Spring Loaded Tri-Compartment Unloader Knee Brace Study

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

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.

Study Overview

• Status: Completed
• Conditions: Anterior Knee Pain
• Intervention / Treatment: Device: Tri-Compartment Unloader Brace

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Stanford Redwood City Outpatient Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: TCU Brace

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Knee Injury and Osteoarthritis Outcome Score (KOOS) patient-reported outcome questionnaire; responses are scaled to a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.	Baseline, 6-weeks, and 3-months
Pain Visual Analog Scale (VAS)	Visual Analog Scale (VAS) is rated on a scale of 0 to 100 where 0 means no pain and 100 means severe pain.	Baseline, 6-weeks, and 3-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life (EQ-5D)	Quality of life (EQ-5D) has 5 response levels where level 1 equates to no problems and level 5 equates to severe problems. The EQ-5D assesses quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The responses are then scaled to a score of 0 to 100 (high scores correspond to higher health related quality of life).	Baseline, 6-weeks, and 3-months
Lower Extremity Activity Scale (LEAS)	Lower Extremity Activity Scale (LEAS) measures daily physical activity by having patients answer 20 questions, choosing from 18 options of activity levels (0 = no activity, to 18 = college/professional athlete level of activity). Individual scores are summed and averaged to create the overall score (range: 0 to 18, with highest scores corresponding to highest level of activity).	Baseline, 6-weeks, and 3-months
Quadricep Strength (Girth)	Using a biodex to measure quadriceps strength. Number of participants achieving a minimal clinically important difference (MCID) in quadriceps strength, defined as a greater than or equal to 10% increase from baseline.	Baseline through 3-months post-intervention
Effusion Grade	Number of participants with effusion, by grade. Checking how much fluid is around the knee. There are different grades, ranging from Grade 1 to Grade 5. 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.	Baseline through 3-months post-intervention
Painful Crepitus With Deep Knee Flexion	Number of participants with painful crepitus at deep knee flexion, which is when there is a sensation or noise when you move a joint.	Baseline through 3 months post-intervention
Knee Range of Motion	Number of participants with full or deficient range of motion (ROM). Knee range of motion is measured at 0º extension (completely straight leg) to 130º, a fully flexed leg. Deficient ROM is nonzero at full extension and/or < 130° flexion. Full ROM is defined as 0° extension and 130° flexion.	Baseline through 3 months post-intervention

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Spring Loaded Tech
• Investigators: Principal Investigator: Seth L Sherman, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2022
• Primary Completion (Actual): November 5, 2024
• Study Completion (Actual): November 5, 2024

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Knee Brace Effectiveness
• Other Study ID Numbers: 62059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No