Spring Loaded Tri-Compartment Unloader Knee Brace Study

Anterior Knee Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05428332
• Other study ID #: 62059
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2022
• Est. completion date: December 5, 2024

Study information

• Verified date: March 2024
• Source: Stanford University
• Contact: Monica S Vel, BS
• Phone: (650) 721-7653
• Email: msvel[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 5, 2024
• Est. primary completion date: November 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Knee Pain

Intervention

Device:
• Tri-Compartment Unloader Brace
Knee brace that is designed to reduce compressive forces on all three compartments of the knee.

Locations

Country	Name	City	State
United States	Stanford Redwood City Outpatient Center	Redwood City	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Spring Loaded Tech

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Injury and Osteoarthritis Outcome Score (KOOS)	Knee Injury and Osteoarthritis Outcome Score (KOOS) is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.	Baseline; 6-weeks and 3-months post-intervention
Primary	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 post-intervention
Secondary	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.	Baseline; 6-weeks and 3-months post-intervention
Secondary	Lower Extremity Activity Scale (LEAS)	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.	Baseline; 6-weeks and 3-months post-intervention
Secondary	Quadricep strength (girth)	Using a biodex to measure quad strength.	Baseline; 6-weeks and 3-months post-intervention
Secondary	Effusion grade	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.	Baseline; 6-weeks and 3-months post-intervention
Secondary	Painful crepitus with deep knee flexion	Painful crepitus is when there is a sensation or noise when you move a joint.	Baseline; 6-weeks and 3-months post-intervention
Secondary	Knee range of motion	Knee range of motion is measured at 0º extension (completely straight leg) to 130º, a fully flexed leg.	Baseline; 6-weeks and 3-months post-intervention