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Completed

NCT Number: NCT02776514

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Balgrist

Zurich, 8008, Switzerland

About this study

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.)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triamcort

Drug

Fluoroscopic guided injection in the knee joint

Platelet-rich-plasma

Drug

Suplasyn1

Drug

Placebo

Drug

Primary outcomes

  1. Pain assessment

    Time frame: up to 24 months after injection

    numeric rating scale (NRS) and WOMAC

  2. Magnetic Resonance imaging

    Time frame: up to 12 months after injection

    cartilage volume (ml)

  3. Magnetic Resonance imaging

    Time frame: up to 12 months after injection

    T2-values in cartilage (mean Signal +/- Standard Deviation) in subregions

Secondary outcomes

  1. WOMAC score (stiffness, difficulty)

    Time frame: up to 24 months after injection

    Clinical outcome

  2. Tegner Activity Scale

    Time frame: up to 24 months after injection

    Clinical outcome

  3. Knee mobility and thigh circumference

    Time frame: 3 month after injection

    Clinical assessment, comparison to baseline

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Collaborators

  • Stiftung Marie-Lou Ringgenberg Bern
  • Stiftung für Rheumaforschung Zurich

Registry information

Official study title

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

Acronym: KIT

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 18, 2016
Registry last updated
Feb 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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