Spring Loaded Study
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: No Brace Group 50% of the participants in the study that will not be receiving a TCU brace. |
|
| Experimental: Tri-Compartment Unloader Brace Group 50% of the participants in the study that will be receiving a TCU brace. |
Device: Tri-Compartment Unloader Brace
Knee brace that is designed to reduce compressive forces on all three compartments of the knee.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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) [Baseline to 3 months]
Daily living activities include: walking, going up and down stairs, squatting, and sit to stand
Secondary Outcome Measures
- 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 [Baseline to 3 months]
Excess fluid in the knee graded as none, trace, mild, moderate, large
- Number of participants experiencing painful crepitus with deep knee flexion [Baseline to 3 months]
- Knee range of motion [Baseline to 3 months]
Extension and flexion (maximum degrees)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Anterior knee pain that worsens when the knee is flexed and bearing weight
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Patellofemoral chondral defect(s) or patellofemoral arthritis detected with standard of care x-ray and/or MRI
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Kellgren and Lawrence grade 0-3 of PF joint
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Able to wear the TCU knee brace for a minimum of 3 hours per day
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Over 18 years old, can understand written English
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Coronal knee alignment within 7 degrees of neutral
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Must be able to fit within an off-the-shelf knee brace size provided by Company
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Must complete physical therapy through Stanford
Exclusion Criteria:
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Surgical intervention definitely indicated (major mechanical symptoms/failed substantial previous conservative measures) on the affected knee within the next year
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Use of another brace designed to unload the knee or manage knee pain during the study
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Varus/Valgus joint alignment > 7 degrees
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Inability to be fit properly in an off-the-shelf brace provided by the Company
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BMI >40
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Bilateral knee symptoms
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford Redwood City Outpatient Center | Redwood City | California | United States | 94063 |
Sponsors and Collaborators
- Stanford University
- Spring Loaded Tech
Investigators
- Principal Investigator: Seth L Sherman, MD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 62059