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

Balgrist University Hospital

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis, Knee

Treatments: Drug: Triamcort; Drug: Platelet-rich-plasma; Drug: Placebo; Drug: Suplasyn1

Study type: Interventional

Funder types: Other

Identifiers

NCT02776514

W-560

Details and patient eligibility

About

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.

Full description

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.)

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 4 patient groups, including a placebo group

Triamcort (1 ml, 40 mg/ml)

Active Comparator group

Description:

30 patients receive intraarticular injection with steroids (and contrast media Iopamiro 200)

Treatment:

Drug: Triamcort

Platelet-rich-plasma (PRP 3 ml)

Active Comparator group

Description:

30 patients receive intraarticular injection with platelet-rich-plasma (PRP) (and contrast media Iopamiro 200)

Treatment:

Drug: Platelet-rich-plasma

Suplasyn1-shot (60 mg/ ml)

Active Comparator group

Description:

30 patients receive intraarticular injection with hyaluronic acid (and contrast media Iopamiro 200)

Treatment:

Drug: Suplasyn1

Placebo (Iopamiro 200)

Placebo Comparator group

Description:

30 patients receive intraarticular injection with contrast media only

Treatment:

Drug: Placebo