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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: Placebo; Drug: Triamcort; Drug: Platelet-rich-plasma; Drug: Suplasyn1

Detailed 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.)

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8008
    • University Hospital Balgrist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Balgrist University Hospital
• Collaborators: Stiftung für Rheumaforschung Zurich; Stiftung Marie-Lou Ringgenberg Bern
• Investigators: Principal Investigator: Andrea B Rosskopf, MD, Radiology University Hospital Balgrist

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (Estimate): May 18, 2016

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: W-560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No