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

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.

Conditions

• Knee Osteoarthritis

Interventions

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.

DEVICE

Rebel Reliever (RR)

Rebel Reliever (RR) (Thuasne, Levallois Perret, France)

DEVICE

Action Reliever

Action Reliever (AR) (Thuasne, Levallois Perret, France)

Sponsors & Collaborators

• University Hospital of Saint-Etienne

  collaborator OTHER

• Laboratoire Interuniversitaire de Biologie de la Motricité

  collaborator OTHER

• Thuasne

  lead INDUSTRY

Principal Investigators

• Thierry Thomas, MD · CHU SAINT-ETIENNE

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-01

Primary Completion

2019-07-31

Completion

2020-03-31

Countries

• France

Study Locations