Health TrialsbyHealthPanel

Randomized Controlled Study Evaluating Genicular Artery Embolization Against Intra-Articular Corticosteroid Knee Injection for Osteoarthritic Knee Pain

ConditionKnee Osteoarthritis (Knee OA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorNorth American Science Associates Ltd.

About this trial

Multi-center, prospective, randomized trial of GAE using Nexsphere-F against steroid injection

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient has localized knee pain

Must be an appropriate candidate for arterial vascular access procedure

Disqualifiers

Known sensitivity or allergy to implant materials

Unable or unwilling to comply with study requirements

Trial design

Design model

Crossover

Treatments tested in this trial

  • genicular artery embolization

    Device

    genicular artery embolization

  • Corticosteroid Injection

    Drug

    Corticosteroid Injection

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: Device: GAEExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Changes in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Scale ranges from 0 to 96 with higher scores equating to greater pain, stiffness and difficulty with activities of daily living.

Time frame
6 and 12-month post treatment
2

Serious Adverse Events (SAE)

Time frame
Treatment, 1,3,6,9 and 12-month post treatment

Secondary outcomes

1

WOMAC total score

Changes in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Scale ranges from 0 to 96 with higher scores equating to greater pain, stiffness and difficulty with activities of daily living

Time frame
9 month post treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

North American Science Associates Ltd.

Lead sponsor

Next Biomedical Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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