Knee Joint Effusion for Knee Injuries
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Duke University
No Placebo Group
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.
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.
567910What 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.
123811Will I have to stop taking my current medications?
If you are currently taking pain-altering medication, you cannot participate in this trial.
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.
12348Eligibility 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.
I am between 18 and 35 years old.
Exclusion Criteria
I am currently on medication to manage pain.
I have had surgery on my lower back or legs.
I have had a leg or lower back injury in the last 6 months.
I have a neurological, autoimmune, or heart condition.
I am experiencing knee pain.
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Knee Joint EffusionExperimental Treatment1 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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Michael W. Krzyzewski Human Performance LaboratoryDurham, NC
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Who is running the clinical trial?
Duke UniversityLead Sponsor
References
The prognostic significance of radiologically detected knee joint effusions in the absence of associated fracture. [2016]The significance of radiologically detected knee joint effusion as a marker of soft tissue injury following trauma is uncertain. In this study 100 patients presenting to the casualty department following acute injury, with effusions but no fracture, were assessed. Of those available for follow-up, 20% required further investigation and 11% proceeded to surgery for significant soft tissue injury. It is concluded that radiologically detected knee joint effusions are a useful marker for underlying soft tissue injury.
[Capsule-ligament lesions of the knee joint. Early diagnosis, primary therapy, results]. [2016]Roughly ten per cent of the capacity of casualty surgery are absorbed by injuries of the knee joint which also account for 30 per cent of all sports injuries. Emergency arthroscopy should be indicated for any case of post-traumatic articular effusion. Primary treatment should be rendered within two or three days from the accident. This should be immediately followed by rehabilitation to preserve muscular strength.
[Differential diagnosis of post-traumatic hydrarthrosis of the knee joint]. [2018]You can diagnose the post-traumatic effusion in a knee-joint generally without difficulty. The fresh effusion is very often bloody. Reflections concerning differential diagnosis are necessary to recognize heavy injuries of soft-tissue and bony injuries. For the diagnostic special X-rays are useful, the arthroscopy and the arthrography. The joint must immediately be unburdened because the effusion can take a negative effect on the articular.
Acute knee effusions: a systematic approach to diagnosis. [2005]Knee effusions may be the result of trauma, overuse or systemic disease. An understanding of knee pathoanatomy is an invaluable part of making the correct diagnosis and formulating a treatment plan. Taking a thorough medical history is the key component of the evaluation. The most common traumatic causes of knee effusion are ligamentous, osseous and meniscal injuries, and overuse syndromes. Atraumatic etiologies include arthritis, infection, crystal deposition and tumor. It is essential to compare the affected knee with the unaffected knee. Systematic physical examination of the knee, using specific maneuvers, and the appropriate use of diagnostic imaging studies and arthrocentesis establish the correct diagnosis and treatment.
Vaccinovigilance in Europe--need for timeliness, standardization and resources. [2015]To identify gaps in the systems for reporting adverse events following immunization (AEFI) in Europe by means of an interactive database constructed using a standardized approach.
Routine database registration of biological therapy increases the reporting of adverse events twentyfold in clinical practice. First results from the Danish Database (DANBIO). [2019]To present from the Danish Database for Biological Therapies in Rheumatology (DANBIO) the frequencies and types of adverse events as well as risk factors during treatment with biological agents in clinical practice.
Adverse events in total knee arthroplasty: Results of a physician independent survey in 260 patients. [2021]Identification of all common and potentially avoidable adverse events is crucial to further improve the quality of medical care. The intention of the current study was to evaluate a standardized physician independent survey format on adverse events in total knee arthroplasty. The protocol for reporting adverse drug events following the International Conference of Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH) was adopted for adverse events occurring during surgical interventions.
Effectiveness of aspiration in knee joint effusion management: a prospective randomized controlled study. [2021]Knee effusion is a common symptom in various knee disorders of both traumatic and non-traumatic aetiology. Although intra-articular aspiration is a widespread treatment approach, its beneficial effect has not been confirmed by a randomized controlled study. The purpose was to evaluate the effectiveness and safety of joint aspiration in acute knee effusion, in relation to traumatic or non-traumatic aetiology.
Comparison of Serious Adverse Event Profiles Among Antirheumatic Agents Using Japanese Adverse Drug Event Report Database. [2020]The association between drugs and adverse events (AEs) has been investigated using various AE databases. The aim of this study was to provide useful information for risk minimization of antirheumatic agents by investigating the safety profiles of antirheumatic agents using the Japanese Adverse Drug Event Report database (JADER), focusing on some important serious AEs (SAEs) and their relation to time.
Comparison of signal detection of tumour necrosis factor-α inhibitors using the Korea Adverse Events Reporting System Database, 2005-2016. [2022]There are no pharmacovigilance studies on adverse event (AE) data for tumour necrosis factor alpha (TNFα) inhibitors in South Korea. We analysed AEs induced by adalimumab, infliximab, and etanercept METHODS: We used data from the Korea Institute of Drug Safety and Risk Management-Korea Adverse Events Reporting System Database (KIDS-KD) collected between 2005 and 2016. We used three different signal detection methods: proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). The drug was compared with drug labels in the USA and Korea. Logistic regression analysis identified AEs that are more likely to occur with drug use.
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]Knee osteoarthritis (OA) has enormous medical and socioeconomic burdens, which early diagnosis and intervention can reduce. We investigated the influence of knee effusion on the progression of knee OA in patients with early knee OA.