Knee Joint Effusion for Knee Injuries

Overseen By Laura S Pietrosimone, PT, DPT, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must not be taking: Pain medications

Disqualifiers: Surgery, Injury, Neurological, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

25 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are currently taking pain-altering medication, you cannot participate in this trial.

What data supports the effectiveness of the treatment Knee Joint Effusion for knee injuries?

The research suggests that knee joint effusion, when detected, can indicate underlying soft tissue injury, and managing it through aspiration (removing fluid) is a common approach, although its benefits are not yet confirmed by strong studies. Additionally, early intervention in knee effusion can help in managing conditions like knee osteoarthritis. ^{1 2 3 4 5}

Is Knee Joint Effusion treatment generally safe for humans?

The research articles provided do not contain specific safety data for Knee Joint Effusion treatment for knee injuries. However, they discuss adverse events related to biological therapies and surgical interventions, which may offer some context on the importance of monitoring safety in medical treatments. ^{6 7 8 9 10}

How does this treatment for knee joint effusion differ from other treatments?

The treatment for knee joint effusion in this trial may involve a unique approach such as joint aspiration, which is a procedure to remove excess fluid from the knee joint. This method is different from other treatments as it directly addresses the fluid buildup, although its effectiveness compared to other methods has not been conclusively proven in randomized studies. ^{1 2 4 5 11}

Eligibility Criteria

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.

Inclusion Criteria

My activity level is moderate or higher.

Physically active (at least 30 minutes of physical activity, 3x/week)

I am between 18 and 35 years old.

Exclusion Criteria

Pregnancy

History of major ligamentous damage

Fear of needles

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Task Familiarization

Participants undergo informed consent and task familiarization

1 session

1 visit (in-person)

Testing

Participants receive a one-time injection of 60mL of sterile saline into the suprapatellar space and undergo testing

1 session

1 visit (in-person)

Knee Joint Status Assessment

Assessment of knee joint status post-experimental effusion

1 session

1 visit (in-person)

Follow-up

Participants check-in with the PI for safety monitoring 48 hours after testing

2 days

1 visit (in-person)

Treatment Details

Interventions

• Knee Joint Effusion

Trial Overview 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.

Participant Groups

Group I: Knee Joint Effusion Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

Post-traumatic knee effusion is typically easy to diagnose, often presenting as bloody, but requires careful differential diagnosis to identify serious soft-tissue and bone injuries.

Diagnostic tools such as special X-rays, arthroscopy, and arthrography are essential for accurate assessment, and immediate unloading of the joint is crucial to prevent further damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Differential diagnosis of post-traumatic hydrarthrosis of the knee joint]. Heusgen, J., Ludolph, E.[2018]

In a study of 100 patients with knee joint effusions after acute injury, 20% required further investigation, indicating that effusions can signal potential underlying issues.

11% of the patients ultimately needed surgery for significant soft tissue injuries, suggesting that radiologically detected effusions are important markers for assessing injury severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prognostic significance of radiologically detected knee joint effusions in the absence of associated fracture. Maskell, TW., Finlay, DB.[2016]

In a study of 404 participants over 3 years, knee effusion was found to be a significant indicator of progression from early knee osteoarthritis (OA) to radiographic OA, with a higher risk associated with larger effusion areas.

Factors such as being female, having early knee OA, and being overweight also increased the likelihood of OA progression, highlighting the importance of monitoring knee effusion in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effusion detected by ultrasonography and overweight may predict the risk of knee osteoarthritis in females with early knee osteoarthritis: a retrospective analysis of Iwaki cohort data. Ishibashi, K., Sasaki, E., Chiba, D., et al.[2022]

In a study of 167 patients with acute knee effusion, joint aspiration provided temporary improvement in pain relief and range of motion, particularly in cases of post-traumatic effusion, but this effect lasted only for the first week due to re-accumulation of fluid.

While aspiration helped in diagnosing non-traumatic effusions, it did not show significant long-term benefits compared to no aspiration for either traumatic or non-traumatic cases, suggesting it should be used cautiously, especially in trauma situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of aspiration in knee joint effusion management: a prospective randomized controlled study. Paschos, NK., Giotis, D., Abuhemoud, K., et al.[2021]

Knee joint injuries account for about 10% of casualty surgery cases and 30% of all sports injuries, highlighting their prevalence and impact on healthcare resources.

Emergency arthroscopy is recommended for post-traumatic knee joint effusion, with primary treatment ideally occurring within two to three days after the injury, followed by rehabilitation to maintain muscle strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Capsule-ligament lesions of the knee joint. Early diagnosis, primary therapy, results]. Franke, K.[2016]

The DANBIO database captured 20 times more adverse events related to biological agents than the Danish Medicines Agency, highlighting its effectiveness in monitoring patient safety.

Infections and hypersensitivity reactions were the most common adverse events, with older age, longer disease duration, and a higher number of previous DMARD treatments identified as risk factors for bacterial infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Routine database registration of biological therapy increases the reporting of adverse events twentyfold in clinical practice. First results from the Danish Database (DANBIO). Hetland, ML., Unkerskov, J., Ravn, T., et al.[2019]

In a study of 260 patients undergoing total knee arthroplasty, 21% experienced adverse events, with 6% suffering from serious adverse events, highlighting the importance of monitoring complications in surgical procedures.

The use of a standardized reporting format improved the identification of adverse events, suggesting that trained paramedical staff could enhance the documentation and management of these events in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in total knee arthroplasty: Results of a physician independent survey in 260 patients. Kirschner, S., Lützner, J., Günther, KP., et al.[2021]

The study analyzed the safety profiles of antirheumatic agents, specifically TNF inhibitors, IL-6 inhibitors, and methotrexate, using the Japanese Adverse Drug Event Report database, revealing increased risks for serious adverse events like tuberculosis and malignant tumors associated with these drugs.

Different antirheumatic agents showed varying time-to-onset for serious adverse events, with TNF inhibitors having a median onset of 501 days for tuberculosis, while methotrexate had a longer median onset of 537 days, indicating the need for tailored monitoring strategies in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Serious Adverse Event Profiles Among Antirheumatic Agents Using Japanese Adverse Drug Event Report Database. Matsuoka, Y., Narukawa, M.[2020]

A study analyzing adverse events (AEs) from TNFα inhibitors (adalimumab, infliximab, etanercept) in South Korea identified 5594 AEs, revealing seven new signals not previously listed on drug labels, including medication errors and thyroid neoplasm malignant.

Specific AEs were found to be significantly more likely in patients using these drugs, such as injection site pain for adalimumab and uveitis for etanercept, highlighting the need for updated drug labels to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of signal detection of tumour necrosis factor-α inhibitors using the Korea Adverse Events Reporting System Database, 2005-2016. Ha, D., Lee, SE., Song, I., et al.[2022]

In a survey of 17 European countries, it was found that while 13 have regulations for reporting adverse vaccine reactions, only six have full-time professionals dedicated to vaccine safety, highlighting a significant gap in resources and expertise.

The study revealed that reporting systems for adverse events following immunization (AEFI) are inconsistent across countries, with many lacking standardized definitions and reporting forms specifically designed for vaccines, which complicates the assessment of vaccine safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccinovigilance in Europe--need for timeliness, standardization and resources. Lankinen, KS., Pastila, S., Kilpi, T., et al.[2015]

Knee effusions can arise from various causes, including trauma, overuse, and systemic diseases, making a thorough medical history crucial for accurate diagnosis and treatment planning.

A systematic physical examination, along with diagnostic imaging and procedures like arthrocentesis, is essential for identifying the specific cause of knee effusions and determining the appropriate treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute knee effusions: a systematic approach to diagnosis. Johnson, MW.[2005]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Differential diagnosis of post-traumatic hydrarthrosis of the knee joint]. [2018]

2. England pubmed.ncbi.nlm.nih.gov

The prognostic significance of radiologically detected knee joint effusions in the absence of associated fracture. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Effusion detected by ultrasonography and overweight may predict the risk of knee osteoarthritis in females with early knee osteoarthritis: a retrospective analysis of Iwaki cohort data. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of aspiration in knee joint effusion management: a prospective randomized controlled study. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

[Capsule-ligament lesions of the knee joint. Early diagnosis, primary therapy, results]. [2016]

6. England pubmed.ncbi.nlm.nih.gov

Routine database registration of biological therapy increases the reporting of adverse events twentyfold in clinical practice. First results from the Danish Database (DANBIO). [2019]

7. England pubmed.ncbi.nlm.nih.gov

Adverse events in total knee arthroplasty: Results of a physician independent survey in 260 patients. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of Serious Adverse Event Profiles Among Antirheumatic Agents Using Japanese Adverse Drug Event Report Database. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

Comparison of signal detection of tumour necrosis factor-α inhibitors using the Korea Adverse Events Reporting System Database, 2005-2016. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Vaccinovigilance in Europe--need for timeliness, standardization and resources. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

Acute knee effusions: a systematic approach to diagnosis. [2005]