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Knee Brace for Knee Pain

N/A
Recruiting
Led By Seth L Sherman, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patellofemoral chondral defect(s) or patellofemoral arthritis detected with standard of care x-ray and/or MRI
Over 18 years old, can understand written English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; 6-weeks and 3-months post-intervention
Awards & highlights

Study Summary

This trial will study whether a Tri-Compartment Unloader knee brace improves clinical outcomes for patients with anterior knee pain during activities of daily living, when compared to standard care without the brace.

Who is the study for?
The Spring Loaded Study is for adults over 18 with anterior knee pain due to cartilage defects or arthritis, who can wear a special knee brace for at least 3 hours daily and complete physical therapy at Stanford. Participants should have mild to moderate disease severity, be able to read English, fit in a standard brace size, and not need surgery within the year. Those with severe joint misalignment or extreme obesity (BMI >40) are excluded.Check my eligibility
What is being tested?
This trial tests if wearing a Tri-Compartment Unloader Brace improves pain and function in patients with anterior knee pain during daily activities compared to standard non-surgical care alone. The TCU brace aims to lessen pressure in all three compartments of the knee when it's bent under weight.See study design
What are the potential side effects?
Potential side effects from using the TCU brace may include skin irritation where the brace contacts the body, discomfort or increased pain if improperly fitted, restricted movement leading possibly to muscle weakness or stiffness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have knee cartilage damage or arthritis confirmed by an x-ray or MRI.
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I am over 18 and can understand written English.
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My knee hurts more when I bend it and put weight on it.
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I can wear the TCU knee brace for at least 3 hours daily.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; 6-weeks and 3-months post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; 6-weeks and 3-months post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Visual Analog Scale (VAS)
Secondary outcome measures
Effusion grade
Knee range of motion
Lower Extremity Activity Scale (LEAS)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tri-Compartment Unloader Brace GroupExperimental Treatment1 Intervention
50% of the participants in the study that will be receiving a TCU brace.
Group II: No Brace GroupActive Control1 Intervention
50% of the participants in the study that will not be receiving a TCU brace.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,330 Total Patients Enrolled
Spring Loaded TechUNKNOWN
Seth L Sherman, MDPrincipal InvestigatorStanford University
3 Previous Clinical Trials
56 Total Patients Enrolled

Media Library

Tri-Compartment Unloader Brace Clinical Trial Eligibility Overview. Trial Name: NCT05428332 — N/A
Anterior Knee Pain Research Study Groups: No Brace Group, Tri-Compartment Unloader Brace Group
Anterior Knee Pain Clinical Trial 2023: Tri-Compartment Unloader Brace Highlights & Side Effects. Trial Name: NCT05428332 — N/A
Tri-Compartment Unloader Brace 2023 Treatment Timeline for Medical Study. Trial Name: NCT05428332 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the estimated participant count of this research endeavor?

"Affirmative. According to information hosted on clinicaltrials.gov, this medical trial has been actively recruiting patients since April 5th 2022 and the most recent edit was made on June 16th 2022. This experiment requires 20 participants from a single site for completion."

Answered by AI

Who else is applying?

What site did they apply to?
Stanford Redwood City Outpatient Center
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I would like to continue playing sports, specifically basketball, while minimizing continued osteoarthritic degeneration in my knee. Currently vigorous activity like basketball leads to swelling.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Spring Loaded Tri-Compartment Unloader Knee Brace Study
Seth Sherman 2022. "Spring Loaded Tri-Compartment Unloader Knee Brace Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05428332.
~4 spots leftby Nov 2024
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