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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05687331
Acronym
CASH
Enrollment
20
Registered
2023-01-18
Start date
2022-04-05
Completion date
2024-04-01
Last updated
2023-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemarthrosis, Knee Injuries, Post-Traumatic Osteoarthritis of Knee

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.

Interventions

PROCEDUREknee arthrocentesis

arthrocentesis of the knee joint to gather a synovial fluid sample

PROCEDUREvenipuncture

Peripheral venipuncture to gather a blood sample

DIAGNOSTIC_TESTMRI-scan

MRI-scan of the knee

DIAGNOSTIC_TESTPhysical examination

Physical examination of the injured knee

OTHERKOOS questionnaire

KOOS questionnaire of the injured knee

Sponsors

Radboud University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Synovial fluid analysisSamples are taken at week 1, week 2, week 4, week 6 and week 8 after traumaAnalysis of changes in pro-inflammatory factors, erythrocytes (as measurement for hemarthrosis)

Secondary

MeasureTime frameDescription
co-culture of synovial fluid with adipose stromal cellssamples are taken at week 1, week 2, week 4, week 6 and week 8 after traumaAssessment of changes in cytotoxity of hemarthrosis in synovial fluid on adipose stromal cells
MRI-imagingAt inclusion and 1 year after traumaMRI-images to determine post-traumatic changes in the articulate cartilage
Physical examinationPhysical examination at week 1, week 2, week 4, week 6 and week 8 after traumaAssessment of changes in swelling, warmth and appearance of the skin
Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaireQuestionnaires are taken at week 1, week 2, week 4, week 6 and week 8 after traumaAssessment 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.

Countries

Netherlands

Contacts

Primary ContactBob Evers, Drs/Msc
Bob.J.Evers@radboudumc.nl06-29630837
Backup ContactRogier Thurlings, Dr/PhD
rogier.thurlings@radboudumc.nl0629652920

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026