Clinical trial NCT04524845: Study of Biomechanical Parameters of Unloading Braces Used in the Treatment of Knee Osteoarthritis (BIOoSE)
Official title: Study of Biomechanical Parameters of Unloading Braces Used in the Treatment of Knee Osteoarthritis (BIOoSE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Thuasne
Sponsor class: INDUSTRY
Collaborators: name: University Hospital of Saint-Etienne
name: Laboratoire Interuniversitaire de Biologie de la Motricité
First posted: 2020-08-24
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, cross-over, open labelled, monocentric, controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Knee Adduction Moment
timeFrame: Day : 1
measure: Knee Adduction Moment
timeFrame: Day : 1
Secondary outcomes:
measure: Perceived pain
timeFrame: Day: 1
measure: Adduction/abduction angles
timeFrame: Day: 1
measure: Impact and propulsive reaction force of the ground
timeFrame: Day: 1
measure: Step length
timeFrame: Day: 1
measure: Walking speed
timeFrame: Day: 1
measure: Satisfaction related to the device
timeFrame: Day: 1
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: Saint-Etienne Jean Monnet University
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Thierry Thomas, MD
role: PRINCIPAL_INVESTIGATOR
References: