Study of Biomechanical Parameters of Unloading Braces Used in the Treatment of Knee Osteoarthritis (BIOoSE)

THUASNE

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Device: Rebel Reliever (RR); Device: Action Reliever; Device: Unloading brace

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04524845

2017-A01963-50 (Other Identifier)

EC25

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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13 participants in 4 patient groups

Rebel Reliever

Experimental group

Description:

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

Treatment:

Device: Rebel Reliever (RR)

Action Reliever

Experimental group

Description:

Action Reliever (AR) (Thuasne, Levallois Perret, France) made mainly from textile. Upper and lower straps were adjusted to the participant's feeling and comfort.

Treatment:

Device: Action Reliever

Unloader One

Active Comparator group

Description:

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.

Treatment:

Device: Unloading brace

No orthosis

No Intervention group

Description:

Control condition without brace