An observational study in Post-Traumatic Osteoarthritis of Knee, Knee Injuries and Hemarthrosis, sponsored by Radboud University Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by Radboud University Medical Center · Observational
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:
Participants will:
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.
267 studies on the registry are indexed under Knee Injuries; 59 are open to participants now.
This study's planned enrollment of 20 is below the median of 82 across 79 observational studies indexed under Knee Injuries.
Browse Knee Injuries studies →Radboud University Medical Center is the lead sponsor of 986 studies on the registry; 136 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients who are presented at the emergency department of the CWZ hospital because of a recent distortion of the knee.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
10 patients that sustained a knee trauma and have hemarthrosis during knee arthrocentesis (red color of the synovial fluid)
Procedure: knee arthrocentesis · Procedure: venipuncture · Diagnostic Test: MRI-scan · Diagnostic Test: Physical examination · Other: KOOS questionnaire
10 patients that sustained a knee trauma and do not have hemarthrosis during knee arthrocentesis (yellow color of the synovial fluid)
Procedure: knee arthrocentesis · Procedure: venipuncture · Diagnostic Test: MRI-scan · Diagnostic Test: Physical examination · Other: KOOS questionnaire
arthrocentesis of the knee joint to gather a synovial fluid sample
Peripheral venipuncture to gather a blood sample
Also known as: blood draw
MRI-scan of the knee
Physical examination of the injured knee
KOOS questionnaire of the injured knee
Synovial fluid analysis
Analysis of changes in pro-inflammatory factors, erythrocytes (as measurement for hemarthrosis)
Time frame: Samples are taken at week 1, week 2, week 4, week 6 and week 8 after trauma
co-culture of synovial fluid with adipose stromal cells
Assessment of changes in cytotoxity of hemarthrosis in synovial fluid on adipose stromal cells
Time frame: 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
Time frame: At inclusion and 1 year after trauma
Physical examination
Assessment of changes in swelling, warmth and appearance of the skin
Time frame: 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.
Time frame: Questionnaires are taken at week 1, week 2, week 4, week 6 and week 8 after trauma
Plan to share: Undecided
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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