Walking Gait Biomechanics Following Knee Joint Effusion

Characterizing Changes in Knee Joint Loading With Wearable Sensor Technology Following an Experimental Knee Joint Effusion

The purpose of this study is to determine the sensitivity of a wearable sensor to detect changes in knee joint loading using an experimental knee joint effusion as a model for a common clinical physiological alteration in joint status. The rationale for this project is that it will establish the efficacy of an inexpensive, clinically, and publicly available device that can detect changes in biomechanical loading due to acute physiologic change in joint status. The study will utilize a cross-sectional cohort study design and will seek to enroll 25 male and female healthy adult participants (18-35 yo). Participants will report to the laboratory for three total sessions (Session 1: informed consent and task familiarization; Session 2: testing; Session 3: knee joint status assessment). The primary outcomes of interest include lower extremity thigh and shank acceleration and velocity data (wearable sensor data), lower extermity 3D kinematics and kinetics (motion capture data), and lower extremity muscle function (EMG data) during walking gait, as well as functional balance and patient-reported subjective outcomes. Data will be analyzed by calculating change scores from the pre- to post-experimental effusion outcome measure testing. Paired-samples t-tests and Cohen's d effect sizes will be used to assess changed in wearable sensor data from pre- to post-experimental effusion. Correlation statistics will be used to determine if there are association between the motion capture and wearable sensor data. The potential risks associated with an experimental joint effusion will be addressed by maintaining appropriate sterile conditions and having the participant check-in with the PI (licensed healthcare provider) at 48 hours following testing session.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Knee Injuries
• Intervention / Treatment: Other: Knee Joint Effusion

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Michael W. Krzyzewski Human Performance Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male and female
• Chronological age 18-35 at the time of study participation
• Physically active (at least 30 minutes of physical activity, 3x/week)
• Tegner Activity Scale score at least 5/10

Exclusion Criteria:

• History of lower extremity or lumbar spine surgery.
• History of lower extremity or lumbar spine injury in the prior 6 months.
• History of major ligamentous damage.
• Current knee pain.
• Known neurological condition, autoimmune condition, cardiovascular disease.
• History of epilepsy, seizures, concussion within the prior 6 months.
• Currently taking pain altering medication.
• Fear of needles
• Unable to read and understand English language
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Knee Joint Effusion; 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.	Other: Knee Joint Effusion; 60mL saline injection into the supra-patellar region of the knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Peak Vertical Ground Reaction Force	Kinetic Loading Variable	Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Change in Peak Internal Knee Extension Moment	Kinetic Loading Variable	Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Change in Peak Knee Power	Kinetic Loading Variable	Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Change in Shank Acceleration	Accelerometer Variable	Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Change in Thigh Acceleration	Accelerometer Variable	Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Change in Shank Angular Velocity	Gyroscope Variable	Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Change in Thigh Angular Velocity	Gyroscope Variable	Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quadriceps EMG	Muscle Activity Variable	Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Change in Hamstring EMG	Muscle Activity Variable	Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Change in Visual Analog Scale Pain	Pain Variable	Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Change in International Knee Documentation Committee	Self-Reported Disability Variable	Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2019
• Primary Completion (Actual): May 18, 2023
• Study Completion (Actual): May 18, 2023

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: biomechanics; inertial measurement unit
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Arthritis; Joint Diseases; Rheumatic Diseases; Leg Injuries; Osteoarthritis; Osteoarthritis, Knee; Knee Injuries
• Other Study ID Numbers: Pro00100862

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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