Status:
COMPLETED
Study of Biomechanical Parameters of Unloading Braces Used in the Treatment of Knee Osteoarthritis (BIOoSE)
Lead Sponsor:
Thuasne
Collaborating Sponsors:
University Hospital of Saint-Etienne
Laboratoire Interuniversitaire de Biologie de la Motricité
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18-75 years
Phase:
NA
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, an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04524845
Start Date
February 1 2018
End Date
March 31 2020
Last Update
August 24 2020
Active Locations (1)
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1
Saint-Etienne Jean Monnet University
Saint-Etienne, France, 42270