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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2020-11-30

Brief Summary

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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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Detailed Description

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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.)

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Triamcort (1 ml, 40 mg/ml)

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

Group Type ACTIVE_COMPARATOR

Triamcort

Intervention Type DRUG

Fluoroscopic guided injection in the knee joint

Platelet-rich-plasma (PRP 3 ml)

30 patients receive intraarticular injection with platelet-rich-plasma (PRP) (and contrast media Iopamiro 200)

Group Type ACTIVE_COMPARATOR

Platelet-rich-plasma

Intervention Type DRUG

Suplasyn1-shot (60 mg/ ml)

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

Group Type ACTIVE_COMPARATOR

Suplasyn1

Intervention Type DRUG

Placebo (Iopamiro 200)

30 patients receive intraarticular injection with contrast media only

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Triamcort

Fluoroscopic guided injection in the knee joint

Intervention Type DRUG

Platelet-rich-plasma

Intervention Type DRUG

Suplasyn1

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No