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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02776514
Acronym
KIT
Enrollment
120
Registered
2016-05-18
Start date
2016-02-29
Completion date
2020-11-30
Last updated
2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

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.)

Interventions

DRUGTriamcort

Fluoroscopic guided injection in the knee joint

DRUGSuplasyn1
DRUGPlacebo

Sponsors

Stiftung für Rheumaforschung Zurich
CollaboratorUNKNOWN
Stiftung Marie-Lou Ringgenberg Bern
CollaboratorUNKNOWN
Balgrist University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain assessmentup to 24 months after injectionnumeric rating scale (NRS) and WOMAC
Magnetic Resonance imagingup to 12 months after injectioncartilage volume (ml)

Secondary

MeasureTime frameDescription
WOMAC score (stiffness, difficulty)up to 24 months after injectionClinical outcome
Tegner Activity Scaleup to 24 months after injectionClinical outcome
Knee mobility and thigh circumference3 month after injectionClinical assessment, comparison to baseline

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026