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

NCT05687331 | Unknown DMC

• 1 other identifier: NL77974.091.21
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Post-Traumatic Osteoarthritis of Knee; Knee Injuries; Hemarthrosis

Outcome Measures

Primary Outcomes (1)

• Synovial fluid analysis

  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 Outcomes (4)

• 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

• MRI-imaging

  At inclusion and 1 year after trauma

• Physical examination

  Physical examination at week 1, week 2, week 4, week 6 and week 8 after trauma

• 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

Study Arms (2)

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; Procedure: venipuncture; Diagnostic Test: MRI-scan; Diagnostic Test: Physical examination; Other: KOOS questionnaire

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; Procedure: venipuncture; Diagnostic Test: MRI-scan; Diagnostic Test: Physical examination; Other: KOOS questionnaire

Interventions

knee arthrocentesis PROCEDURE

arthrocentesis of the knee joint to gather a synovial fluid sample

Patients with hemarthrosis; Patients without hemarthrosis

venipuncture PROCEDURE

Peripheral venipuncture to gather a blood sample

Also known as: blood draw

Patients with hemarthrosis; Patients without hemarthrosis

MRI-scan DIAGNOSTIC_TEST

MRI-scan of the knee

Patients with hemarthrosis; Patients without hemarthrosis

Physical examination DIAGNOSTIC_TEST

Physical examination of the injured knee

Patients with hemarthrosis; Patients without hemarthrosis

KOOS questionnaire OTHER

KOOS questionnaire of the injured knee

Patients with hemarthrosis; Patients without hemarthrosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Recently suffered an injury of the index knee (rotational or hyperextension)
• A swollen joint
• Inability to mobilise

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud umc

Nijmegen, Gelderland, 6525GA, Netherlands

RECRUITING

Related Publications (10)

• Riordan EA, Little C, Hunter D. Pathogenesis of post-traumatic OA with a view to intervention. Best Pract Res Clin Rheumatol. 2014 Feb;28(1):17-30. doi: 10.1016/j.berh.2014.02.001.

  PMID: 24792943 BACKGROUND

• Lohmander LS, Englund PM, Dahl LL, Roos EM. The long-term consequence of anterior cruciate ligament and meniscus injuries: osteoarthritis. Am J Sports Med. 2007 Oct;35(10):1756-69. doi: 10.1177/0363546507307396. Epub 2007 Aug 29.

  PMID: 17761605 BACKGROUND

• Luc B, Gribble PA, Pietrosimone BG. Osteoarthritis prevalence following anterior cruciate ligament reconstruction: a systematic review and numbers-needed-to-treat analysis. J Athl Train. 2014 Nov-Dec;49(6):806-19. doi: 10.4085/1062-6050-49.3.35.

  PMID: 25232663 BACKGROUND

• Ayral X, Pickering EH, Woodworth TG, Mackillop N, Dougados M. Synovitis: a potential predictive factor of structural progression of medial tibiofemoral knee osteoarthritis -- results of a 1 year longitudinal arthroscopic study in 422 patients. Osteoarthritis Cartilage. 2005 May;13(5):361-7. doi: 10.1016/j.joca.2005.01.005.

  PMID: 15882559 BACKGROUND

• Pulles AE, Mastbergen SC, Schutgens RE, Lafeber FP, van Vulpen LF. Pathophysiology of hemophilic arthropathy and potential targets for therapy. Pharmacol Res. 2017 Jan;115:192-199. doi: 10.1016/j.phrs.2016.11.032. Epub 2016 Nov 24.

  PMID: 27890816 BACKGROUND

• Gupte C, St Mart JP. The acute swollen knee: diagnosis and management. J R Soc Med. 2013 Jul;106(7):259-68. doi: 10.1177/0141076813482831.

  PMID: 23821708 BACKGROUND

• Wang Y, Shimmin A, Ghosh P, Marks P, Linklater J, Connell D, Hall S, Skerrett D, Itescu S, Cicuttini FM. Safety, tolerability, clinical, and joint structural outcomes of a single intra-articular injection of allogeneic mesenchymal precursor cells in patients following anterior cruciate ligament reconstruction: a controlled double-blind randomised trial. Arthritis Res Ther. 2017 Aug 2;19(1):180. doi: 10.1186/s13075-017-1391-0.

  PMID: 28768528 BACKGROUND

• ter Huurne M, Schelbergen R, Blattes R, Blom A, de Munter W, Grevers LC, Jeanson J, Noel D, Casteilla L, Jorgensen C, van den Berg W, van Lent PL. Antiinflammatory and chondroprotective effects of intraarticular injection of adipose-derived stem cells in experimental osteoarthritis. Arthritis Rheum. 2012 Nov;64(11):3604-13. doi: 10.1002/art.34626.

  PMID: 22961401 BACKGROUND

• Schelbergen RF, van Dalen S, ter Huurne M, Roth J, Vogl T, Noel D, Jorgensen C, van den Berg WB, van de Loo FA, Blom AB, van Lent PL. Treatment efficacy of adipose-derived stem cells in experimental osteoarthritis is driven by high synovial activation and reflected by S100A8/A9 serum levels. Osteoarthritis Cartilage. 2014 Aug;22(8):1158-66. doi: 10.1016/j.joca.2014.05.022. Epub 2014 Jun 10.

  PMID: 24928317 BACKGROUND

• Pers YM, Rackwitz L, Ferreira R, Pullig O, Delfour C, Barry F, Sensebe L, Casteilla L, Fleury S, Bourin P, Noel D, Canovas F, Cyteval C, Lisignoli G, Schrauth J, Haddad D, Domergue S, Noeth U, Jorgensen C; ADIPOA Consortium. Adipose Mesenchymal Stromal Cell-Based Therapy for Severe Osteoarthritis of the Knee: A Phase I Dose-Escalation Trial. Stem Cells Transl Med. 2016 Jul;5(7):847-56. doi: 10.5966/sctm.2015-0245. Epub 2016 May 23.

  PMID: 27217345 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood plasma, synovial fluid

MeSH Terms

Conditions

Knee Injuries; Hemarthrosis

Interventions

Phlebotomy; Blood Specimen Collection; Magnetic Resonance Imaging; Physical Examination

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Tomography; Diagnostic Imaging

Central Study Contacts

Bob Evers, Drs/Msc

CONTACT

06-29630837; Bob.J.Evers@radboudumc.nl

Rogier Thurlings, Dr/PhD

CONTACT

0629652920; rogier.thurlings@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: January 18, 2023
• Study Start: April 5, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2024
• Last Updated: January 18, 2023

Record last verified: 2022-12

Locations

NL (1)