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

Knee Osteoarthritis Clinical Trial

— BIOoSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04524845
• Other study ID #: EC25
• Secondary ID: 2017-A01963-50
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: August 2020
• Source: Thuasne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 31, 2020
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Unloading brace
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.
• Rebel Reliever (RR)
Rebel Reliever (RR) (Thuasne, Levallois Perret, France)
• Action Reliever
Action Reliever (AR) (Thuasne, Levallois Perret, France)

Locations

Country	Name	City	State
France	Saint-Etienne Jean Monnet University	Saint-Etienne

Sponsors (3)

Lead Sponsor	Collaborator
Thuasne	Laboratoire Interuniversitaire de Biologie de la Motricité, University Hospital of Saint-Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Perceived pain	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.	Day: 1
Secondary	Adduction/abduction angles	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.	Day: 1
Secondary	Impact and propulsive reaction force of the ground	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,	Day: 1
Secondary	Step length	The length of the step (m) was measured during walking under each condition.	Day: 1
Secondary	Walking speed	The walking distance (km/h) was measured during walking under each condition.	Day: 1
Secondary	Satisfaction related to the device	A satisfaction survey is filled by the patient in order to assess the positioning of unloading brace, comfort, esthetic and global satisfaction of devices	Day: 1