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

Osteoarthritis, Knee Clinical Trial

— KIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02776514
• Other study ID #: W-560
• Status: Completed
• Phase: Phase 2
• Start date: February 2016
• Est. completion date: November 2020

Study information

• Verified date: January 2022
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Triamcort
Fluoroscopic guided injection in the knee joint
• Platelet-rich-plasma

• Suplasyn1

• Placebo

Locations

Country	Name	City	State
Switzerland	University Hospital Balgrist	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
Balgrist University Hospital	Stiftung für Rheumaforschung Zurich, Stiftung Marie-Lou Ringgenberg Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessment	numeric rating scale (NRS) and WOMAC	up to 24 months after injection
Primary	Magnetic Resonance imaging	cartilage volume (ml)	up to 12 months after injection
Primary	Magnetic Resonance imaging	T2-values in cartilage (mean Signal +/- Standard Deviation) in subregions	up to 12 months after injection
Secondary	WOMAC score (stiffness, difficulty)	Clinical outcome	up to 24 months after injection
Secondary	Tegner Activity Scale	Clinical outcome	up to 24 months after injection
Secondary	Knee mobility and thigh circumference	Clinical assessment, comparison to baseline	3 month after injection