Trial Outcomes & Findings for Spring Loaded Tri-Compartment Unloader Knee Brace Study (NCT NCT05428332)
NCT ID: NCT05428332
Last Updated: 2026-05-05
Results Overview
Knee Injury and Osteoarthritis Outcome Score (KOOS) patient-reported outcome questionnaire; responses are scaled to a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
COMPLETED
NA
20 participants
Baseline, 6-weeks, and 3-months
2026-05-05
Participant Flow
20 participants signed informed consent, and 14 were randomized
Participant milestones
| Measure |
Experimental: TCU Bracing
Participants will be instructed to wear a tricompartment offloader (TCU) knee brace (Levitation 2) for a minimum of 3 hours per day during activities of daily living and undergo standard of care rehabilitation protocol.
|
Control
Participants will undergo standard of care rehabilitation protocol only.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
|
Overall Study
COMPLETED
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Spring Loaded Tri-Compartment Unloader Knee Brace Study
Baseline characteristics by cohort
| Measure |
Experimental: TCU Bracing
n=8 Participants
Participants will be instructed to wear a TCU knee brace (Levitation 2) for a minimum of 3 hours per day during activities of daily living and undergo standard of care rehabilitation protocol.
|
Control
n=6 Participants
Participants will undergo standard of care rehabilitation protocol only.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=54 Participants
|
5 Participants
n=60 Participants
|
11 Participants
n=114 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
3 Participants
n=114 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
6 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
8 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
14 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
7 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
5 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
14 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6-weeks, and 3-monthsPopulation: Participants with available data at the respective time point
Knee Injury and Osteoarthritis Outcome Score (KOOS) patient-reported outcome questionnaire; responses are scaled to a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Outcome measures
| Measure |
Experimental: TCU Bracing
n=8 Participants
Participants will be instructed to wear a TCU knee brace (Levitation 2) for a minimum of 3 hours per day during activities of daily living and undergo standard of care rehabilitation protocol.
|
Control
n=6 Participants
Participants will undergo standard of care rehabilitation protocol only.
|
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Baseline
|
61.91 score on a scale
Standard Deviation 14.42
|
72.59 score on a scale
Standard Deviation 15.72
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
6 weeks
|
71.17 score on a scale
Standard Deviation 8.87
|
85.99 score on a scale
Standard Deviation 16.60
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
3 months
|
72.39 score on a scale
Standard Deviation 11.19
|
86.76 score on a scale
Standard Deviation 13.39
|
PRIMARY outcome
Timeframe: Baseline, 6-weeks, and 3-monthsPopulation: Participants with available data at the respective time point
Visual Analog Scale (VAS) is rated on a scale of 0 to 100 where 0 means no pain and 100 means severe pain.
Outcome measures
| Measure |
Experimental: TCU Bracing
n=8 Participants
Participants will be instructed to wear a TCU knee brace (Levitation 2) for a minimum of 3 hours per day during activities of daily living and undergo standard of care rehabilitation protocol.
|
Control
n=6 Participants
Participants will undergo standard of care rehabilitation protocol only.
|
|---|---|---|
|
Pain Visual Analog Scale (VAS)
3 months
|
12.33 score on a scale
Standard Deviation 9.71
|
15.5 score on a scale
Standard Deviation 17.92
|
|
Pain Visual Analog Scale (VAS)
Baseline
|
20 score on a scale
Standard Deviation 0
|
36.17 score on a scale
Standard Deviation 23.37
|
|
Pain Visual Analog Scale (VAS)
6 weeks
|
12.61 score on a scale
Standard Deviation 7.52
|
8.42 score on a scale
Standard Deviation 10.48
|
SECONDARY outcome
Timeframe: Baseline, 6-weeks, and 3-monthsPopulation: Participants with available data at the respective time point
Quality of life (EQ-5D) has 5 response levels where level 1 equates to no problems and level 5 equates to severe problems. The EQ-5D assesses quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The responses are then scaled to a score of 0 to 100 (high scores correspond to higher health related quality of life).
Outcome measures
| Measure |
Experimental: TCU Bracing
n=8 Participants
Participants will be instructed to wear a TCU knee brace (Levitation 2) for a minimum of 3 hours per day during activities of daily living and undergo standard of care rehabilitation protocol.
|
Control
n=6 Participants
Participants will undergo standard of care rehabilitation protocol only.
|
|---|---|---|
|
Quality of Life (EQ-5D)
Baseline
|
67.5 score on a scale
Standard Deviation 3.54
|
79.8 score on a scale
Standard Deviation 12.76
|
|
Quality of Life (EQ-5D)
6 Weeks
|
74.83 score on a scale
Standard Deviation 14.32
|
71.0 score on a scale
Standard Deviation 32.99
|
|
Quality of Life (EQ-5D)
3 Months
|
85.8 score on a scale
Standard Deviation 12.89
|
69.0 score on a scale
Standard Deviation 26.80
|
SECONDARY outcome
Timeframe: Baseline, 6-weeks, and 3-monthsPopulation: Participants with available data at the respective time point
Lower Extremity Activity Scale (LEAS) measures daily physical activity by having patients answer 20 questions, choosing from 18 options of activity levels (0 = no activity, to 18 = college/professional athlete level of activity). Individual scores are summed and averaged to create the overall score (range: 0 to 18, with highest scores corresponding to highest level of activity).
Outcome measures
| Measure |
Experimental: TCU Bracing
n=8 Participants
Participants will be instructed to wear a TCU knee brace (Levitation 2) for a minimum of 3 hours per day during activities of daily living and undergo standard of care rehabilitation protocol.
|
Control
n=6 Participants
Participants will undergo standard of care rehabilitation protocol only.
|
|---|---|---|
|
Lower Extremity Activity Scale (LEAS)
3 Months
|
14 score on a scale
Standard Deviation 3.54
|
11.25 score on a scale
Standard Deviation 4.57
|
|
Lower Extremity Activity Scale (LEAS)
6 Weeks
|
13 score on a scale
Standard Deviation 4.2
|
12 score on a scale
Standard Deviation 4.5
|
|
Lower Extremity Activity Scale (LEAS)
Baseline
|
9 score on a scale
Standard Deviation 5.66
|
12.3 score on a scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Baseline through 3-months post-interventionUsing a biodex to measure quadriceps strength. Number of participants achieving a minimal clinically important difference (MCID) in quadriceps strength, defined as a greater than or equal to 10% increase from baseline.
Outcome measures
| Measure |
Experimental: TCU Bracing
n=8 Participants
Participants will be instructed to wear a TCU knee brace (Levitation 2) for a minimum of 3 hours per day during activities of daily living and undergo standard of care rehabilitation protocol.
|
Control
n=6 Participants
Participants will undergo standard of care rehabilitation protocol only.
|
|---|---|---|
|
Quadricep Strength (Girth)
Achieved MCID
|
0 Participants
|
1 Participants
|
|
Quadricep Strength (Girth)
Did Not Achieve MCID
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline through 3-months post-interventionNumber of participants with effusion, by grade. Checking how much fluid is around the knee. There are different grades, ranging from Grade 1 to Grade 5. Grade 1 means no fluid-wave while performing a downward stroke whereas Grade 5 means excess of fluid that makes it impossible to stroke the medial fluid away.
Outcome measures
| Measure |
Experimental: TCU Bracing
n=8 Participants
Participants will be instructed to wear a TCU knee brace (Levitation 2) for a minimum of 3 hours per day during activities of daily living and undergo standard of care rehabilitation protocol.
|
Control
n=6 Participants
Participants will undergo standard of care rehabilitation protocol only.
|
|---|---|---|
|
Effusion Grade
No Clinically Significant Effusion (Grade 1)
|
7 Participants
|
5 Participants
|
|
Effusion Grade
Presence of Effusion (Grades 2-5)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline through 3 months post-interventionNumber of participants with painful crepitus at deep knee flexion, which is when there is a sensation or noise when you move a joint.
Outcome measures
| Measure |
Experimental: TCU Bracing
n=8 Participants
Participants will be instructed to wear a TCU knee brace (Levitation 2) for a minimum of 3 hours per day during activities of daily living and undergo standard of care rehabilitation protocol.
|
Control
n=6 Participants
Participants will undergo standard of care rehabilitation protocol only.
|
|---|---|---|
|
Painful Crepitus With Deep Knee Flexion
No crepitus
|
3 Participants
|
5 Participants
|
|
Painful Crepitus With Deep Knee Flexion
Crepitus
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline through 3 months post-interventionNumber of participants with full or deficient range of motion (ROM). Knee range of motion is measured at 0º extension (completely straight leg) to 130º, a fully flexed leg. Deficient ROM is nonzero at full extension and/or \< 130° flexion. Full ROM is defined as 0° extension and 130° flexion.
Outcome measures
| Measure |
Experimental: TCU Bracing
n=8 Participants
Participants will be instructed to wear a TCU knee brace (Levitation 2) for a minimum of 3 hours per day during activities of daily living and undergo standard of care rehabilitation protocol.
|
Control
n=6 Participants
Participants will undergo standard of care rehabilitation protocol only.
|
|---|---|---|
|
Knee Range of Motion
Achieved Full ROM
|
3 Participants
|
2 Participants
|
|
Knee Range of Motion
Deficient ROM
|
5 Participants
|
4 Participants
|
Adverse Events
Experimental: TCU Bracing
Control
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
- Publication restrictions are in place