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Knee InjuriesNCT03805464

Walking Gait Biomechanics Following Knee Joint Effusion

A study testing Knee Joint Effusion in people with Knee Injuries and Knee Osteoarthritis, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Knee Injuries, Knee Osteoarthritis
What is being tested?
Knee Joint Effusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
29 Jan 2019to 18 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 10Show fewer
  • Currently taking pain altering medication.
  • Fear of needles
  • Unable to read and understand English language
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Michael W. Krzyzewski Human Performance Laboratory

    Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: 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.

Being tested
Knee Joint Effusion
Keywords
biomechanics, inertial measurement unit
Medical subject headings
Knee Injuries, Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Knee Joint EffusionOther

    60mL saline injection into the supra-patellar region of the knee

Study groups in NCT03805464
Study groupRoleWhat they receive
Knee Joint EffusionExperimentalParticipants 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.
Receives: Other: Knee Joint Effusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Peak Vertical Ground Reaction Force

    Kinetic Loading Variable

    Measured: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

  2. Change in Peak Internal Knee Extension Moment

    Kinetic Loading Variable

    Measured: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

  3. Change in Peak Knee Power

    Kinetic Loading Variable

    Measured: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

  4. Change in Shank Acceleration

    Accelerometer Variable

    Measured: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

  5. Change in Thigh Acceleration

    Accelerometer Variable

    Measured: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

  6. Change in Shank Angular Velocity

    Gyroscope Variable

    Measured: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

  7. Change in Thigh Angular Velocity

    Gyroscope Variable

    Measured: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Secondary outcomes (4)

  1. Change in Quadriceps EMG

    Muscle Activity Variable

    Measured: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

  2. Change in Hamstring EMG

    Muscle Activity Variable

    Measured: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

  3. Change in Visual Analog Scale Pain

    Pain Variable

    Measured: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

  4. Change in International Knee Documentation Committee

    Self-Reported Disability Variable

    Measured: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2019
  2. Study start29 Jan 2019
  3. Primary completion18 May 2023
  4. Study completion18 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03805464
Sponsor's protocol ID
Pro00100862
Status last verified
Feb 2025
First submitted
11 Jan 2019
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Knee Joint Effusion in people with Knee Injuries and Knee Osteoarthritis, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Peak Vertical Ground Reaction Force (time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03805464.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.

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