NCT03362957

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

Completed NA Results posted Last updated 22 March 2021

What this trial tests

NA trial testing Geniculate Artery Embolization in Osteo Arthritis Knee in 21 participants. Completed in 24 April 2020.

Timeline

25 May 2018

Primary endpoint
24 April 2020

24 April 2020

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	21
Start date	25 May 2018
Primary completion	24 April 2020
Estimated completion	24 April 2020
Sites	2 locations across United States

Drugs / interventions tested

• Geniculate Artery Embolization
• Sham Procedure — full drug profile →

Conditions studied

• Osteo Arthritis Knee — all drugs for Osteo Arthritis Knee →

Sponsor

University of North Carolina, Chapel Hill

Who can join

40 and older, any sex, with Osteo Arthritis Knee. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean WOMAC Scores at Month 6 Primary · 6 months following procedure

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 score (minimum 0; maximum 96). A higher score indicates more difficulty in each of the categories.

Group	Value	95% CI
GAE Procedure	29	± 25
Crossover Arm	26	± 31

Mean Patient Pain as Measured by VAS at Month 6 Primary · 6 months following procedure

The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain will be assessed at each of the patient's follow-up visits and used to measure the change from baseline (prior to the GAE procedure). The investigators will use this to measure if the patient's pain level decreases.

Group	Value	95% CI
GAE Procedure	20.3	± 25.6
Crossover Arm	19.2	± 35.3

Number of Participants With Reduction in Medication Secondary · 12 months following procedure

Reduction in the number or strength of previously initiated OA medical therapy (e.g. NSAIDs) at 6 months follow-up, which will be summarized using counts.

Group	Value	95% CI
GAE Procedure	5
Sham Procedure	0
Crossover Arm	1

Number of Patient With Complications Secondary · 6 months following procedure for the "GAE Procedure" and "Crossover Arm" Arms/Groups and 1 month following procedure for the "Sham Procedure" Arm/Group

The number and description of complications, adverse events, or poor outcomes (such as no improvement in pain) that are secondary to the GAE procedure, which will be summarized using counts.

Group	Value	95% CI
GAE Procedure	8
Sham Procedure	2
Crossover Arm	5

Mean WOMAC Scores at Month 1 Primary · 1 month following procedure

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 score (minimum 0; maximum 96). A higher score indicates more difficulty in each of the categories.

Group	Value	95% CI
GAE Procedure	34.7	± 24
Sham Procedure	65.9	± 11.3
Crossover Arm	46.3	± 29.6

Mean Patient Pain as Measured by VAS at Month 1 Primary · 1 month following procedure

The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain will be assessed at each of the patient's follow-up visits and used to measure the change from baseline (prior to the GAE procedure). The investigators will use this to measure if the patient's pain level decreases.

Group	Value	95% CI
GAE Procedure	30.5	± 27.9
Sham Procedure	78.4	± 10.2
Crossover Arm	39.8	± 31

Mean WOMAC Scores at Month 3 Primary · 3 months following procedure

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 score (minimum 0; maximum 96). A higher score indicates more difficulty in each of the categories.

Group	Value	95% CI
GAE Procedure	19.7	± 20.5
Crossover Arm	39.5	± 27.3

Mean Patient Pain as Measured by VAS at Month 3 Primary · 3 months following procedure

The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain will be assessed at each of the patient's follow-up visits and used to measure the change from baseline (prior to the GAE procedure). The investigators will use this to measure if the patient's pain level decreases.

Group	Value	95% CI
GAE Procedure	21.3	± 27.9
Crossover Arm	41.2	± 31.1

Adverse events — posted to ClinicalTrials.gov

Time frame: All adverse events were captured following the Sham procedure for 1 month and for the GAE procedure for the duration of the study, approximately 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GAE Procedure

Serious: 0/14 (0%)

Deaths: 0/14

Sham Procedure

Serious: 0/7 (0%)

Deaths: 0/7

Crossover Arm

Serious: 0/7 (0%)

Deaths: 0/7

Other adverse events (9 terms — click to expand)

Reaction	System	GAE Procedure	Sham Procedure	Crossover Arm
Purpura	Skin and subcutaneous tissue disorders	—	—	—
Knee pain	Musculoskeletal and connective tissue disorders	—	—	—
Nausea/Vomiting	General disorders	—	—	—
Hematoma	Skin and subcutaneous tissue disorders	—	—	—
Skin changes	Skin and subcutaneous tissue disorders	—	—	—
Skin Ischemia	Skin and subcutaneous tissue disorders	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—
Ecchymosis	Skin and subcutaneous tissue disorders	—	—	—
bleeding at access site	Blood and lymphatic system disorders	—	—	—

Data from ClinicalTrials.gov NCT03362957 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Genicular artery embolization for knee osteoarthritis: A systematic review of sham-controlled randomized trials.
   Milhem F, Takhman M, Elgendy MS, Zahra AA, et al · · 2025 · PMID 40766107 · DOI 10.1016/j.jor.2025.07.022