Study of Biomechanical Parameters of Unloading Braces Used in the Treatment of Knee Osteoarthritis (BIOoSE)
BIOoSE
2 other identifiers
interventional
13
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable knee-osteoarthritis
Started Feb 2018
Typical duration for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedFirst Submitted
Initial submission to the registry
August 20, 2020
CompletedFirst Posted
Study publicly available on registry
August 24, 2020
CompletedAugust 24, 2020
August 1, 2020
1.5 years
August 20, 2020
August 21, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Day : 1
Secondary Outcomes (6)
Perceived pain
Day: 1
Adduction/abduction angles
Day: 1
Impact and propulsive reaction force of the ground
Day: 1
Step length
Day: 1
Walking speed
Day: 1
- +1 more secondary outcomes
Study Arms (4)
Rebel Reliever
EXPERIMENTALRebel 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
EXPERIMENTALAction 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 COMPARATORUnloader 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 INTERVENTIONControl condition without brace
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- limited ability to walk
- normoaxial knee alignment
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thuasnelead
- University Hospital of Saint-Etiennecollaborator
- Laboratoire Interuniversitaire de Biologie de la Motricitécollaborator
Study Sites (1)
Saint-Etienne Jean Monnet University
Saint-Etienne, 42270, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thierry Thomas, MD
CHU SAINT-ETIENNE
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2020
First Posted
August 24, 2020
Study Start
February 1, 2018
Primary Completion
July 31, 2019
Study Completion
March 31, 2020
Last Updated
August 24, 2020
Record last verified: 2020-08