Steroids, Hyaluronic Acid or Platelet Rich Plasma Versus Placebo for the Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

Detailed Description
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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) Magnetic Resonance imaging (cartilage defects etc.)

Official Title
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Intraarticular Injections of Steroids, Hyaluronic Acid or Platelet Rich Plasma Versus Placebo for the Knee Osteoarthritis

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: Triamcort
* Drug: Platelet-rich-plasma
* Drug: Suplasyn1
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: gonarthritis Kellgren 1,2,3 with symptoms german speaking informed consent 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Triamcort (1 ml, 40 mg/ml)<br>30 patients receive intraarticular injection with steroids (and contrast media Iopamiro 200) | Drug: Triamcort<br>* Fluoroscopic guided injection in the knee joint<br>|
| Active Comparator: Platelet-rich-plasma (PRP 3 ml)<br>30 patients receive intraarticular injection with platelet-rich-plasma (PRP) (and contrast media Iopamiro 200) | Drug: Platelet-rich-plasma<br> <br> |
| Active Comparator: Suplasyn1-shot (60 mg/ ml)<br>30 patients receive intraarticular injection with hyaluronic acid (and contrast media Iopamiro 200) | Drug: Suplasyn1<br> <br> |
| Placebo Comparator: Placebo (Iopamiro 200)<br>30 patients receive intraarticular injection with contrast media only | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Knee mobility and thigh circumference | Clinical assessment, comparison to baseline | 3 month after injection |