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

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Phase 2

Locations

Switzerland

Study Type

Interventional

Intervention

Triamcort

Platelet-rich-plasma

Suplasyn1

Placebo

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Hospital Balgrist

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Triamcort (1 ml, 40 mg/ml)

Platelet-rich-plasma (PRP 3 ml)

Suplasyn1-shot (60 mg/ ml)

Placebo (Iopamiro 200)

Arm Description

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

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

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

30 patients receive intraarticular injection with contrast media only

Outcomes

Primary Outcome Measures

Pain assessment

numeric rating scale (NRS) and WOMAC

Magnetic Resonance imaging

cartilage volume (ml)

Magnetic Resonance imaging

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

Secondary Outcome Measures

WOMAC score (stiffness, difficulty)

Clinical outcome

Tegner Activity Scale

Clinical outcome

Knee mobility and thigh circumference

Clinical assessment, comparison to baseline

Full Information

NCT ID

NCT02776514

First Posted

February 18, 2016

Last Updated

January 27, 2022

Sponsor

Balgrist University Hospital

Collaborators

Stiftung für Rheumaforschung Zurich, Stiftung Marie-Lou Ringgenberg Bern

1. Study Identification

Unique Protocol Identification Number

NCT02776514

Brief Title

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

Acronym

KIT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

February 2016 (undefined)

Primary Completion Date

November 2020 (Actual)

Study Completion Date

November 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Balgrist University Hospital

Collaborators

Stiftung für Rheumaforschung Zurich, Stiftung Marie-Lou Ringgenberg Bern

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Triamcort (1 ml, 40 mg/ml)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Platelet-rich-plasma (PRP 3 ml)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Suplasyn1-shot (60 mg/ ml)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo (Iopamiro 200)

Arm Type

Placebo Comparator

Arm Description

30 patients receive intraarticular injection with contrast media only

Intervention Type

Drug

Intervention Name(s)

Triamcort

Intervention Description

Fluoroscopic guided injection in the knee joint

Intervention Type

Drug

Intervention Name(s)

Platelet-rich-plasma

Intervention Type

Drug

Intervention Name(s)

Suplasyn1

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Pain assessment

Description

numeric rating scale (NRS) and WOMAC

Time Frame

up to 24 months after injection

Title

Magnetic Resonance imaging

Description

cartilage volume (ml)

Time Frame

up to 12 months after injection

Title

Magnetic Resonance imaging

Description

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

Time Frame

up to 12 months after injection

Secondary Outcome Measure Information:

Title

WOMAC score (stiffness, difficulty)

Description

Clinical outcome

Time Frame

up to 24 months after injection

Title

Tegner Activity Scale

Description

Clinical outcome

Time Frame

up to 24 months after injection

Title

Knee mobility and thigh circumference

Description

Clinical assessment, comparison to baseline

Time Frame

3 month after injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrea B Rosskopf, MD

Organizational Affiliation

Radiology University Hospital Balgrist

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Balgrist

City

Zurich

ZIP/Postal Code

8008

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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