Knee OsteoarthritisBIOoSENCT04524845
Study of Biomechanical Parameters of Unloading Braces Used in the Treatment of Knee Osteoarthritis (BIOoSE)
A study testing Unloading brace, Rebel Reliever (RR) and Action Reliever in people with Knee Osteoarthritis, run by Thuasne at 1 site in France.
Trial summary
Osteoarthritis is a chronic disease affecting millions of people worldwide, and knee is the second most affected site. Knee osteoarthritis is characterized by knee pain, loss of motion, disability, and muscle weakness, all factors contributing to gait alterations, and impacting greatly the patients quality of life. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Unloading brace, Rebel Reliever (RR) and Action Reliever
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2018to 31 Mar 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral medial KOA classified II or III on the Kellgren-Lawrence scale
- varus misalignment with a joint space of at least two finger breadths
- pain level equal or higher than 30 mm on a 100 mm visual analog scale
- informed written consent
Who cannot join
- limited ability to walk
- normoaxial knee alignment
- intra-articular injection of a local treatment including corticosteroids in the 3 months or hyaluronic acid in the 6 months preceding its inclusion or analgesic or NSAID treatment with a wash-out period equal to 5 half-lives of the drug concerned
- undergoing physiotherapy
- cognitive disorders or behavioral disorders (opposition, agitation, dementia)
- arteriopathy of the lower limbs
- skin disorders contraindicating the wearing of rigid orthotics
- severe varicosity preventing the regular wearing of unloading brace
Trial locations and contacts
1 site in 1 country.
About this study
Osteoarthritis is a chronic disease affecting millions of people worldwide, and knee is the second most affected site. Knee osteoarthritis is characterized by knee pain, loss of motion, disability, and muscle weakness, all factors contributing to gait alterations, and impacting greatly the patients quality of life. In the absence of curative treatment, pharmacological and non-pharmacological symptomatic treatments are prescribed to maintain this QoL, and therefore delay surgery to more appropriate window of opportunity later in life.
The aim of the study was to investigate the acute effects of three braces, using different unloading strategies, on gait kinematic and kinetic parameters, as well as pain in patients with medial knee ostoeoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- Unloading brace, Rebel Reliever (RR), Action Reliever
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unloading braceDevice
Participants underwent one session of gait analysis. The experimental protocol was divided in four conditions, the control condition without brace (NO), and then three conditions with the different braces tested in a randomized order.
For each condition, the participant was fitted with the brace by the same experimenter and equipped with 19/20 retro-reflective markers (without/with brace) on the pelvis and the investigated leg for motion analysis. After a short recording in a fixed standing position (static trial), each participant carried out at least three barefoot walking trials of a few meters long at a self-selected pace. The walking trial was validated if a complete gait cycle occurred on the two 90cm x 90 cm force plates recording the ground reaction forces. After each condition, the participant had to assess knee pain.
Rebel Reliever (RR)Device
Rebel Reliever (RR) (Thuasne, Levallois Perret, France)
Action RelieverDevice
Action Reliever (AR) (Thuasne, Levallois Perret, France)
| Study group | Role | What they receive |
|---|---|---|
| Rebel Reliever | Experimental | Rebel Reliever (RR) (Thuasne, Levallois Perret, France) with bilateral rigid frames and two hinges. The valgus correction was set by adjusting the medial and lateral frame lengths to a difference of two or three points as dictated by the participant's feeling and comfort. Six straps maintained the brace in place Receives: Device: Rebel Reliever (RR) |
| Action Reliever | Experimental | Action Reliever (AR) (Thuasne, Levallois Perret, France) made mainly from textile. Upper and lower straps were adjusted to the participant's feeling and comfort. Receives: Device: Action Reliever |
| Unloader One | Active comparator | Unloader One (UO) (Össur, Reykjavik, Iceland), with unilateral frame and one hinge. Upper and lower straps were adjusted to the setting recommended by the fitting instructions and confirmed by the participant's sensation. Receives: Device: Unloading brace |
| No orthosis | No intervention | Control condition without brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Adduction Moment
Main parameter determined from the force platforms:
- Position of the center of gravity
By coupling the techniques of kinematic measurement and ground reaction force, we obtain the Moment of Adduction (or KAM) when walking
Measured: Day : 1
Knee Adduction Moment
Main parameter determined from the force platforms:
- Impact force and vertical propulsive force. By coupling the techniques of kinematic measurement and ground reaction force, we obtain the Moment of Adduction (or KAM) when walking
Measured: Day : 1
Secondary outcomes (6)
Perceived pain
The pain is self-assessed by the patient using a visual analogue scale graduated from 0 to 10: the analogue scale is presented to the patients, who will mark the level of pain felt during the works under each of the study conditions.
Measured: Day: 1
Adduction/abduction angles
Adduction/abduction angles (in particular A1 and A2, corresponding to the two vertical GRF maxima, as well as the adduction angle during standing (A0)), were measured (deg) under each condition.
Measured: Day: 1
Impact and propulsive reaction force of the ground
The impact force and the propulsive reaction force of the ground (N / kg) were measured during walking under each condition. F1 corresponds to the load response peak and F2 to the terminal stance peak during gait,
Measured: Day: 1
Step length
The length of the step (m) was measured during walking under each condition.
Measured: Day: 1
Walking speed
The walking distance (km/h) was measured during walking under each condition.
Measured: Day: 1
Satisfaction related to the device
A satisfaction survey is filled by the patient in order to assess the positioning of unloading brace, comfort, esthetic and global satisfaction of devices
Measured: Day: 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start1 Feb 2018
- Primary completion31 Jul 2019
- Study completion31 Mar 2020
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.
- 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
- Crossover
- Model description
- Randomized, cross-over, open labelled, monocentric, controlled trial
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thuasne
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital of Saint-Etienne, Laboratoire Interuniversitaire de Biologie de la Motricité
- Responsible party
- Sponsor
- Investigators
- Thierry Thomas, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524845
- Sponsor's protocol ID
- EC25
- Other IDs
- 2017-A01963-50
- Acronym
- BIOoSE
- Status last verified
- Aug 2020
- First submitted
- 20 Aug 2020
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Biomechanical Parameters of Unloading Braces Used in the Treatment of Knee Osteoarthritis (BIOoSE)
- ClinicalTrials.gov ID
- NCT04524845
- Acronym / sponsor ID
- BIOoSE / EC25
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- ThuasneIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital of Saint-Etienne, Laboratoire Interuniversitaire de Biologie de la Motricité
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 24 Aug 2020 (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.
Osteoarthritis is a chronic disease affecting millions of people worldwide, and knee is the second most affected site. Knee osteoarthritis is characterized by knee pain, loss of motion, disability, and muscle weakness, all factors contributing to gait alterations, and impacting greatly the patients quality of life. In the absence of curative treatment, pharmacological and non-pharmacological symptomatic treatments are prescribed to maintain this QoL, and therefore delay surgery to more appropriate window of opportunity later in life.
The aim of the study was to investigate the acute effects of three braces, using different unloading strategies, on gait kinematic and kinetic parameters, as well as pain in patients with medial knee ostoeoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized, cross-over, open labelled, monocentric, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Rebel Reliever | Experimental | Device: Rebel Reliever (RR)Rebel Reliever (RR) (Thuasne, Levallois Perret, France) with bilateral rigid frames and two hinges. The valgus correction was set by adjusting the medial and lateral frame lengths to a difference of two or three points as dictated by the participant's feeling and comfort. Six straps maintained the brace in place |
| Action Reliever | Experimental | Device: Action RelieverAction Reliever (AR) (Thuasne, Levallois Perret, France) made mainly from textile. Upper and lower straps were adjusted to the participant's feeling and comfort. |
| Unloader One | Active comparator | Device: Unloading braceUnloader One (UO) (Össur, Reykjavik, Iceland), with unilateral frame and one hinge. Upper and lower straps were adjusted to the setting recommended by the fitting instructions and confirmed by the participant's sensation. |
| No orthosis | No intervention | –Control condition without brace |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- unilateral medial KOA classified II or III on the Kellgren-Lawrence scale
- varus misalignment with a joint space of at least two finger breadths
- pain level equal or higher than 30 mm on a 100 mm visual analog scale
- informed written consent
Key exclusion criteria (8 listed)
- limited ability to walk
- normoaxial knee alignment
- intra-articular injection of a local treatment including corticosteroids in the 3 months or hyaluronic acid in the 6 months preceding its inclusion or analgesic or NSAID treatment with a wash-out period equal to 5 half-lives of the drug concerned
- undergoing physiotherapy
- cognitive disorders or behavioral disorders (opposition, agitation, dementia)
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 |
|---|---|---|
| Unloading braceParticipants underwent one session of gait analysis. The experimental protocol was divided in four conditions, the control condition without brace (NO), and then three conditions with the different braces tested in a randomized order. For each condition, the participant was fitted with the brace by the same experimenter and equipped with 19/20 retro-reflective markers (without/with brace) on the pelvis and the investigated leg for motion analysis. After a short recording in a fixed standing position (static trial), each participant carried out at least three barefoot walking trials of a few meters long at a self-selected pace. The walking trial was validated if a complete gait cycle occurred on the two 90cm x 90 cm force plates recording the ground reaction forces. After each condition, the participant had to assess knee pain. | Device | Unloader One |
| Rebel Reliever (RR)Rebel Reliever (RR) (Thuasne, Levallois Perret, France) | Device | Rebel Reliever |
| Action RelieverAction Reliever (AR) (Thuasne, Levallois Perret, France) | Device | Action Reliever |
Primary outcome
Knee Adduction Moment
Time frame: Day : 1
Main parameter determined from the force platforms: - Position of the center of gravity By coupling the techniques of kinematic measurement and ground reaction force, we obtain the Moment of Adduction (or KAM) when walking
Knee Adduction Moment
Time frame: Day : 1
Main parameter determined from the force platforms: - Impact force and vertical propulsive force. By coupling the techniques of kinematic measurement and ground reaction force, we obtain the Moment of Adduction (or KAM) when walking
6 secondary outcomes
Perceived pain
Time frame: Day: 1
Adduction/abduction angles
Time frame: Day: 1
Impact and propulsive reaction force of the ground
Time frame: Day: 1
Step length
Time frame: Day: 1
Walking speed
Time frame: Day: 1
Satisfaction related to the device
Time frame: Day: 1
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 Aug 2020.
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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.
Thierry Thomas, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unloading brace, Rebel Reliever (RR) and Action Reliever in people with Knee Osteoarthritis, run by Thuasne 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 4 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 Aug 2020. 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?
Knee Adduction Moment (time frame: Day : 1). 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 Aug 2020.