Medial Gonarthrosis
Conditions
Keywords
knee orthosis, knee brace, validation, WOMAC, knee pain, knee stiffness, daily activities, knee function
Brief summary
The aging population is steadily increasing, partly due to increasing life expectancy. At the same time, chronic diseases, including those affecting the musculoskeletal system (e.g., osteoarthritis), whose prevalence increases with age, limit the daily activities of those affected and thus affect more and more people. Arthrosis is the most common form of these diseases worldwide. According to the l'Institut de la statistique du Québec, nearly one in two Quebecers aged 15 and over is affected by a chronic health problem. Knee orthosis is one form of treatment that helps patients suffering from knee gonarthrosis. This treatment aims to compensate for certain biomechanical deficits in patients. A variety of joint configurations exists to target specific biomechanical deficits. A constant challenge for companies manufacturing orthoses is transmitting the orthosis's biomechanical effect to the patient. The desired effect requires a change in the forces applied inside the knee, but the orthosis cannot directly transmit forces to the patient's bones due to its external nature to the body. Customization of orthoses is crucial to improve the transmission of the biomechanical effect as well as tolerance to it. O3D Inc. aims to validate the effectiveness of its new custom orthosis for treating knee gonarthrosis symptoms. Participants answered a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire before receiving their custom knee brace(Baseline) and after 8 weeks (56 days) of treatment.
Interventions
DEVICEcustom knee orthosis
The custom knee orthosis will be worn for 8 weeks (56 days).
Sponsors
Natural Sciences and Engineering Research Council, Canada
O3D inc.
TOPMED
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Longitudal treatment validation
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Suffering from medial gonarthrosis * Receiving a regular model of the O3D orthosis
Exclusion criteria
* Suffering from tricompartmental gonarthosis * Having completed the delivery appointment for a O3D orthosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in WOMAC Total Score | At baseline and after 8 weeks of intervention(Day 56) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 24 item questionnaire about knee pain, stiffness and function. Each item uses a 5 point scale ranging from 0 (no pain, stiffness or difficulty) to 4 (extreme pain, stiffness or difficulty). Total score is the sum of all items and ranges from 0 to 96. Therefore low scores represent better knee health whereas high scores represent worse knee health. Change is calculated as : Change= Score after 8 weeks of treatment - Baseline Score |
| Change in WOMAC Pain Score | At baseline and after 8 weeks of intervention(Day 56) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subcore of 5 items about knee pain. Each item uses a 5 point scale ranging from 0 (no pain) to 4 (extreme pain). Pain score is the sum of all 5 items, ranges from 0 to 20. Therefore low scores represent better knee pain whereas high scores represent worse knee pain. Change is calculated as : Change= Score after 8 weeks of treatment - Baseline Score |
| Change in WOMAC Stiffness Score | At baseline and after 8 weeks of intervention(Day 56) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscore of 2 items about knee stiffness. Each item uses a 5 point scale ranging from 0 (no stiffness) to 4 (extreme stiffness). Stiffness score is the sum of 2 items, ranges from 0 to 8. Therefore low scores represent better knee stiffness whereas high scores represent worse knee stiffness. Change is calculated as : Change= Score after 8 weeks of treatment - Baseline Score |
| Change in WOMAC Physical Function Score | At baseline and after 8 weeks of intervention(Day 56) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscore of 17 items about knee function. Each item uses a 5 point scale ranging from 0 (no dificulty) to 4 (extreme dificulty). Functionnal limitation score is the sum of all 17 items, ranges from 0 to 68. Therefore low scores represent better knee function whereas high scores represent worse knee function. Change is calculated as : Change= Score after 8 weeks of treatment - Baseline Score |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Medial Gonarthrosis Patients with medial gonarthrosis
custom knee orthosis: The custom knee orthosis will be worn for 8 weeks. | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Medial Gonarthrosis | — |
|---|---|---|
| Age, Customized 18<age<75 | 1 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 1 participants | — |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
| WOMAC Pain score | 10 units on a scale STANDARD_DEVIATION 0 | — |
| WOMAC Physical Function Score | 37 units on a scale STANDARD_DEVIATION 0 | — |
| WOMAC Stiffness Score | 5 units on a scale STANDARD_DEVIATION 0 | — |
| WOMAC Total Score | 52 units on a scale STANDARD_DEVIATION 0 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Change in WOMAC Pain Score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subcore of 5 items about knee pain. Each item uses a 5 point scale ranging from 0 (no pain) to 4 (extreme pain). Pain score is the sum of all 5 items, ranges from 0 to 20. Therefore low scores represent better knee pain whereas high scores represent worse knee pain. Change is calculated as : Change= Score after 8 weeks of treatment - Baseline Score
Time frame: At baseline and after 8 weeks of intervention(Day 56)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medial Gonarthrosis | Change in WOMAC Pain Score | 3 units on a scale | Standard Deviation 0 |
Primary
Change in WOMAC Physical Function Score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscore of 17 items about knee function. Each item uses a 5 point scale ranging from 0 (no dificulty) to 4 (extreme dificulty). Functionnal limitation score is the sum of all 17 items, ranges from 0 to 68. Therefore low scores represent better knee function whereas high scores represent worse knee function. Change is calculated as : Change= Score after 8 weeks of treatment - Baseline Score
Time frame: At baseline and after 8 weeks of intervention(Day 56)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medial Gonarthrosis | Change in WOMAC Physical Function Score | 2 units on a scale | Standard Deviation 0 |
Primary
Change in WOMAC Stiffness Score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscore of 2 items about knee stiffness. Each item uses a 5 point scale ranging from 0 (no stiffness) to 4 (extreme stiffness). Stiffness score is the sum of 2 items, ranges from 0 to 8. Therefore low scores represent better knee stiffness whereas high scores represent worse knee stiffness. Change is calculated as : Change= Score after 8 weeks of treatment - Baseline Score
Time frame: At baseline and after 8 weeks of intervention(Day 56)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medial Gonarthrosis | Change in WOMAC Stiffness Score | 1 units on a scale | Standard Deviation 0 |
Primary
Change in WOMAC Total Score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 24 item questionnaire about knee pain, stiffness and function. Each item uses a 5 point scale ranging from 0 (no pain, stiffness or difficulty) to 4 (extreme pain, stiffness or difficulty). Total score is the sum of all items and ranges from 0 to 96. Therefore low scores represent better knee health whereas high scores represent worse knee health. Change is calculated as : Change= Score after 8 weeks of treatment - Baseline Score
Time frame: At baseline and after 8 weeks of intervention(Day 56)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medial Gonarthrosis | Change in WOMAC Total Score | 6 units on a scale | Standard Deviation 0 |