Changes in the Immunomodulatory Properties of Adipose Stromal Cells Due to Hemarthrosis After Knee Injury

Study Overview
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Brief Summary
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The goal of this observational study is to gain insight in the natural course of pro-inflammatory factors and hemarthrosis in patients older than 18 with a recent knee trauma. The main question[s] it aims to answer are: What is the natural course of pro-inflammatory factors and hemarthrosis in knee trauma? What are the effects of inflammation and hemarthrosis on the anti-inflammatory potential of ASC's in order to better determine eligible patients and circumstances for ASC's therapy? Participants will: undergo blood withdrawal undergo knee arthrocentesis for synovial fluid sample collection physical examination fill out a questionnaire on knee complaints

Detailed Description
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Recent studies have found an amelioration of post-traumatic osteoarthritis by the use of adipose-derived stromal cells (ASC's) in an experimental animal model. This amelioration was only seen under inflammatory conditions. The presence of hemarthrosis has not been taken into account in the before mentioned animal model, and might have cytotoxic effects on ASC's and aggravate the inflammatory response. The objective of this study is to gain insight in the natural course of pro-inflammatory factors and hemarthrosis and its effects on the anti-inflammatory potential of ASC's in order to better determine eligible patients and circumstances for ASC's therapy. Therefore the investigators designed a pilot study with exploratory analyses in and with synovial fluid in a longitudinal cohort. Our study population will consist of 20 patients, older than 18 years, who sustained a recent knee trauma and are presented to the emergency department.The investigators will gather synovial fluid and blood samples for laboratory analysis perform and physical examination and provide questionnaires for clinical follow-up. The main study endpoint are the anti-inflammatory capacities of ASC's in synovial fluid that contains blood as a result of hemarthrosis after knee injury.

Official Title
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Changes in the Immunomodulatory Properties of Adipose Stromal Cells Due to Hemarthrosis After Knee Injury

Conditions
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Post-Traumatic Osteoarthritis of Knee, Knee Injuries, Hemarthrosis

Intervention / Treatment
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* Procedure: knee arthrocentesis
* Procedure: venipuncture
* Diagnostic Test: MRI-scan
* Diagnostic Test: Physical examination
* Other: KOOS questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recently suffered an injury of the index knee (rotational or hyperextension) A swollen joint Inability to mobilise Exclusion Criteria: Patients with an active inflammatory or infectious comorbid disease (including rheumatic diseases) Patients using systemic immunosuppressant medication Patients with a contra-indication for undergoing a MRI-scan (non-compatible implants or claustrophobia for example) Patients with knee prosthesis Patients with coagulation disorders Patients with a history of a cruciate ligament or meniscal injury of the index knee Patients with a tibiofemoral fracture of the index knee due to current distortion In case the inclusion of the required amount of patient is reached in one the patient groups, additional patients belonging in the same patient group will not be included in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with hemarthrosis<br>10 patients that sustained a knee trauma and have hemarthrosis during knee arthrocentesis (red color of the synovial fluid) | Procedure: knee arthrocentesis<br>* arthrocentesis of the knee joint to gather a synovial fluid sample<br>Procedure: venipuncture<br>* Peripheral venipuncture to gather a blood sample<br>* Other names: blood draw;Diagnostic Test: MRI-scan<br>* MRI-scan of the knee<br>Diagnostic Test: Physical examination<br>* Physical examination of the injured knee<br>Other: KOOS questionnaire<br>* KOOS questionnaire of the injured knee<br>|
| Patients without hemarthrosis<br>10 patients that sustained a knee trauma and do not have hemarthrosis during knee arthrocentesis (yellow color of the synovial fluid) | Procedure: knee arthrocentesis<br>* arthrocentesis of the knee joint to gather a synovial fluid sample<br>Procedure: venipuncture<br>* Peripheral venipuncture to gather a blood sample<br>* Other names: blood draw;Diagnostic Test: MRI-scan<br>* MRI-scan of the knee<br>Diagnostic Test: Physical examination<br>* Physical examination of the injured knee<br>Other: KOOS questionnaire<br>* KOOS questionnaire of the injured knee<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Synovial fluid analysis | Analysis of changes in pro-inflammatory factors, erythrocytes (as measurement for hemarthrosis) | Samples are taken at week 1, week 2, week 4, week 6 and week 8 after trauma | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| co-culture of synovial fluid with adipose stromal cells | Assessment of changes in cytotoxity of hemarthrosis in synovial fluid on adipose stromal cells | samples are taken at week 1, week 2, week 4, week 6 and week 8 after trauma | 
| MRI-imaging | MRI-images to determine post-traumatic changes in the articulate cartilage | At inclusion and 1 year after trauma | 
| Physical examination | Assessment of changes in swelling, warmth and appearance of the skin | Physical examination at week 1, week 2, week 4, week 6 and week 8 after trauma | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire | Assessment changes of knee complaints by using the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire, with minimum score of 0 and a maximum score of 100 and a higher score meaning a better outcome. | Questionnaires are taken at week 1, week 2, week 4, week 6 and week 8 after trauma |