Study of Biomechanical Parameters of Unloading Braces Used in the Treatment of Knee Osteoarthritis (BIOoSE) (BIOoSE)
Knee Osteoarthritis
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
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
Sites / Locations
- Saint-Etienne Jean Monnet University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
No Intervention
Rebel Reliever
Action Reliever
Unloader One
No orthosis
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 (AR) (Thuasne, Levallois Perret, France) made mainly from textile. Upper and lower straps were adjusted to the participant's feeling and comfort.
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.
Control condition without brace