Trial Outcomes & Findings for Validating the Clinical Effect of a Knee Orthosis (NCT NCT06655558)
NCT ID: NCT06655558
Last Updated: 2025-09-04
Results Overview
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
TERMINATED
NA
2 participants
At baseline and after 8 weeks of intervention(Day 56)
2025-09-04
Participant Flow
Participant milestones
| Measure |
Medial Gonarthrosis
Patients with medial gonarthrosis
custom knee orthosis: The custom knee orthosis will be worn for 8 weeks.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Medial Gonarthrosis
Patients with medial gonarthrosis
custom knee orthosis: The custom knee orthosis will be worn for 8 weeks.
|
|---|---|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Medial Gonarthrosis
n=1 Participants
Patients with medial gonarthrosis
custom knee orthosis: The custom knee orthosis will be worn for 8 weeks.
|
|---|---|
|
Age, Customized
18<age<75
|
1 Participants
n=1 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=1 Participants
|
|
WOMAC Total Score
|
52 units on a scale
STANDARD_DEVIATION 0 • n=1 Participants
|
|
WOMAC Pain score
|
10 units on a scale
STANDARD_DEVIATION 0 • n=1 Participants
|
|
WOMAC Stiffness Score
|
5 units on a scale
STANDARD_DEVIATION 0 • n=1 Participants
|
|
WOMAC Physical Function Score
|
37 units on a scale
STANDARD_DEVIATION 0 • n=1 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Medial Gonarthrosis
n=1 Participants
Patients with medial gonarthrosis
custom knee orthosis: The custom knee orthosis will be worn for 8 weeks.
|
|---|---|
|
Change in WOMAC Total Score
|
6 units on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Medial Gonarthrosis
n=1 Participants
Patients with medial gonarthrosis
custom knee orthosis: The custom knee orthosis will be worn for 8 weeks.
|
|---|---|
|
Change in WOMAC Pain Score
|
3 units on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Medial Gonarthrosis
n=1 Participants
Patients with medial gonarthrosis
custom knee orthosis: The custom knee orthosis will be worn for 8 weeks.
|
|---|---|
|
Change in WOMAC Stiffness Score
|
1 units on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Medial Gonarthrosis
n=1 Participants
Patients with medial gonarthrosis
custom knee orthosis: The custom knee orthosis will be worn for 8 weeks.
|
|---|---|
|
Change in WOMAC Physical Function Score
|
2 units on a scale
Standard Deviation 0
|
Adverse Events
Medial Gonarthrosis
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 365 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER