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NCT03362957 · ClinicalTrials.gov registry record · NA

Geniculate Artery Embolization for Knee Pain Secondary to Osteoarthritis (OA)

A NA study, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
NA
Development phase
21
Enrollment target

NCT03362957: Completed NA study, sponsored by University of North Carolina, Chapel Hill.

NCT03362957 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03362957, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
NA
Development phase
21 participants
Enrollment target

Study Summary

Purpose: To evaluate embolization as a treatment for OA related knee pain versus placebo to demonstrate the actual effect of embolization on pain and disability. Participants: There will be 21 subjects enrolled over the age 40 with knee pain secondary to arthritis. Procedures (methods): This will be a single-blinded randomized-controlled study of GAE versus placebo in a small population with knee pain secondary to arthritis to determine safety and efficacy. Clinical procedures and evaluations will consist of a preoperative screening assessment to determine if the potential study subject meets the inclusion and exclusion criteria, enrollment, surgical procedure for geniculate artery embolization, and follow-up visits at 24 hours, 2 weeks, 1, 3, 6, \& 12 months. An MRI may be performed after the 1-month visit.

Primary Outcome

Western Ontario and McMaster University Osteoarthritis Index (WOMAC) will be used to measure function. This is a score derived from a questionnaire in which the patient answers questions regarding rheumatic symptoms in the subcategories of pain (5 items), stiffness (2 items), and physical function (17 items). Individuals select the level of difficulty they have performing various tasks using a 5 point Likert scale (0=None, 1=Slightly, 3=Very, 4=Extremely). Then, results are scored with a total s

Interventions

  • DEVICE Geniculate Artery Embolization
  • DIAGNOSTIC_TEST Sham Procedure

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2018-05-25
Est. Completion 2020-04-24
Phase NA

What the finished NCT03362957 record still lists

NCT03362957 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Geniculate Artery Embolization is the first listed.

NCT03362957 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03362957 about?

NCT03362957 is a clinical study titled "Geniculate Artery Embolization for Knee Pain Secondary to Osteoarthritis (OA)". Purpose: To evaluate embolization as a treatment for OA related knee pain versus placebo to demonstrate the actual effect of embolization on pain and disability. Participants: There will be 21 subjects enrolled over the age 40 with knee pain secondary to arthritis. Procedures (methods): This will ...

What is the current status of trial NCT03362957?

This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2018-05-25. Estimated completion is 2020-04-24.

What interventions are being tested in trial NCT03362957?

The interventions under investigation include: Geniculate Artery Embolization (DEVICE), Sham Procedure (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT03362957?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03362957's enrollment target sits among peer trials

21 1762nd of 2000 higher than 233 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03362957, the US trial registry maintained by the National Library of Medicine. NCT03362957 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.