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Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Embosphere Microspheres
Sponsored by
Shivank Bhatia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject has signed informed consent
  • Subject is age 40-80
  • Subject is able to have an MRI

  • Minimum of prior 12 weeks of failed response to conservative therapy for knee osteoarthritis, which may include one or more of:

    a) Oral or topical NSAIDS, opioid medications, intra-articular injection of glucocorticoids or hyaluronic acid, physical therapy.

  • Localized tenderness in anterior knee area
  • Kellgren-Lawrence grade 1, 2, or 3 as assessed by weight-bearing knee radiographs
  • Synovitis present as assessed by WORMS
  • VAS >50 mm
  • WOMAC score >30

Exclusion Criteria:

  • Rheumatoid arthritis
  • Local infection of the target knee(s)
  • Kellgren-Lawrence grade >3
  • Osteonecrosis evident by MRI
  • Prior knee arthroplasty
  • Allergy to iodinated contrast agents that cannot be managed by prophylaxis
  • Hypersensitivity to gelatin products
  • Any known condition that limits catheter-based intervention or is a contraindication to embolization
  • Active malignancy other than non-melanomatous skin cancer
  • Subject is pregnant, breastfeeding, or pre-menopausal and intending to become pregnant
  • Any other condition related to the subject's health and wellbeing deemed exclusionary in the opinion of the investigator

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Embosphere Microspheres group

Arm Description

Participants in this group who are receiving standard of care (SOC) embolization surgery for the treatment of moderate to severe knee osteoarthritis will receive the Embospheres Microspheres during scheduled SOC surgery.

Outcomes

Primary Outcome Measures

Change in knee pain as assessed by the WOMAC
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain index assesses participants' pain on a scale ranging from 0 (none) to 4 (extreme). The pain subscale consists of 5 items and total scores can range from 0-20, with larger scores indicating greater pain.
Incidence of treatment related adverse events
Procedure-related and target knee osteoarthritis-related adverse events as assessed by treating physician

Secondary Outcome Measures

Change in knee pain as assessed by VAS
Visual Analog Scale (VAS) has a total score ranging from 0-10 with the higher score indicating greater pain
Change in knee pain
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain index assesses participants' pain on a scale ranging from 0 (none) to 4 (extreme). The pain subscale consists of 5 items and total scores can range from 0-20, with larger scores indicating greater pain.
Incidence of adverse events
Procedure-related and target knee osteoarthritis-related adverse events as assessed by treating physician
WORMS Score for Synovitis
Whole-Organ Magnetic Resonance Imaging Score (WORMS) has a score ranging from zero representing no knee problems and 332 representing knee problems
Kellgren-Lawrence Grade
As assessed by X-Ray. Radiograph imaging graded on scale 1 (no arthritis) to 4 (severe arthritis)

Full Information

First Posted
November 1, 2021
Last Updated
April 24, 2023
Sponsor
Shivank Bhatia
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1. Study Identification

Unique Protocol Identification Number
NCT05112926
Brief Title
Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis
Official Title
Prospective, Single Arm Investigation to Assess Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2022 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shivank Bhatia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research study is to evaluate the effectiveness and safety of a permanent embolic (Embosphere Microspheres) for embolization of the geniculate artery for the treatment of moderate to severe knee osteoarthritis.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Embosphere Microspheres group
Arm Type
Experimental
Arm Description
Participants in this group who are receiving standard of care (SOC) embolization surgery for the treatment of moderate to severe knee osteoarthritis will receive the Embospheres Microspheres during scheduled SOC surgery.
Intervention Type
Device
Intervention Name(s)
Embosphere Microspheres
Intervention Description
Embosphere Microspheres are 100-300μm small, compressible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin used for embolization of geniculate artery.
Primary Outcome Measure Information:
Title
Change in knee pain as assessed by the WOMAC
Description
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain index assesses participants' pain on a scale ranging from 0 (none) to 4 (extreme). The pain subscale consists of 5 items and total scores can range from 0-20, with larger scores indicating greater pain.
Time Frame
Baseline, 24 Weeks (Post Embolization Surgery)
Title
Incidence of treatment related adverse events
Description
Procedure-related and target knee osteoarthritis-related adverse events as assessed by treating physician
Time Frame
Up to 4 weeks (Post Embolization Surgery)
Secondary Outcome Measure Information:
Title
Change in knee pain as assessed by VAS
Description
Visual Analog Scale (VAS) has a total score ranging from 0-10 with the higher score indicating greater pain
Time Frame
Baseline, up to 52 weeks (Post Embolization Surgery)
Title
Change in knee pain
Description
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain index assesses participants' pain on a scale ranging from 0 (none) to 4 (extreme). The pain subscale consists of 5 items and total scores can range from 0-20, with larger scores indicating greater pain.
Time Frame
Baseline, up to 52 weeks (Post Embolization Surgery)
Title
Incidence of adverse events
Description
Procedure-related and target knee osteoarthritis-related adverse events as assessed by treating physician
Time Frame
Up to 52 weeks (Post Embolization Surgery)
Title
WORMS Score for Synovitis
Description
Whole-Organ Magnetic Resonance Imaging Score (WORMS) has a score ranging from zero representing no knee problems and 332 representing knee problems
Time Frame
Baseline, up to 52 weeks (Post Embolization Surgery)
Title
Kellgren-Lawrence Grade
Description
As assessed by X-Ray. Radiograph imaging graded on scale 1 (no arthritis) to 4 (severe arthritis)
Time Frame
Baseline, up to 52 weeks (Post Embolization Surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has signed informed consent Subject is age 40-80 Subject is able to have an MRI Minimum of prior 12 weeks of failed response to conservative therapy for knee osteoarthritis, which may include one or more of: a) Oral or topical NSAIDS, opioid medications, intra-articular injection of glucocorticoids or hyaluronic acid, physical therapy. Localized tenderness in anterior knee area Kellgren-Lawrence grade 1, 2, or 3 as assessed by weight-bearing knee radiographs Synovitis present as assessed by WORMS VAS >50 mm WOMAC score >30 Exclusion Criteria: Rheumatoid arthritis Local infection of the target knee(s) Kellgren-Lawrence grade >3 Osteonecrosis evident by MRI Prior knee arthroplasty Allergy to iodinated contrast agents that cannot be managed by prophylaxis Hypersensitivity to gelatin products Any known condition that limits catheter-based intervention or is a contraindication to embolization Active malignancy other than non-melanomatous skin cancer Subject is pregnant, breastfeeding, or pre-menopausal and intending to become pregnant Any other condition related to the subject's health and wellbeing deemed exclusionary in the opinion of the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lia Quezada
Phone
305-243-2210
Email
Lquezada@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shivank Bhatia
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lia Quezada
Phone
305-243-2210
Email
Lquezada@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Shivank Bhatia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis

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