Spring Loaded Tri-Compartment Unloader Knee Brace Study

Not Applicable

Completed

• Conditions: Anterior Knee Pain
• Interventions: Device: Tri-Compartment Unloader Brace

• Registration Number: NCT05428332
• Lead Sponsor: Stanford University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-04-05
• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-23
• Status Verified: 2024-11
• Primary Completion: 2024-11-05
• Study Completion: 2024-11-05
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Anterior knee pain that worsens when the knee is flexed and bearing weight
2. Patellofemoral chondral defect(s) or patellofemoral arthritis detected with standard of care x-ray and/or MRI
3. Kellgren and Lawrence grade 0-3 of PF joint
4. Able to wear the TCU knee brace for a minimum of 3 hours per day
5. Over 18 years old, can understand written English
6. Coronal knee alignment within 7 degrees of neutral
7. Must be able to fit within an off-the-shelf knee brace size provided by Company
8. Must complete physical therapy through Stanford

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Exclusion Criteria

1. Surgical intervention definitely indicated (major mechanical symptoms/failed substantial previous conservative measures) on the affected knee within the next year
2. Use of another brace designed to unload the knee or manage knee pain during the study
3. Varus/Valgus joint alignment > 7 degrees
4. Inability to be fit properly in an off-the-shelf brace provided by the Company
5. BMI >40
6. Bilateral knee symptoms

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tri-Compartment Unloader Brace Group	Tri-Compartment Unloader Brace	50% of the participants in the study that will be receiving a TCU brace.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	Baseline; 6-weeks and 3-months post-intervention	Visual Analog Scale (VAS) is rated on a scale of 0 to 100 where 0 means no pain and 100 means severe pain.
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Baseline; 6-weeks and 3-months post-intervention	Knee Injury and Osteoarthritis Outcome Score (KOOS) is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.

Secondary Outcome Measures

Name	Time	Method
Lower Extremity Activity Scale (LEAS)	Baseline; 6-weeks and 3-months post-intervention	Lower Extremity Activity Scale (LEAS) measures daily physical activity by having patients choose from 20 options of activity levels then getting a score corresponding to that activity level.
Effusion grade	Baseline; 6-weeks and 3-months post-intervention	Checking how much fluid is around the knee. There are different grades. 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.
Knee range of motion	Baseline; 6-weeks and 3-months post-intervention	Knee range of motion is measured at 0º extension (completely straight leg) to 130º, a fully flexed leg.
Quality of life (EQ-5D)	Baseline; 6-weeks and 3-months post-intervention	Quality of life (EQ-5D) has 5 response levels where level 1 equates to no problems and level 5 equates to severe problems.
Quadricep strength (girth)	Baseline; 6-weeks and 3-months post-intervention	Using a biodex to measure quad strength.
Painful crepitus with deep knee flexion	Baseline; 6-weeks and 3-months post-intervention	Painful crepitus is when there is a sensation or noise when you move a joint.

Trial Locations

Locations (1)

Stanford Redwood City Outpatient Center; 🇺🇸 Redwood City, California, United States