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Completed

NCT Number: NCT04524845

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint-Etienne Jean Monnet University

Saint-Etienne, 42270, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unloading brace

Device

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)

Device

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

Action Reliever

Device

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

Primary outcomes

  1. Knee Adduction Moment

    Time frame: Day : 1

    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

  2. Knee Adduction Moment

    Time frame: 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 outcomes

  1. Perceived pain

    Time frame: 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.

  2. Adduction/abduction angles

    Time frame: 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.

  3. Impact and propulsive reaction force of the ground

    Time frame: 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,

  4. Step length

    Time frame: Day: 1

    The length of the step (m) was measured during walking under each condition.

  5. Walking speed

    Time frame: Day: 1

    The walking distance (km/h) was measured during walking under each condition.

  6. Satisfaction related to the device

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Thuasne

Industry

Collaborators

  • Laboratoire Interuniversitaire de Biologie de la Motricité
  • University Hospital of Saint-Etienne

Registry information

Acronym: BIOoSE

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Aug 24, 2020
Registry last updated
Aug 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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