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Knee Joint Effusion for Knee Injuries

N/A

Recruiting

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Tegner Activity Scale score at least 5/10

Chronological age 18-35 at the time of study participation

Must not have

Currently taking pain altering medication

History of lower extremity or lumbar spine surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately pre- (10 minutes) and post- (10 minutes) effusion

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the efficacy of a wearable sensor in detecting changes in lower extremity biomechanics due to a common clinical change in joint status.

Who is the study for?

This trial is for healthy adults aged 18-35 who are physically active, with a moderate level of engagement in sports or physical activities. Ideal candidates should not have any major knee injuries, neurological conditions, autoimmune diseases, cardiovascular issues, or be on pain medication. Pregnant individuals and those with recent lower extremity surgeries or injuries are excluded.

What is being tested?

The study aims to test the effectiveness of a wearable sensor in detecting changes in knee joint loading by artificially inducing swelling (effusion) within the knee joint. Participants will undergo tests that measure thigh and shank movement, muscle function during walking, balance, and subjective outcomes before and after this induced change.

What are the potential side effects?

Potential risks include discomfort from the experimental effusion procedure which involves introducing fluid into the knee joint under sterile conditions. The participants will be monitored for any adverse effects following the session.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My activity level is moderate or higher.

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I am between 18 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on medication to manage pain.

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I have had surgery on my lower back or legs.

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I have had a leg or lower back injury in the last 6 months.

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I have a neurological, autoimmune, or heart condition.

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I am experiencing knee pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately pre- (10 minutes) and post- (10 minutes) effusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately pre- (10 minutes) and post- (10 minutes) effusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately pre- (10 minutes) and post- (10 minutes) effusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Peak Internal Knee Extension Moment

Change in Peak Knee Power

Change in Peak Vertical Ground Reaction Force

+4 more

Secondary study objectives

Change in Hamstring EMG

Change in International Knee Documentation Committee

Change in Quadriceps EMG

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Knee Joint EffusionExperimental Treatment1 Intervention

Participants will receive a one-time injection of 60mL of sterile saline into the suprapatellar space of the dominant lower extremity. This injection will be conducted under ultrasound guidance by a board-certified orthopedic surgeon.

0 / 7Eligibility criteria met