Spring Loaded Study

Study Overview
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Brief Summary
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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 relatednto pain and function.

Detailed Description
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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.

Official Title
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Examining the Efficacy of a Tri-Compartment Unloader Knee Brace During Physical Rehabilitation in Non-Surgical Patients With Anterior Knee Pain

Conditions
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Anterior Knee Pain

Intervention / Treatment
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* Device: Tri-Compartment Unloader Brace


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Two groups. One brace (intervention) group and one no brace (control) group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Brace Group<br>50% of the participants in the study that will not be receiving a TCU brace. | |
| Experimental: Tri-Compartment Unloader Brace Group<br>50% of the participants in the study that will be receiving a TCU brace. | Device: Tri-Compartment Unloader Brace<br>* Knee brace that is designed to reduce compressive forces on all three compartments of the knee.<br>* Other names: TCU Brace;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) |  | Baseline to 3 months | 
| Change pain intensity during activities of daily living measured with a Visual Analog Scale (VAS) | Daily living activities include: walking, going up and down stairs, squatting, and sit to stand | Baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life assessed using the EQ-5D |  | Baseline to 3 months | 
| Change in physical activity levels assessed using the Lower Extremity Activity Scale (LEAS) |  | Baseline to 3 months | 
| Change in quadricep girth as a measure of quadricep strength |  | Baseline to 3 months | 
| Effusion Grade | Excess fluid in the knee graded as none, trace, mild, moderate, large | Baseline to 3 months | 
| Number of participants experiencing painful crepitus with deep knee flexion |  | Baseline to 3 months | 
| Knee range of motion | Extension and flexion (maximum degrees) | Baseline to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Brace Effectiveness