Geniculate Artery Embolization for Knee Osteoarthritis

NCT04951479 | Completed Results DMC FDA Device

• 1 other identifier: STUDY19010266
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to perform a prospective case series to determine efficacy of transcatheter arterial embolization in treating knee osteoarthritis related pain, improving functionality, and reducing opiate usage in patients with mild to moderate knee osteoarthritis who have failed conservative management. The Gel-Bead embolization particles will be used to perform geniculate artery embolization (GAE) for the purposes of treatment of osteoarthritis-related knee pain.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in KOOS Pain Score

  Change in pain score of at least 10 points based on the KOOS Pain questionnaire. The KOOS Pain score runs from 0 (no pain) to 100 (worst pain). The change in KOOS pain score will be the primary outcome measure. Minimum score is 0 and maximum is 100. higher score is better outcome

  Baseline and 6 months from treatment

Secondary Outcomes (4)

• Change in Knee-related Functionality

  Baseline and 6 months from treatment

• Change in KOOS Quality of Life Scale

  Baseline and 6 months from treatment

• Change in 30-second Chair Stand Test

  Baseline and 6 months from treatment

• 6-minute Walk Test

  Baseline and 6 months from treatment

Study Arms (1)

Gel-Bead Embolization

EXPERIMENTAL

This is the arm undergoing the genicular artery embolization procedure

Device: Gel-Bead embolization

Interventions

Gel-Bead embolization DEVICE

OptiSphere is FDA approved for the embolization of hypervascular tumors. The product is crosslinked with glutaraldehyde, which improves the mechanical strength of the spheres and provides controlled degradation after implant. The spherical shape provides smooth embolic delivery and even, predictable distribution. In this study the Optispheres will be used for Geniculate artery embolization (GAE) which is a minimally-invasive procedure that has historically been performed for treatment of patients with recurrent knee hemarthrosis. Embolization is a procedure in which material is used to block small blood vessels. Angiogenesis, or growth of new vessels, has been implicated in the initiation and maintenance of joint inflammation. GAE has been applied to patients with moderate osteoarthritis-related pain refractory to maximal medical management with preliminary studies demonstrating a reduction in patient pain.

Gel-Bead Embolization

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between ages 18 and 75 with moderate/severe knee pain secondary to primary osteoarthritis. Moderate/severe pain will be defined as pain 30 mm to 100 mm on the Visual Analog Pain Scale (where 0 denotes 'no pain' and 100 mm denotes worst pain imaginable')
• Grade 1, 2, or 3 osteoarthritis on the Kellgren-Lawrence grading scale on knee x-ray in the last 6 months
• Pain must be refractory to 3 months of medical management (which may include a combination of oral analgesics, intraarticular steroids, viscosupplementation, opioid therapy, etc)
• Patients willing and able to consent to the study

You may not qualify if:

• Kidney dysfunction defined as an estimated GFR \< 60 mL/min
• Acute knee injury
• Current local infection
• Prior ipsilateral knee replacement surgery
• Infectious or inflammatory arthritis
• History of contrast allergy resulting in anaphylaxis
• INR (International Normalization Ratio) \> 1.6
• Platelets \< 50,000
• Significant atherosclerosis that would limit angiography
• Active malignancy
• Active pregnancy
• Appropriate candidate for knee replacement surgery determined by clinical and physical examination
• Recent within 3 months, or active cigarette user

Sponsors & Collaborators

• Anish Ghodadra: lead

Study Sites (1)

UPMC Shadyside

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Anish Ghodadra, MD
• Organization: UPMC

ghodadraa@upmc.edu

4126470104

Study Officials

• Anish Ghodadra, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 6, 2021
• Study Start: November 3, 2021
• Primary Completion: October 26, 2023
• Study Completion: October 26, 2023
• Last Updated: April 9, 2025
• Results First Posted: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)