N/A
N=14
Spring Loaded Tri-Compartment Unloader Knee Brace Study
Anterior Knee Pain
Bottom Line
View on ClinicalTrials.gov: NCT05428332 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Knee Injury and Osteoarthritis Outcome Score (KOOS) — 61.91; 72.59; 71.17; 85.99 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tri-Compartment Unloader Brace (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knee Injury and Osteoarthritis Outcome Score (KOOS) |
61.91; 72.59; 71.17; 85.99; 72.39; 86.76 | — |
| PRIMARY Pain Visual Analog Scale (VAS) |
20; 36.17; 12.61; 8.42; 12.33; 15.5 | — |
| SECONDARY Quality of Life (EQ-5D) |
67.5; 79.8; 74.83; 71.0; 85.8; 69.0 | — |
| SECONDARY Lower Extremity Activity Scale (LEAS) |
9; 12.3; 13; 12; 14; 11.25 | — |
| SECONDARY Quadricep Strength (Girth) |
0; 1; 8; 5 | — |
| SECONDARY Effusion Grade |
7; 5; 1; 1 | — |
| SECONDARY Painful Crepitus With Deep Knee Flexion |
3; 5; 5; 1 | — |
| SECONDARY Knee Range of Motion |
3; 2; 5; 4 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Anterior knee pain that worsens when the knee is flexed and bearing weight
- Patellofemoral chondral defect(s) or patellofemoral arthritis detected with standard of care x-ray and/or MRI
- Kellgren and Lawrence grade 0-3 of PF joint
- Able to wear the TCU knee brace for a minimum of 3 hours per day
- Over 18 years old, can understand written English
- Coronal knee alignment within 7 degrees of neutral
- Must be able to fit within an off-the-shelf knee brace size provided by Company
- Must complete physical therapy through Stanford
Exclusion Criteria
- Surgical intervention definitely indicated (major mechanical symptoms/failed substantial previous conservative measures) on the affected knee within the next year
- Use of another brace designed to unload the knee or manage knee pain during the study
- Varus/Valgus joint alignment > 7 degrees
- Inability to be fit properly in an off-the-shelf brace provided by the Company
- BMI >40
- Bilateral knee symptoms
Data sourced from ClinicalTrials.gov (NCT05428332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.