Status:
COMPLETED
Spring Loaded Tri-Compartment Unloader Knee Brace Study
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Spring Loaded Tech
Conditions:
Anterior Knee Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05428332
Start Date
April 5 2022
End Date
November 5 2024
Last Update
January 6 2026
Active Locations (1)
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1
Stanford Redwood City Outpatient Center
Redwood City, California, United States, 94063