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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Unloading brace
Rebel Reliever (RR)
Action Reliever
Sponsored by
Thuasne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Saint-Etienne Jean Monnet University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

No Intervention

Arm Label

Rebel Reliever

Action Reliever

Unloader One

No orthosis

Arm 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

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

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.

Control condition without brace

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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.
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.
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,
Step length
The length of the step (m) was measured during walking under each condition.
Walking speed
The walking distance (km/h) was measured during walking under each condition.
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

Full Information

First Posted
August 20, 2020
Last Updated
August 21, 2020
Sponsor
Thuasne
Collaborators
University Hospital of Saint-Etienne, Laboratoire Interuniversitaire de Biologie de la Motricité
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1. Study Identification

Unique Protocol Identification Number
NCT04524845
Brief Title
Study of Biomechanical Parameters of Unloading Braces Used in the Treatment of Knee Osteoarthritis (BIOoSE)
Acronym
BIOoSE
Official Title
Study of Biomechanical Parameters of Unloading Braces Used in the Treatment of Knee Osteoarthritis (BIOoSE)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thuasne
Collaborators
University Hospital of Saint-Etienne, Laboratoire Interuniversitaire de Biologie de la Motricité

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, cross-over, open labelled, monocentric, controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rebel Reliever
Arm Type
Experimental
Arm 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
Arm Title
Action Reliever
Arm Type
Experimental
Arm 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.
Arm Title
Unloader One
Arm Type
Active Comparator
Arm 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.
Arm Title
No orthosis
Arm Type
No Intervention
Arm Description
Control condition without brace
Intervention Type
Device
Intervention Name(s)
Unloading brace
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Rebel Reliever (RR)
Intervention Description
Rebel Reliever (RR) (Thuasne, Levallois Perret, France)
Intervention Type
Device
Intervention Name(s)
Action Reliever
Intervention Description
Action Reliever (AR) (Thuasne, Levallois Perret, France)
Primary Outcome Measure Information:
Title
Knee Adduction Moment
Description
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
Time Frame
Day : 1
Title
Knee Adduction Moment
Description
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
Time Frame
Day : 1
Secondary Outcome Measure Information:
Title
Perceived pain
Description
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.
Time Frame
Day: 1
Title
Adduction/abduction angles
Description
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.
Time Frame
Day: 1
Title
Impact and propulsive reaction force of the ground
Description
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,
Time Frame
Day: 1
Title
Step length
Description
The length of the step (m) was measured during walking under each condition.
Time Frame
Day: 1
Title
Walking speed
Description
The walking distance (km/h) was measured during walking under each condition.
Time Frame
Day: 1
Title
Satisfaction related to the device
Description
A satisfaction survey is filled by the patient in order to assess the positioning of unloading brace, comfort, esthetic and global satisfaction of devices
Time Frame
Day: 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Thomas, MD
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint-Etienne Jean Monnet University
City
Saint-Etienne
ZIP/Postal Code
42270
Country
France

12. IPD Sharing Statement

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

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