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

Recruiting

• Conditions: Post-Traumatic Osteoarthritis of Knee; Knee Injuries; Hemarthrosis
• Interventions: Procedure: knee arthrocentesis; Procedure: venipuncture; Diagnostic Test: MRI-scan; Diagnostic Test: Physical examination; Other: KOOS questionnaire

• Registration Number: NCT05687331
• Lead Sponsor: Radboud University Medical Center

Brief 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.

Study Timeline

• Study Start: 2022-04-05
• Status Verified: 2022-12
• Study First Submitted: 2022-12-13
• Study First Submitted QC: 2023-01-17
• Last Update Submitted: 2023-01-17
• Study First Posted: 2023-01-18
• Last Update Posted: 2023-01-18
• Primary Completion: 2023-04-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with hemarthrosis	knee arthrocentesis	10 patients that sustained a knee trauma and have hemarthrosis during knee arthrocentesis (red color of the synovial fluid)
Patients without hemarthrosis	MRI-scan	10 patients that sustained a knee trauma and do not have hemarthrosis during knee arthrocentesis (yellow color of the synovial fluid)
Patients without hemarthrosis	KOOS questionnaire	10 patients that sustained a knee trauma and do not have hemarthrosis during knee arthrocentesis (yellow color of the synovial fluid)
Patients with hemarthrosis	Physical examination	10 patients that sustained a knee trauma and have hemarthrosis during knee arthrocentesis (red color of the synovial fluid)
Patients without hemarthrosis	knee arthrocentesis	10 patients that sustained a knee trauma and do not have hemarthrosis during knee arthrocentesis (yellow color of the synovial fluid)
Patients without hemarthrosis	Physical examination	10 patients that sustained a knee trauma and do not have hemarthrosis during knee arthrocentesis (yellow color of the synovial fluid)
Patients with hemarthrosis	venipuncture	10 patients that sustained a knee trauma and have hemarthrosis during knee arthrocentesis (red color of the synovial fluid)
Patients with hemarthrosis	KOOS questionnaire	10 patients that sustained a knee trauma and have hemarthrosis during knee arthrocentesis (red color of the synovial fluid)
Patients with hemarthrosis	MRI-scan	10 patients that sustained a knee trauma and have hemarthrosis during knee arthrocentesis (red color of the synovial fluid)
Patients without hemarthrosis	venipuncture	10 patients that sustained a knee trauma and do not have hemarthrosis during knee arthrocentesis (yellow color of the synovial fluid)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
co-culture of synovial fluid with adipose stromal cells	samples are taken at week 1, week 2, week 4, week 6 and week 8 after trauma	Assessment of changes in cytotoxity of hemarthrosis in synovial fluid on adipose stromal cells
Physical examination	Physical examination at week 1, week 2, week 4, week 6 and week 8 after trauma	Assessment of changes in swelling, warmth and appearance of the skin
Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire	Questionnaires are taken at week 1, week 2, week 4, week 6 and week 8 after trauma	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.
MRI-imaging	At inclusion and 1 year after trauma	MRI-images to determine post-traumatic changes in the articulate cartilage

Trial Locations

Locations (1)

Radboud umc; 🇳🇱 Nijmegen, Gelderland, Netherlands