Trial Outcomes & Findings for Geniculate Artery Embolization for Knee Osteoarthritis (NCT NCT04951479)

NCT ID: NCT04951479

Last Updated: 2025-04-09

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: Baseline and 6 months from treatment
• Results posted on: 2025-04-09

Participant Flow

Participant milestones

Measure	Genicular Artery Embolization Arm This is the single arm of this cohort study. This cohort underwent the GAE procedure.
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Genicular Artery Embolization Arm This is the single arm of this cohort study. This cohort underwent the GAE procedure.
Overall Study Pre-existing Acute Knee Injury	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Gel-Bead Embolization n=10 Participants Gel-Bead embolization: Gelbead 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 Gelbeads 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.
Age, Continuous	53 years STANDARD_DEVIATION 11.8 • n=10 Participants
Sex: Female, Male Female	6 Participants n=10 Participants
Sex: Female, Male Male	4 Participants n=10 Participants
KOOS Pain Score	42 score on a scale n=10 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months from treatment

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

Outcome measures

Measure	Genicular Artery Embolization Arm n=10 Participants This is the single arm of this cohort study. This cohort underwent the GAE procedure.
Change in KOOS Pain Score	33 score on a scale Interval 22.0 to 47.0

SECONDARY outcome

Timeframe: Baseline and 6 months from treatment

Average change in the KOOS Function in Sport and Recreation (FSR). The KOOS FSR score runs from 0 (no symptoms) to 100 (worst symptoms).

Outcome measures

Measure	Genicular Artery Embolization Arm n=10 Participants This is the single arm of this cohort study. This cohort underwent the GAE procedure.
Change in Knee-related Functionality	39 score on a scale Interval 15.0 to 52.0

SECONDARY outcome

Timeframe: Baseline and 6 months from treatment

Average change in in the KOOS Quality of Life Scale (QoL) score. The KOOS QoL score runs from 0 (no symptoms) to 100 (worst symptoms). An increase in this value is considered improvement.

Outcome measures

Measure	Genicular Artery Embolization Arm n=10 Participants This is the single arm of this cohort study. This cohort underwent the GAE procedure.
Change in KOOS Quality of Life Scale	42 score on a scale Interval 17.0 to 50.0

SECONDARY outcome

Timeframe: Baseline and 6 months from treatment

Average change in 30-second chair stand test in number of chair stands. An increase in this value is considered improvement.

Outcome measures

Measure	Genicular Artery Embolization Arm n=10 Participants This is the single arm of this cohort study. This cohort underwent the GAE procedure.
Change in 30-second Chair Stand Test	4.5 chair stands Interval 2.3 to 10.3

SECONDARY outcome

Timeframe: Baseline and 6 months from treatment

Population: 6 minute walk test was not conducted due to feasibility issues. Protocol was amended to reflect exclusion of 6 minute walk test

distance walked (meters) in 6 minutes

Outcome measures

Outcome data not reported

Adverse Events

Genicular Artery Embolization Arm

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Genicular Artery Embolization Arm n=10 participants at risk This is the single arm of this cohort study. This cohort underwent the GAE procedure.
Skin and subcutaneous tissue disorders Transient Skin Discoloration of the Knee	30.0% 3/10 • Number of events 3 • 6 months
Skin and subcutaneous tissue disorders Allergic Reaction to Toradol	20.0% 2/10 • Number of events 2 • 6 months
Infections and infestations Fever	10.0% 1/10 • Number of events 1 • 6 months

Additional Information

Anish Ghodadra, MD

UPMC

Phone: 4126470104

Email: ghodadraa@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place