Study of Biomechanical Parameters of Unloading Braces Used in the Treatment of Knee Osteoarthritis (BIOoSE)
- Conditions
- Knee Osteoarthritis
- Interventions
- Device: Unloading braceDevice: Action RelieverDevice: Rebel Reliever (RR)
- Registration Number
- NCT04524845
- Lead Sponsor
- Thuasne
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Unloader One Unloading brace 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. Action Reliever Action Reliever Action Reliever (AR) (Thuasne, Levallois Perret, France) made mainly from textile. Upper and lower straps were adjusted to the participant's feeling and comfort. Rebel Reliever 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
- Primary Outcome Measures
Name Time Method Knee Adduction Moment 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
- Secondary Outcome Measures
Name Time Method Step length Day: 1 The length of the step (m) was measured during walking under each condition.
Impact and propulsive reaction force of the ground Day: 1 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,
Satisfaction related to the device Day: 1 A satisfaction survey is filled by the patient in order to assess the positioning of unloading brace, comfort, esthetic and global satisfaction of devices
Perceived pain Day: 1 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.
Adduction/abduction angles Day: 1 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.
Walking speed Day: 1 The walking distance (km/h) was measured during walking under each condition.
Trial Locations
- Locations (1)
Saint-Etienne Jean Monnet University
🇫🇷Saint-Etienne, France