NCT05687331

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Post-Traumatic Osteoarthritis of Knee
• Knee Injuries
• Hemarthrosis

Interventions

Type	Name	Description
PROCEDURE	knee arthrocentesis	arthrocentesis of the knee joint to gather a synovial fluid sample
PROCEDURE	venipuncture	Peripheral venipuncture to gather a blood sample
DIAGNOSTIC_TEST	MRI-scan	MRI-scan of the knee
DIAGNOSTIC_TEST	Physical examination	Physical examination of the injured knee
OTHER	KOOS questionnaire	KOOS questionnaire of the injured knee

Timeline

• Start date: 2022-04-05
• Primary completion: 2023-04-01
• Completion: 2024-04-01
• First posted: 2023-01-18
• Last updated: 2023-01-18

Locations

1 site across 1 country: Netherlands