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

Phase 2

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: Triamcort; Drug: Placebo; Drug: Platelet-rich-plasma; Drug: Suplasyn1

• Registration Number: NCT02776514
• Lead Sponsor: Balgrist University Hospital

Brief 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.

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 Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-18
• Primary Completion: 2020-11
• Study Completion: 2020-11
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triamcort (1 ml, 40 mg/ml)	Triamcort	30 patients receive intraarticular injection with steroids (and contrast media Iopamiro 200)
Placebo (Iopamiro 200)	Placebo	30 patients receive intraarticular injection with contrast media only
Platelet-rich-plasma (PRP 3 ml)	Platelet-rich-plasma	30 patients receive intraarticular injection with platelet-rich-plasma (PRP) (and contrast media Iopamiro 200)
Suplasyn1-shot (60 mg/ ml)	Suplasyn1	30 patients receive intraarticular injection with hyaluronic acid (and contrast media Iopamiro 200)

Primary Outcome Measures

Name	Time	Method
Pain assessment	up to 24 months after injection	numeric rating scale (NRS) and WOMAC
Magnetic Resonance imaging	up to 12 months after injection	T2-values in cartilage (mean Signal +/- Standard Deviation) in subregions

Secondary Outcome Measures

Name	Time	Method
Tegner Activity Scale	up to 24 months after injection	Clinical outcome
Knee mobility and thigh circumference	3 month after injection	Clinical assessment, comparison to baseline
WOMAC score (stiffness, difficulty)	up to 24 months after injection	Clinical outcome

Trial Locations

Locations (1)

University Hospital Balgrist; 🇨🇭 Zurich, Switzerland