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Trial Outcomes & Findings for Spring Loaded Tri-Compartment Unloader Knee Brace Study (NCT NCT05428332)

NCT ID: NCT05428332

Last Updated: 2026-01-06

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Baseline, 6-weeks, and 3-months

Results posted on

2026-01-06

Participant Flow

20 participants signed informed consent, and 14 were randomized

Participant milestones

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

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=37 Participants
0 Participants
n=56 Participants
0 Participants
n=82 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
n=37 Participants
5 Participants
n=56 Participants
11 Participants
n=82 Participants
Age, Categorical
>=65 years
2 Participants
n=37 Participants
1 Participants
n=56 Participants
3 Participants
n=82 Participants
Sex: Female, Male
Female
3 Participants
n=37 Participants
3 Participants
n=56 Participants
6 Participants
n=82 Participants
Sex: Female, Male
Male
5 Participants
n=37 Participants
3 Participants
n=56 Participants
8 Participants
n=82 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=37 Participants
0 Participants
n=56 Participants
0 Participants
n=82 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
8 Participants
n=37 Participants
6 Participants
n=56 Participants
14 Participants
n=82 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=37 Participants
0 Participants
n=56 Participants
0 Participants
n=82 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=37 Participants
0 Participants
n=56 Participants
0 Participants
n=82 Participants
Race (NIH/OMB)
Asian
5 Participants
n=37 Participants
2 Participants
n=56 Participants
7 Participants
n=82 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=37 Participants
0 Participants
n=56 Participants
0 Participants
n=82 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=37 Participants
1 Participants
n=56 Participants
1 Participants
n=82 Participants
Race (NIH/OMB)
White
3 Participants
n=37 Participants
2 Participants
n=56 Participants
5 Participants
n=82 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=37 Participants
0 Participants
n=56 Participants
0 Participants
n=82 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=37 Participants
1 Participants
n=56 Participants
1 Participants
n=82 Participants
Region of Enrollment
United States
8 Participants
n=37 Participants
6 Participants
n=56 Participants
14 Participants
n=82 Participants

PRIMARY outcome

Timeframe: Baseline, 6-weeks, and 3-months

Population: 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

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)
3 months
72.39 score on a scale
Standard Deviation 11.19
86.76 score on a scale
Standard Deviation 13.39
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

PRIMARY outcome

Timeframe: Baseline, 6-weeks, and 3-months

Population: 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

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)
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
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

SECONDARY outcome

Timeframe: Baseline, 6-weeks, and 3-months

Population: 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

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-months

Population: 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

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)
Baseline
9 score on a scale
Standard Deviation 5.66
12.3 score on a scale
Standard Deviation 5.7
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)
3 Months
14 score on a scale
Standard Deviation 3.54
11.25 score on a scale
Standard Deviation 4.57

SECONDARY outcome

Timeframe: Baseline; 6-weeks and 3-months post-intervention

Using a biodex to measure quad strength.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; 6-weeks and 3-months post-intervention

Checking how much fluid is around the knee. There are different grades. 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

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; 6-weeks and 3-months post-intervention

Painful crepitus is when there is a sensation or noise when you move a joint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; 6-weeks and 3-months post-intervention

Knee range of motion is measured at 0º extension (completely straight leg) to 130º, a fully flexed leg.

Outcome measures

Outcome data not reported

Adverse Events

Experimental: TCU Bracing

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Allen Seo

Stanford University

Phone: 9254939732

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place