Trial Outcomes & Findings for Geniculate Artery Embolization for Knee Pain Secondary to Osteoarthritis (OA) (NCT NCT03362957)

Last Updated: 2021-03-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

21 participants

Primary outcome timeframe

6 months following procedure

Results posted on

2021-03-22

Participant Flow

All patients that received the sham procedure crossed over into the crossover arm.

Participant milestones

Participant milestones
Measure	GAE Procedure Patients will be randomized to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.	Sham Procedure First, Then GAE Procedure Patients will be randomized to a sham procedure. Sham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.
Overall Study STARTED	14	7
Overall Study Crossover to Receive GAE Procedure	0	7
Overall Study COMPLETED	14	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 6 months following procedure

Population: One participant was excluded from the GAE arm due to increased pain that resulted in additional medication and was excluded from the analysis. All sham participants crossed over to receive treatment after 1 month, thus no 6-month data available for this group. One crossover participant did not have WOMAC data available for the 6 month visit.

Outcome measures

Outcome measures
Measure	GAE Procedure n=13 Participants Patients will be randomized to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.	Sham Procedure Patients will be randomized to a sham procedure. Sham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram	Crossover Arm n=6 Participants If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.
Mean WOMAC Scores at Month 6	29 units on a scale Standard Deviation 25	—	26 units on a scale Standard Deviation 31

PRIMARY outcome

Timeframe: 6 months following procedure

Population: One participant was excluded from the GAE arm due to increased pain that resulted in additional medication and was excluded from the analysis. All sham participants crossed over to receive treatment after 1 month, thus no 6-month data available for this group. One patient in the crossover arm did not have VAS data available for the 6 month visit.

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.

Outcome measures

Outcome measures
Measure	GAE Procedure n=13 Participants Patients will be randomized to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.	Sham Procedure Patients will be randomized to a sham procedure. Sham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram	Crossover Arm n=6 Participants If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.
Mean Patient Pain as Measured by VAS at Month 6	20.3 mm Standard Deviation 25.6	—	19.2 mm Standard Deviation 35.3

PRIMARY outcome

Timeframe: 1 month following procedure

Population: One participant was excluded from the GAE arm due to increased pain that resulted in additional medication and was excluded from the analysis.

Outcome measures

Outcome measures
Measure	GAE Procedure n=13 Participants Patients will be randomized to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.	Sham Procedure n=7 Participants Patients will be randomized to a sham procedure. Sham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram	Crossover Arm n=7 Participants If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.
Mean WOMAC Scores at Month 1	34.7 units on a scale Standard Deviation 24	65.9 units on a scale Standard Deviation 11.3	46.3 units on a scale Standard Deviation 29.6

PRIMARY outcome

Timeframe: 1 month following procedure

Population: One participant was excluded from the GAE arm due to increased pain that resulted in additional medication and was excluded from the analysis.

Outcome measures

Outcome measures
Measure	GAE Procedure n=13 Participants Patients will be randomized to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.	Sham Procedure n=7 Participants Patients will be randomized to a sham procedure. Sham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram	Crossover Arm n=7 Participants If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.
Mean Patient Pain as Measured by VAS at Month 1	30.5 mm Standard Deviation 27.9	78.4 mm Standard Deviation 10.2	39.8 mm Standard Deviation 31

PRIMARY outcome

Timeframe: 3 months following procedure

Population: One participant was excluded from the GAE arm due to increased pain that resulted in additional medication and was excluded from the analysis. One additional participant in this arm did not have data available at the 3 month visit. All sham participants crossed over to receive treatment after 1 month, thus no 3-month data available for this group. One patient in the crossover arm did not have WOMAC data available for the 3 month visit.

Outcome measures

Outcome measures
Measure	GAE Procedure n=12 Participants Patients will be randomized to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.	Sham Procedure Patients will be randomized to a sham procedure. Sham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram	Crossover Arm n=6 Participants If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.
Mean WOMAC Scores at Month 3	19.7 units on a scale Standard Deviation 20.5	—	39.5 units on a scale Standard Deviation 27.3

PRIMARY outcome

Timeframe: 3 months following procedure

Outcome measures

Outcome measures
Measure	GAE Procedure n=12 Participants Patients will be randomized to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.	Sham Procedure Patients will be randomized to a sham procedure. Sham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram	Crossover Arm n=6 Participants If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.
Mean Patient Pain as Measured by VAS at Month 3	21.3 mm Standard Deviation 27.9	—	41.2 mm Standard Deviation 31.1

SECONDARY outcome

Timeframe: 12 months following procedure

Population: All participants in the sham arm crossed over 1 month after the sham procedure, thus no 6-month data available for this group.

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.

Outcome measures

Outcome measures
Measure	GAE Procedure n=14 Participants Patients will be randomized to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.	Sham Procedure Patients will be randomized to a sham procedure. Sham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram	Crossover Arm n=7 Participants If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.
Number of Participants With Reduction in Medication	5 Participants	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	GAE Procedure n=14 Participants Patients will be randomized to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.	Sham Procedure n=7 Participants Patients will be randomized to a sham procedure. Sham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram	Crossover Arm n=7 Participants If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.
Number of Patient With Complications	8 Participants	2 Participants	5 Participants

Adverse Events

GAE Procedure

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Sham Procedure

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Crossover 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

Other adverse events
Measure	GAE Procedure n=14 participants at risk Patients will be randomized to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.	Sham Procedure n=7 participants at risk Patients will be randomized to a sham procedure. Sham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram	Crossover Arm n=7 participants at risk If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.
Musculoskeletal and connective tissue disorders Knee pain	28.6% 4/14 • Number of events 4 • 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	0.00% 0/7 • 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	28.6% 2/7 • Number of events 2 • 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
Skin and subcutaneous tissue disorders Purpura	35.7% 5/14 • Number of events 5 • 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	0.00% 0/7 • 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	28.6% 2/7 • Number of events 2 • 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
General disorders Nausea/Vomiting	0.00% 0/14 • 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	14.3% 1/7 • Number of events 1 • 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	0.00% 0/7 • 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
Skin and subcutaneous tissue disorders Hematoma	0.00% 0/14 • 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	14.3% 1/7 • Number of events 1 • 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	0.00% 0/7 • 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
Skin and subcutaneous tissue disorders Skin changes	7.1% 1/14 • Number of events 1 • 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	0.00% 0/7 • 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	14.3% 1/7 • Number of events 1 • 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
Skin and subcutaneous tissue disorders Skin Ischemia	0.00% 0/14 • 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	0.00% 0/7 • 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	14.3% 1/7 • Number of events 1 • 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
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/14 • 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	0.00% 0/7 • 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	14.3% 1/7 • Number of events 1 • 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
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/14 • 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	14.3% 1/7 • Number of events 1 • 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	0.00% 0/7 • 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
Blood and lymphatic system disorders bleeding at access site	0.00% 0/14 • 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	14.3% 1/7 • Number of events 1 • 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	0.00% 0/7 • 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

Additional Information

Associate Director of Clinical Research Operations, Department of Radiology

University of North Carolina at Chapel Hill

Phone: 919-966-4997

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	GAE Procedure n=14 Participants Patients will be randomized to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.	Sham Procedure First, Then GAE Procedure n=7 Participants Patients will be randomized to a sham procedure. Sham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure Geniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.	Total n=21 Participants Total of all reporting groups
Age, Continuous	63.9 years STANDARD_DEVIATION 8.4 • n=14 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	62.9 years STANDARD_DEVIATION 7.1 • n=7 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	63.5 years STANDARD_DEVIATION 7.8 • n=21 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.
Sex: Female, Male Female	12 Participants n=14 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	6 Participants n=7 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	18 Participants n=21 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.
Sex: Female, Male Male	2 Participants n=14 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	1 Participants n=7 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	3 Participants n=21 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=14 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	0 Participants n=7 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	2 Participants n=21 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=14 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	6 Participants n=7 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	17 Participants n=21 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=14 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	1 Participants n=7 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	2 Participants n=21 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=14 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	0 Participants n=7 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	1 Participants n=21 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.
Race (NIH/OMB) Asian	0 Participants n=14 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	0 Participants n=7 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	0 Participants n=21 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	0 Participants n=7 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	0 Participants n=21 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.
Race (NIH/OMB) Black or African American	2 Participants n=14 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	3 Participants n=7 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	5 Participants n=21 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.
Race (NIH/OMB) White	11 Participants n=14 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	4 Participants n=7 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	15 Participants n=21 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.
Race (NIH/OMB) More than one race	0 Participants n=14 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	0 Participants n=7 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	0 Participants n=21 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	0 Participants n=7 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	0 Participants n=21 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.
Region of Enrollment United States	14 Participants n=14 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	7 Participants n=7 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.	21 Participants n=21 Participants • All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.
WOMAC Baseline for study	64.9 units on a scale STANDARD_DEVIATION 16.6 • n=14 Participants • All patients in the sham arm crossed over to receive the GAE procedure. Their baseline scores following the sham procedure are summarized in a separate row. Participants that had the GAE procedure to start are not crossed over.	70.9 units on a scale STANDARD_DEVIATION 13.1 • n=7 Participants • All patients in the sham arm crossed over to receive the GAE procedure. Their baseline scores following the sham procedure are summarized in a separate row. Participants that had the GAE procedure to start are not crossed over.	66.6 units on a scale STANDARD_DEVIATION 14.4 • n=21 Participants • All patients in the sham arm crossed over to receive the GAE procedure. Their baseline scores following the sham procedure are summarized in a separate row. Participants that had the GAE procedure to start are not crossed over.
WOMAC Baseline Following Sham Procedure	—	65.9 units on a scale STANDARD_DEVIATION 11.3 • n=7 Participants • All patients in the sham arm crossed over to receive the GAE procedure. Their baseline scores following the sham procedure are summarized in a separate row. Participants that had the GAE procedure to start are not crossed over.	65.9 units on a scale STANDARD_DEVIATION 11.3 • n=7 Participants • All patients in the sham arm crossed over to receive the GAE procedure. Their baseline scores following the sham procedure are summarized in a separate row. Participants that had the GAE procedure to start are not crossed over.
VAS Baseline	13.9 mm STANDARD_DEVIATION 3.1 • n=14 Participants • All patients in the sham arm crossed over to receive the GAE procedure. Their baseline scores following the sham procedure are summarized in a separate row. Participants that had the GAE procedure to start are not crossed over.	15.4 mm STANDARD_DEVIATION 3.5 • n=7 Participants • All patients in the sham arm crossed over to receive the GAE procedure. Their baseline scores following the sham procedure are summarized in a separate row. Participants that had the GAE procedure to start are not crossed over.	14.3 mm STANDARD_DEVIATION 3.1 • n=21 Participants • All patients in the sham arm crossed over to receive the GAE procedure. Their baseline scores following the sham procedure are summarized in a separate row. Participants that had the GAE procedure to start are not crossed over.
VAS baseline following sham procedure	—	14 mm STANDARD_DEVIATION 2.7 • n=7 Participants • All patients in the sham arm crossed over to receive the GAE procedure. Their baseline scores following the sham procedure are summarized in a separate row. Participants that had the GAE procedure to start are not crossed over.	14 mm STANDARD_DEVIATION 2.7 • n=7 Participants • All patients in the sham arm crossed over to receive the GAE procedure. Their baseline scores following the sham procedure are summarized in a separate row. Participants that had the GAE procedure to start are not crossed over.