Medial Compartment Knee Osteoarthritis
Conditions
Keywords
Knee Brace, Osteoarthritis, Joint Distraction
Brief summary
The Effect of a Novel Joint Distraction Knee Orthosis for Treating Medial Knee Osteoarthritis
Interventions
DEVICEMedial joint distraction brace
Patients will receive Icarus Adonis Joint Distraction brace.
Sponsors
Icarus Medical Innovations
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 30-70, as significant knee OA is very common for people under 30, and would be more likely correlated to trauma. * Able to ambulate with or without assistive devices * Body-mass index (BMI) under 35. This is to minimize the effect of the variable of how the brace fits on the patient. The finding of pain relief will extrapolate to any BMI. * Willingness and ability to comply with scheduled visits and study procedures * Willingness and ability to fill out patient questionnaires written in English * Ability to provide informed consent * Clinical diagnosis of medial or lateral compartment knee osteoarthritis requiring a KO. * Subject is suitable for unilateral bracing
Exclusion criteria
* Significant cognitive impairment interfering with study assessments * Active infections or wounds at the foot or leg * Severe spasticity that limits brace fitting or functioning * History of severe lower limb deformities that would preclude brace use * History of major joint surgery or joint implants, such as total knee replacement * Other neurological or musculoskeletal conditions unrelated to the lower limbs that significantly impact gait * Non-ambulatory * Inability to travel for study procedures or fill out required surveys * Medical conditions of interest * Pregnant women * Prisoners * Clinical diagnosis of knee osteoarthritis that is not specific to the knee's medial or lateral compartment (multicompartmental, or patellofemoral knee osteoarthritis) * Self-reported pain score of less than 3 out of 10 in the medial compartment. * Varus or valgus deformity greater than 12° * Inability to read/write/communicate in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline, 2, 4, 8, 12 weeks | Scored 0 to 100, where 0 represents total knee disability and 100 represents perfect knee |
| European Quality of Life-5 Dimensions (EQ-5D-5L) | Baseline, 2, 4, 8, 12 weeks. | 0 to 1, where 1 is perfect health |
| Visual Analogue Scale (VAS) | Baseline, 2, 4, 8, 12 weeks. | 0-100, zero meaning no pain, 10 meaning severe pain |
| Functional Mobility Assessments | Baseline, 2, 4, 8, 12 weeks | 6 minute walk test |
| Functional Mobility Assessment | Baseline, 2, 4, 8, 12 weeks | 5 times Sit to Stand test |
Countries
United States
Contacts
CONTACTBenjamin M Koerber, PhD
CONTACTEvan Eckersley
Outcome results
None listed