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

January 17, 2023 updated by: Radboud University Medical Center

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients who are presented at the emergency department of the CWZ hospital because of a recent distortion of the knee.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with hemarthrosis
10 patients that sustained a knee trauma and have hemarthrosis during knee arthrocentesis (red color of the synovial fluid)
Procedure: knee arthrocentesis
arthrocentesis of the knee joint to gather a synovial fluid sample
Procedure: venipuncture
Peripheral venipuncture to gather a blood sample
Other Names:
  • blood draw
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
Patients without hemarthrosis
10 patients that sustained a knee trauma and do not have hemarthrosis during knee arthrocentesis (yellow color of the synovial fluid)
Procedure: knee arthrocentesis
arthrocentesis of the knee joint to gather a synovial fluid sample
Procedure: venipuncture
Peripheral venipuncture to gather a blood sample
Other Names:
  • blood draw
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Synovial fluid analysis
Time Frame: 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)
Samples are taken at week 1, week 2, week 4, week 6 and week 8 after trauma

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
co-culture of synovial fluid with adipose stromal cells
Time Frame: 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
samples are taken at week 1, week 2, week 4, week 6 and week 8 after trauma
MRI-imaging
Time Frame: At inclusion and 1 year after trauma
MRI-images to determine post-traumatic changes in the articulate cartilage
At inclusion and 1 year after trauma
Physical examination
Time Frame: 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
Physical examination at week 1, week 2, week 4, week 6 and week 8 after trauma
Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Time Frame: 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.
Questionnaires are taken at week 1, week 2, week 4, week 6 and week 8 after trauma

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL77974.091.21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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