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| Name | Class |
|---|---|
| Stiftung für Rheumaforschung Zurich | UNKNOWN |
| Stiftung Marie-Lou Ringgenberg Bern | UNKNOWN |
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This study investigates clinical outcome and imaging outcome parameters after intraarticular injection of steroids, platelet-rich-plasma (prp), hyaluronic acid or placebo in patients with early osteoarthritis of the knee joint.
Osteoarthritis of the knee joint is a very common disease in middle aged and elderly patients. This study evaluates the efficiency of different commonly used substances for intraarticular, non-operative treatment in early stages of this disease.
120 patients receive an fluoroscopic guided injection in the knee joint: 30 patients get injection with steroids 30 patients get injection with prp 30 patients get injection with hyaluronic acid 30 patients get injection with placebo (iopamiro contrast media)
Primary outcome: - clinical outcome (pain using numeric rating scale)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triamcort (1 ml, 40 mg/ml) | Active Comparator | 30 patients receive intraarticular injection with steroids (and contrast media Iopamiro 200) |
|
| Platelet-rich-plasma (PRP 3 ml) | Active Comparator | 30 patients receive intraarticular injection with platelet-rich-plasma (PRP) (and contrast media Iopamiro 200) |
|
| Suplasyn1-shot (60 mg/ ml) | Active Comparator | 30 patients receive intraarticular injection with hyaluronic acid (and contrast media Iopamiro 200) |
|
| Placebo (Iopamiro 200) | Placebo Comparator | 30 patients receive intraarticular injection with contrast media only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcort | Drug | Fluoroscopic guided injection in the knee joint |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessment | numeric rating scale (NRS) and WOMAC | up to 24 months after injection |
| Magnetic Resonance imaging | cartilage volume (ml) | up to 12 months after injection |
| Magnetic Resonance imaging | T2-values in cartilage (mean Signal +/- Standard Deviation) in subregions | up to 12 months after injection |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC score (stiffness, difficulty) | Clinical outcome | up to 24 months after injection |
| Tegner Activity Scale | Clinical outcome | up to 24 months after injection |
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Inclusion criteria:
Exclusion criteria:
-age under 18, gonarthritis, Kellgren 4, anticoagulation therapy, known inflammatory disease or infection, cardiovascular disease NYHA IV, immunosuppression, contraindication for MRI, pregnancy, no informed consent, NSAR 3 days before injection, etc.
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| Name | Affiliation | Role |
|---|---|---|
| Andrea B Rosskopf, MD | Radiology University Hospital Balgrist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Balgrist | Zurich | 8008 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38421679 | Derived | Tschopp M, Pfirrmann CWA, Brunner F, Fucentese SF, Galley J, Stern C, Sutter R, Catanzaro S, Kuhne N, Rosskopf AB. Morphological and Quantitative Parametric MRI Follow-up of Cartilage Changes Before and After Intra-articular Injection Therapy in Patients With Mild to Moderate Knee Osteoarthritis: A Randomized, Placebo-Controlled Trial. Invest Radiol. 2024 Sep 1;59(9):646-655. doi: 10.1097/RLI.0000000000001067. Epub 2024 Feb 28. | |
| 36728848 |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Platelet-rich-plasma |
| Drug |
|
| Suplasyn1 | Drug |
|
| Placebo | Drug |
|
| Knee mobility and thigh circumference | Clinical assessment, comparison to baseline | 3 month after injection |
| Derived |
| Tschopp M, Pfirrmann CWA, Fucentese SF, Brunner F, Catanzaro S, Kuhne N, Zwyssig I, Sutter R, Gotschi T, Tanadini M, Rosskopf AB. A Randomized Trial of Intra-articular Injection Therapy for Knee Osteoarthritis. Invest Radiol. 2023 May 1;58(5):355-362. doi: 10.1097/RLI.0000000000000942. Epub 2022 Dec 27. |
| D012216 |
| Rheumatic Diseases |