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| Name | Class |
|---|---|
| Spring Loaded Tech | UNKNOWN |
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This study will examine clinical outcomes related to pain and function in patients with anterior knee pain (i.e. focal patella and/or trochlea cartilage defect(s), patellofemoral arthritis) before and after standard of care, non-surgical management with and without the addition of a Tri-Compartment Unloader (TCU) knee brace during activities of daily living. Randomly selected participants will wear a TCU brace for several weeks during physical therapy and activities of daily living that is designed to reduce compressive forces in all three compartments of the knee during weight-bearing flexion. Our hypothesis is that TCU bracing will improve clinical outcomes related to pain and function.
Patients in this study have been identified as good candidates by their physicians. As the study procedures closely follow the standard of care procedures in place, study participation presents little additional risk above and beyond the standard of care procedures. The study was designed to present the least risk possible consistent with sound research design.
Participants in this study will undergo standard of care X-rays that will help in eligibility determination. Participants will be randomized to either group, and will have a 50% chance of receiving the brace. Outcomes will be measured at baseline (before any intervention), 6 weeks after commencing rehabilitation at Stanford, and 3 months after commencing rehabilitation at Stanford.
These outcome measures are collected using PatientiQ which is is being used at the clinic as part of standard of care. Spring Loaded Tech is providing the TCU braces for the patients in this study at no cost.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Brace Group | No Intervention | 50% of the participants in the study that will not be receiving a TCU brace. | |
| Tri-Compartment Unloader Brace Group | Experimental | 50% of the participants in the study that will be receiving a TCU brace. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tri-Compartment Unloader Brace | Device | Knee brace that is designed to reduce compressive forces on all three compartments of the knee. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | 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. | Baseline, 6-weeks, and 3-months |
| Pain Visual Analog Scale (VAS) | Visual Analog Scale (VAS) is rated on a scale of 0 to 100 where 0 means no pain and 100 means severe pain. | Baseline, 6-weeks, and 3-months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (EQ-5D) | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seth L Sherman, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Redwood City Outpatient Center | Redwood City | California | 94063 | United States |
There is no plan to share data.
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20 participants signed informed consent, and 14 were randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control | Participants will undergo standard of care rehabilitation protocol only. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: TCU Bracing | 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. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Knee Injury and Osteoarthritis Outcome Score (KOOS) | 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. | Participants with available data at the respective time point | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6-weeks, and 3-months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental: TCU Bracing | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allen Seo | Stanford University | 9254939732 | allenseo@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 28, 2022 | Sep 26, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 28, 2022 | Oct 10, 2025 | SAP_001.pdf |
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Two groups. One brace (intervention) group and one no brace (control) group.
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No one will be masked/blinded in this study.
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|
| Baseline, 6-weeks, and 3-months |
| Lower Extremity Activity Scale (LEAS) | 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). | Baseline, 6-weeks, and 3-months |
| Quadricep Strength (Girth) | Using 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. | Baseline through 3-months post-intervention |
| Effusion Grade | Number 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. | Baseline through 3-months post-intervention |
| Painful Crepitus With Deep Knee Flexion | Number of participants with painful crepitus at deep knee flexion, which is when there is a sensation or noise when you move a joint. | Baseline through 3 months post-intervention |
| Knee Range of Motion | Number 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. | Baseline through 3 months post-intervention |
Participants will undergo standard of care rehabilitation protocol only. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Participants will undergo standard of care rehabilitation protocol only.
|
|
| Primary | Pain Visual Analog Scale (VAS) | Visual Analog Scale (VAS) is rated on a scale of 0 to 100 where 0 means no pain and 100 means severe pain. | Participants with available data at the respective time point | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6-weeks, and 3-months |
|
|
|
| Secondary | Quality of Life (EQ-5D) | 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). | Participants with available data at the respective time point | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6-weeks, and 3-months |
|
|
|
| Secondary | Lower Extremity Activity Scale (LEAS) | 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). | Participants with available data at the respective time point | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6-weeks, and 3-months |
|
|
|
| Secondary | Quadricep Strength (Girth) | Using 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. | Posted | Count of Participants | Participants | Baseline through 3-months post-intervention |
|
|
|
| Secondary | Effusion Grade | Number 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. | Posted | Count of Participants | Participants | Baseline through 3-months post-intervention |
|
|
|
| Secondary | Painful Crepitus With Deep Knee Flexion | Number of participants with painful crepitus at deep knee flexion, which is when there is a sensation or noise when you move a joint. | Posted | Count of Participants | Participants | Baseline through 3 months post-intervention |
|
|
|
| Secondary | Knee Range of Motion | Number 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. | Posted | Count of Participants | Participants | Baseline through 3 months post-intervention |
|
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Control | Participants will undergo standard of care rehabilitation protocol only. | 0 | 6 | 0 | 6 | 0 | 6 |
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| 6 weeks |
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| 3 months |
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| 6 Weeks |
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| 3 Months |
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| 6 Weeks |
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| 3 Months |
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