NCT02776514

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

February 7, 2022

Status Verified

January 1, 2022

Enrollment Period

4.8 years

First QC Date

February 18, 2016

Last Update Submit

January 27, 2022

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (3)

  • Pain assessment

    numeric rating scale (NRS) and WOMAC

    up to 24 months after injection

  • Magnetic Resonance imaging

    cartilage volume (ml)

    up to 12 months after injection

  • Magnetic Resonance imaging

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

    up to 12 months after injection

Secondary Outcomes (3)

  • WOMAC score (stiffness, difficulty)

    up to 24 months after injection

  • Tegner Activity Scale

    up to 24 months after injection

  • Knee mobility and thigh circumference

    3 month after injection

Study Arms (4)

Triamcort (1 ml, 40 mg/ml)

ACTIVE COMPARATOR

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

Drug: Triamcort

Platelet-rich-plasma (PRP 3 ml)

ACTIVE COMPARATOR

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

Drug: Platelet-rich-plasma

Suplasyn1-shot (60 mg/ ml)

ACTIVE COMPARATOR

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

Drug: Suplasyn1

Placebo (Iopamiro 200)

PLACEBO COMPARATOR

30 patients receive intraarticular injection with contrast media only

Drug: Placebo

Interventions

TriamcortDRUG

Fluoroscopic guided injection in the knee joint

Triamcort (1 ml, 40 mg/ml)
Platelet-rich-plasmaDRUG
Platelet-rich-plasma (PRP 3 ml)
Suplasyn1DRUG
Suplasyn1-shot (60 mg/ ml)
PlaceboDRUG
Placebo (Iopamiro 200)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Balgrist

Zurich, 8008, Switzerland

Location

Related Publications (2)

  • Tschopp M, Pfirrmann CWA, Brunner F, Fucentese SF, Galley J, Stern C, Sutter R, Catanzaro S, Kuhne N, Rosskopf AB. Morphological and Quantitative Parametric MRI Follow-up of Cartilage Changes Before and After Intra-articular Injection Therapy in Patients With Mild to Moderate Knee Osteoarthritis: A Randomized, Placebo-Controlled Trial. Invest Radiol. 2024 Sep 1;59(9):646-655. doi: 10.1097/RLI.0000000000001067. Epub 2024 Feb 28.

    PMID: 38421679DERIVED

  • Tschopp M, Pfirrmann CWA, Fucentese SF, Brunner F, Catanzaro S, Kuhne N, Zwyssig I, Sutter R, Gotschi T, Tanadini M, Rosskopf AB. A Randomized Trial of Intra-articular Injection Therapy for Knee Osteoarthritis. Invest Radiol. 2023 May 1;58(5):355-362. doi: 10.1097/RLI.0000000000000942. Epub 2022 Dec 27.

    PMID: 36728848DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Andrea B Rosskopf, MD

    Radiology University Hospital Balgrist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2016

First Posted

May 18, 2016

Study Start

February 1, 2016

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

February 7, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)