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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a wearable sensor detects changes in knee joint load handling. Researchers use a temporary knee joint effusion (an injection of fluid into the knee) to simulate common knee changes. The goal is to assess the sensor's ability to detect these changes during activities like walking. Individuals who are physically active (exercising at least 30 minutes, three times a week) and have no recent knee injuries or surgeries may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance knee health monitoring.

Will I have to stop taking my current medications?

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

What prior data suggests that this wearable sensor is safe for detecting changes in knee joint loading?

Research has shown that injecting a saltwater solution, called saline, into the knee is generally safe for most people. Studies have found that these injections can help reduce long-term knee pain. Most participants in these studies reported feeling better and moving more easily after receiving the injection.

A board-certified orthopedic surgeon carefully manages the injection process in this study, using ultrasound to guide the injection safely into the knee. The study also follows up with participants to address any potential risks, enhancing the procedure's safety.

In summary, research suggests that saline injections into the knee are well-tolerated and can provide some pain relief. Participants can feel reassured about the safety of this procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for knee injuries, like physical therapy and pain medications, focus on reducing symptoms over time. But knee joint effusion is unique because it involves a direct, one-time injection of sterile saline into the knee joint, specifically targeting the suprapatellar space. This method, guided by ultrasound for precision, might provide immediate relief by reducing inflammation and facilitating joint movement. Researchers are excited about this treatment because it could offer a faster, non-invasive option for alleviating knee pain and improving mobility without the need for ongoing medication or surgery.

What evidence suggests that this device is effective for detecting changes in knee joint loading?

Research has shown that knee joint effusion, or extra fluid in the knee joint, can relieve pain and improve movement. One study with 167 patients who had knee effusion found that removing the fluid provided temporary relief in these areas. This finding suggests that changes in the knee, such as those caused by extra fluid, can significantly affect knee function. In this trial, participants will receive a one-time injection of 60mL of sterile saline into the suprapatellar space to study its effects. Using a wearable sensor may help detect changes in knee function. This method could offer a useful and low-cost way to monitor and manage knee injuries. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 either male or female.

Exclusion Criteria

Pregnancy

History of major ligamentous damage

Fear of needles

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK532279/

Knee Effusion - StatPearls - NCBI Bookshelf - NIH A knee effusion refers to an abnormal fluid accumulation within the knee joint. Knee effusions can arise from traumatic injuries, such as ligament tears or ...

2. aafp.org aafp.org/pubs/afp/issues/2000/0415/p2391.html

Acute Knee Effusions: A Systematic Approach to Diagnosis The most common traumatic causes of knee effusion are ligamentous, osseous and meniscal injuries, and overuse syndromes.

3. withpower.com withpower.com/trial/phase-knee-injuries-2019-7ebda

Knee Joint Effusion for Knee Injuries 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 ...

4. nature.com nature.com/articles/s41598-022-07092-9

Automatic estimation of knee effusion from limited MRI data Joint effusion at 6 months is a significant predictor of joint effusion 1 year after anterior cruciate ligament reconstruction. Knee Surg.

5. mdpi.com mdpi.com/2075-4418/14/17/1900

Deep Learning-Based Joint Effusion Classification in Adult ... To automatically detect knee effusion on radiographs, we utilized a state-of-the-art (SOTA) deep learning-based classification model with a novel preprocessing ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/12571845/

Safety and efficacy of long-term intraarticular steroid ... Conclusion: Our findings support the long-term safety of IA steroid injections for patients with symptomatic knee OA.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0049017216300099

Clinical benefit of intra-articular saline as a comparator in ... Long-term knee pain was significantly decreased following IA injection with saline in 19 studies involving 1445 patients (SMD = −0.61; 95% CI: −0.76 to −0.45; ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9568422/

A comprehensive review of intraarticular knee injection ... Overall, most participants in the study experienced a safe, satisfactory and substantial decrease in pain and improved ability to perform daily ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0749806321002218

Safety and Efficacy of an Amniotic Suspension Allograft ... Patient-reported outcomes, including Knee Injury and Osteoarthritis Outcome Score (KOOS) and visual analog scale (VAS) score, were collected at multiple time ...

10. researchgate.net researchgate.net/publication/308150619_The_Therapeutic_Effect_of_Intra-Articular_Normal_Saline_Injections_in_Knee_Osteoarthritis_A_Meta-Analysis_of_Level_One_Studies

The Therapeutic Effect of Intra-Articular Normal Saline ... Two meta-analyses that focused on the efficacy of intra-articular normal saline injections for knee osteoarthritis demonstrated therapeutic ...