Trial | NCT02776514  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    120
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)

Magnetic Resonance imaging (cartilage defects etc.)
Study Started
Feb 29
2016
Primary Completion
Nov 30
2020
Study Completion
Nov 30
2020
Last Update
Feb 07
2022

Drug Triamcort

Fluoroscopic guided injection in the knee joint

Drug Platelet-rich-plasma

Drug Suplasyn1

Drug Placebo

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

Criteria 

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.
No Results Posted