Walking Gait Biomechanics Following Knee Joint Effusion

• Sponsor: Duke University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03805464
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 46.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Injuries; Knee Osteoarthritis	Other: Knee Joint Effusion	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Characterizing Changes in Knee Joint Loading With Wearable Sensor Technology Following an Experimental Knee Joint Effusion
• Actual Study Start Date: Jan 29, 2019
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Peak Vertical Ground Reaction Force [Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion]

   Kinetic Loading Variable

2. Change in Peak Internal Knee Extension Moment [Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion]

   Kinetic Loading Variable

3. Change in Peak Knee Power [Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion]

   Kinetic Loading Variable

4. Change in Shank Acceleration [Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion]

   Accelerometer Variable

5. Change in Thigh Acceleration [Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion]

   Accelerometer Variable

6. Change in Shank Angular Velocity [Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion]

   Gyroscope Variable

7. Change in Thigh Angular Velocity [Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion]

   Gyroscope Variable

Secondary Outcome Measures

1. Change in Quadriceps EMG [Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion]

   Muscle Activity Variable

2. Change in Hamstring EMG [Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion]

   Muscle Activity Variable

3. Change in Visual Analog Scale Pain [Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion]

   Pain Variable

4. Change in International Knee Documentation Committee [Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion]

   Self-Reported Disability Variable

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Michael W. Krzyzewski Human Performance Laboratory	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• Duke University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03805464
• Other Study ID Numbers: Pro00100862
• First Posted: Jan 15, 2019
• Last Update Posted: May 6, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Duke University: biomechanics; inertial measurement unit
• Additional relevant MeSH terms: Osteoarthritis, Knee; Hydrarthrosis; Knee Injuries

Study Results

No Results Posted as of May 6, 2022