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

NCT ID: NCT04524845

Last Updated: 2020-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2020-03-31

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rebel Reliever

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

Group Type: EXPERIMENTAL

Rebel Reliever (RR)

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Action Reliever

Intervention Type: DEVICE

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

Unloader One

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.

Group Type: ACTIVE_COMPARATOR

Unloading brace

Intervention Type: 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.

No orthosis

Control condition without brace

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Rebel Reliever (RR)

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

Intervention Type: DEVICE

Action Reliever

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Saint-Etienne

OTHER

Sponsor Role: collaborator

Laboratoire Interuniversitaire de Biologie de la Motricité

OTHER

Sponsor Role: collaborator

Thuasne

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thierry Thomas, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Saint-Etienne Jean Monnet University

Saint-Etienne, , France

Countries

France

Other Identifiers

2017-A01963-50

Identifier Type: OTHER

Identifier Source: secondary_id

EC25

Identifier Type: -

Identifier Source: org_study_id