Study in Patients With Knee Osteoarthritis Treated by Embolization Using NBGM200

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorNext Biomedical Co., Ltd.

About this trial

Study in patients with knee osteoarthritis treated by embolization using NBGM200

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Osteoarthritis proven by MR-imaging

Disqualifiers

Current local infection

Life expectancy less than 6 months

Trial design

Design model

Single group

Treatments tested in this trial

  • embolization therapy

    Device

    MSK embolization

Treatment groups

72 Participants
are divided into 1 treatment group
Group A: MSK embolizationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Knee Injury and Osteoarthritis Outcome score (KOOS-12)

Knee Injury and Osteoarthritis Outcome score (KOOS-12) is to evaluate the pain, function and quality of life. The total score ranges from 0 to 100, where higher scores indicate better outcomes.

Time frame
6 months post treatment

Secondary outcomes

1

Visual Analog Scale(VAS)

Visual Analog Scale(VAS) is to evaluate the pain from 0 to 10. Higher scores indicate worse outcomes, representing more severe pain

Time frame
6 months post treatment
2

Whole Organ Magnetic Resonance Imaging Score (WORMS)

Whole Organ Magnetic Resonance Imaging Score (WORMS) is a semi-quantitative scoring method for multi-feature, whole-organ evaluation of knee OA based on MRI. The total score ranges from 0 to 332, with higher scores indicating worse outcomes.

Time frame
6 months post treatment

Other outcomes

Sponsors and contacts

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