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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with hemarthrosis | 10 patients that sustained a knee trauma and have hemarthrosis during knee arthrocentesis (red color of the synovial fluid) |
| |
| Patients without hemarthrosis | 10 patients that sustained a knee trauma and do not have hemarthrosis during knee arthrocentesis (yellow color of the synovial fluid) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| knee arthrocentesis | Procedure | arthrocentesis of the knee joint to gather a synovial fluid sample |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| co-culture of synovial fluid with adipose stromal cells | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients who are presented at the emergency department of the CWZ hospital because of a recent distortion of the knee.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bob Evers, Drs/Msc | Contact | 06-29630837 | Bob.J.Evers@radboudumc.nl | |
| Rogier Thurlings, Dr/PhD | Contact | 0629652920 | rogier.thurlings@radboudumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud umc | Recruiting | Nijmegen | Gelderland | 6525GA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24792943 | Background | 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. | |
| 17761605 | 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. |
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blood plasma, synovial fluid
| venipuncture | Procedure | Peripheral venipuncture to gather a blood sample |
|
|
| MRI-scan | Diagnostic Test | MRI-scan of the knee |
|
| Physical examination | Diagnostic Test | Physical examination of the injured knee |
|
| KOOS questionnaire | Other | KOOS questionnaire of the injured knee |
|
MRI-images to determine post-traumatic changes in the articulate cartilage
| At inclusion and 1 year after trauma |
| Physical examination | 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 | 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 |
| 25232663 | 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. |
| 15882559 | 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. |
| 27890816 | 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. |
| 23821708 | 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. |
| 28768528 | 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. |
| 22961401 | 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. |
| 24928317 | 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. |
| 27217345 | 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. |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D006395 | Hemarthrosis |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D018962 | Phlebotomy |
| D001800 | Blood Specimen Collection |
| D008279 | Magnetic Resonance Imaging |
| D010808 | Physical Examination |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
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