of the new semi-rigid offloading brace versus knee brace comparator versus without orthosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- An interventional, prospective, monocentric, randomized, open and controlled study
| Arm | Type | Receives |
|---|---|---|
| Group I with UniRelieverTM offloading brace | Experimental | Device: UniRelieverTM offloading brace (THUASNE)Patients wearing the UniRelieverTM offloading brace (THUASNE): For intervention group I, in addition to the usual care described above for the control group, patients will wear the studied UniRelieverTM offloading brace. |
| Group II with Unloader One® X brace | Experimental | Device: Unloader One® X brace (Össur)Patients wearing the Unloader One® X brace (Össur): For intervention group II, in addition to the usual care described above for the control group, patients will wear the Unloader One® X brace by Össur |
| Group III without orthosis | No intervention | –Patients wearing no orthosis: In the control group, usual care is defined by: * buffer heel and/or * insoles and/or * outer edge raisin and/or * walking stick and/or * physiotherapy and/ or * analgesics oral and local depending on the patient's needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Medial femorotibial knee osteoarthritis grade 2, 3 or 4 according to the Kellgren Lawrence system
- Visual Analog Scale pain ≥ 40/100 in the last 48 hours
- Signed informed consent prior to any study-mandated procedure.
- Affiliated to the General regime of the Social Security or covered by a similar health insurance system
Key exclusion criteria (9 listed)
- Inability to walk or dependance on a wheelchair or use of crutches.
- Diseases that do not allow participation in the study for a period of six weeks.
- Concomitant ipsilateral patellofemoral osteoarthritis associated with a more severe pain than the one for medial OA.
- Ipsilateral osteoarthritis of the hip associated with a more severe pain than the one for medial OA.
- A body mass index over 35.
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 |
|---|---|---|
| UniRelieverTM offloading brace (THUASNE)The patient will be instructed to wear the brace during walking and physical exercise. The investigator will explain to the patient how to adjust it | Device | Group I with UniRelieverTM offloading brace |
| Unloader One® X brace (Össur)The patient will be instructed to wear the brace during walking and physical exercise. The investigator will explain to the patient how to adjust it | Device | Group II with Unloader One® X brace |
Primary outcome
Pain-free walking distance
Time frame: 6 weeks
The evolution of pain-free walking distance evaluated by reporting the distance that the patient can walk without pain.
10 secondary outcomes
Knee functional capacity
Time frame: 6 weeks
Pain on loading
Time frame: 6 weeks
Pain at rest
Time frame: 6 weeks
Analgesic consumption
Time frame: 6 weeks
Subjective range of movement
Time frame: 6 weeks
Objective range of movement
Time frame: 6 weeks
Assessment of Patient's Global Impression of Change (PGI-C)
Time frame: 6 weeks
Assessment of compliance
Time frame: 6 weeks
Assessment of patient's satisfaction
Time frame: 6 weeks
Assessment of safety (AE and SAEs)
Time frame: 6 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 17 Apr 2024.
- Background: PubMed 27939833Beaudreuil J. Orthoses for osteoarthritis: A narrative review. Ann Phys Rehabil Med. 2017 Apr;60(2):102-106. doi: 10.1016/j.rehab.2016.10.005. Epub 2016 Dec 6.
- Background: PubMed 29736571Grazina R, Andrade R, Bastos R, Costa D, Pereira R, Marinhas J, Maestro A, Espregueira-Mendes J. Clinical Management in Early OA. Adv Exp Med Biol. 2018;1059:111-135. doi: 10.1007/978-3-319-76735-2_5.
- Background: 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.
- Background: PubMed 25160784Maleki M, Arazpour M, Joghtaei M, Hutchins SW, Aboutorabi A, Pouyan A. The effect of knee orthoses on gait parameters in medial knee compartment osteoarthritis: A literature review. Prosthet Orthot Int. 2016 Apr;40(2):193-201. doi: 10.1177/0309364614547411. Epub 2014 Aug 26.
- Background: PubMed 31168421Parween R, Shriram D, Mohan RE, Lee YHD, Subburaj K. Methods for evaluating effects of unloader knee braces on joint health: a review. Biomed Eng Lett. 2019 Jan 23;9(2):153-168. doi: 10.1007/s13534-019-00094-z. eCollection 2019 May.
- Background: PubMed 30255369Petersen W, Ellermann A, Henning J, Nehrer S, Rembitzki IV, Fritz J, Becher C, Albasini A, Zinser W, Laute V, Ruhnau K, Stinus H, Liebau C. Non-operative treatment of unicompartmental osteoarthritis of the knee: a prospective randomized trial with two different braces-ankle-foot orthosis versus knee unloader brace. Arch Orthop Trauma Surg. 2019 Feb;139(2):155-166. doi: 10.1007/s00402-018-3040-8. Epub 2018 Sep 25.
- Background: PubMed 15094138Pham T, van der Heijde D, Altman RD, Anderson JJ, Bellamy N, Hochberg M, Simon L, Strand V, Woodworth T, Dougados M. OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage. 2004 May;12(5):389-99. doi: 10.1016/j.joca.2004.02.001.
- Background: PubMed 21273902Raja K, Dewan N. Efficacy of knee braces and foot orthoses in conservative management of knee osteoarthritis: a systematic review. Am J Phys Med Rehabil. 2011 Mar;90(3):247-62. doi: 10.1097/PHM.0b013e318206386b.
- Derived from this study: PubMed 41331771Benning M, Villet S, Marques A, Hilgers RD. The effectiveness of the UniReliever offloading knee brace for treating medial knee osteoarthritis: A randomized clinical trial. Prosthet Orthot Int. 2026 Aug 1;50(4):426-433. doi: 10.1097/PXR.0000000000000503. Epub 2025 Dec 3.
- COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Michael Benning, MD principal investigator
Trauma Orthopedic Surgery Practice Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UniRelieverTM offloading brace (THUASNE) and Unloader One® X brace (Össur) in people with Osteoarthritis, Knee, run by Thuasne at 1 site in Germany.
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 5 inclusion and 9 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 17 Apr 2024. 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 Germany. 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-free walking distance (time frame: 6 weeks). 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 NCT05905809, which also lists 9 linked publications.
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 17 Apr 2024.