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CompletedNCT02776514KITUpdated Feb 7, 2022

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

A Phase 2 interventional study of Triamcort and Platelet-rich-plasma in Osteoarthritis, Knee, sponsored by Balgrist University Hospital. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-07.

Sponsored by Balgrist University Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.)
02

Conditions studied

  • Osteoarthritis, Knee
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 120 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Balgrist University Hospital is the lead sponsor of 80 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • gonarthritis Kellgren 1,2,3 with symptoms
  • german speaking
  • informed consent

Exclusion criteria

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    Triamcort (1 ml, 40 mg/ml)

    30 patients receive intraarticular injection with steroids (and contrast media Iopamiro 200)

    Drug: Triamcort

  • 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

Interventions

  • DrugTriamcort

    Fluoroscopic guided injection in the knee joint

  • DrugPlatelet-rich-plasma
  • DrugSuplasyn1
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Pain assessment

    numeric rating scale (NRS) and WOMAC

    Time frame: up to 24 months after injection

  2. Magnetic Resonance imaging

    cartilage volume (ml)

    Time frame: up to 12 months after injection

  3. Magnetic Resonance imaging

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

    Time frame: up to 12 months after injection

Secondary outcomes

  1. WOMAC score (stiffness, difficulty)

    Clinical outcome

    Time frame: up to 24 months after injection

  2. Tegner Activity Scale

    Clinical outcome

    Time frame: up to 24 months after injection

  3. Knee mobility and thigh circumference

    Clinical assessment, comparison to baseline

    Time frame: 3 month after injection

07

Study locations

1 site
  • University Hospital Balgrist
    Zurich, 8008, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02776514
Lead sponsor
Balgrist University Hospital
Collaborators
Stiftung für Rheumaforschung Zurich, Stiftung Marie-Lou Ringgenberg Bern
Responsible party
Sponsor
First posted
May 18, 2016
Start date
Feb 2016
Primary completion
Nov 2020
Completion
Nov 2020
Last update
Feb 7, 2022

Study contacts

Andrea B Rosskopf, MD
principal investigator · Radiology University Hospital Balgrist

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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