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

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ClinicalTrials.gov Identifier: NCT03362957
Recruitment Status : Completed
First Posted : December 5, 2017
Results First Posted : March 15, 2021
Last Update Posted : March 22, 2021
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Osteo Arthritis Knee
Interventions Device: Geniculate Artery Embolization
Diagnostic Test: Sham Procedure
Enrollment 21
Recruitment Details  
Pre-assignment Details All patients that received the sham procedure crossed over into the crossover arm.
Arm/Group Title GAE Procedure Sham Procedure First, Then GAE Procedure
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 14 7
Crossover to Receive GAE Procedure 0 7
Completed 14 7
Not Completed 0 0
Arm/Group Title GAE Procedure Sham Procedure First, Then GAE Procedure Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 14 7 21
Hide Baseline Analysis Population Description
All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants are the same baseline characteristics except the VAS and WOMAC where they had new baseline scores following the sham procedure.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 7 participants 21 participants
63.9  (8.4) 62.9  (7.1) 63.5  (7.8)
[1]
Measure Analysis Population Description: 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   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 7 participants 21 participants
Female
12
  85.7%
6
  85.7%
18
  85.7%
Male
2
  14.3%
1
  14.3%
3
  14.3%
[1]
Measure Analysis Population Description: 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)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 7 participants 21 participants
Hispanic or Latino
2
  14.3%
0
   0.0%
2
   9.5%
Not Hispanic or Latino
11
  78.6%
6
  85.7%
17
  81.0%
Unknown or Not Reported
1
   7.1%
1
  14.3%
2
   9.5%
[1]
Measure Analysis Population Description: 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)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 7 participants 21 participants
American Indian or Alaska Native
1
   7.1%
0
   0.0%
1
   4.8%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  14.3%
3
  42.9%
5
  23.8%
White
11
  78.6%
4
  57.1%
15
  71.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: 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   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 14 participants 7 participants 21 participants
14
 100.0%
7
 100.0%
21
 100.0%
[1]
Measure Analysis Population Description: 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   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Baseline for study Number Analyzed 14 participants 7 participants 21 participants
64.9  (16.6) 70.9  (13.1) 66.6  (14.4)
Baseline Following Sham Procedure Number Analyzed 0 participants 7 participants 7 participants
65.9  (11.3) 65.9  (11.3)
[1]
Measure Description: 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.
[2]
Measure Analysis Population Description: 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   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Mm
Baseline Number Analyzed 14 participants 7 participants 21 participants
13.9  (3.1) 15.4  (3.5) 14.3  (3.1)
baseline following sham procedure Number Analyzed 0 participants 7 participants 7 participants
14  (2.7) 14  (2.7)
[1]
Measure Description: 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.
[2]
Measure Analysis Population Description: 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.
1.Primary Outcome
Title Mean WOMAC Scores at Month 6
Hide Description 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.
Time Frame 6 months following procedure
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GAE Procedure Sham Procedure Crossover Arm
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 13 0 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
29  (25) 26  (31)
2.Primary Outcome
Title Mean Patient Pain as Measured by VAS at Month 6
Hide Description 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.
Time Frame 6 months following procedure
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GAE Procedure Sham Procedure Crossover Arm
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 13 0 6
Mean (Standard Deviation)
Unit of Measure: mm
20.3  (25.6) 19.2  (35.3)
3.Primary Outcome
Title Mean WOMAC Scores at Month 1
Hide Description 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.
Time Frame 1 month following procedure
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded from the GAE arm due to increased pain that resulted in additional medication and was excluded from the analysis.
Arm/Group Title GAE Procedure Sham Procedure Crossover Arm
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 13 7 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
34.7  (24) 65.9  (11.3) 46.3  (29.6)
4.Primary Outcome
Title Mean Patient Pain as Measured by VAS at Month 1
Hide Description 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.
Time Frame 1 month following procedure
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was excluded from the GAE arm due to increased pain that resulted in additional medication and was excluded from the analysis.
Arm/Group Title GAE Procedure Sham Procedure Crossover Arm
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 13 7 7
Mean (Standard Deviation)
Unit of Measure: mm
30.5  (27.9) 78.4  (10.2) 39.8  (31)
5.Primary Outcome
Title Mean WOMAC Scores at Month 3
Hide Description 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.
Time Frame 3 months following procedure
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GAE Procedure Sham Procedure Crossover Arm
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 12 0 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
19.7  (20.5) 39.5  (27.3)
6.Primary Outcome
Title Mean Patient Pain as Measured by VAS at Month 3
Hide Description 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.
Time Frame 3 months following procedure
Hide Outcome Measure Data
Hide Analysis Population Description
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 VAS data available for the 3 month visit.
Arm/Group Title GAE Procedure Sham Procedure Crossover Arm
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 12 0 6
Mean (Standard Deviation)
Unit of Measure: mm
21.3  (27.9) 41.2  (31.1)
7.Secondary Outcome
Title Number of Participants With Reduction in Medication
Hide Description 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.
Time Frame 12 months following procedure
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the sham arm crossed over 1 month after the sham procedure, thus no 6-month data available for this group.
Arm/Group Title GAE Procedure Sham Procedure Crossover Arm
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 14 0 7
Measure Type: Count of Participants
Unit of Measure: Participants
5
  35.7%
0
1
  14.3%
8.Other Pre-specified Outcome
Title Number of Patient With Complications
Hide Description 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.
Time Frame 6 months following procedure for the "GAE Procedure" and "Crossover Arm" Arms/Groups and 1 month following procedure for the "Sham Procedure" Arm/Group
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAE Procedure Sham Procedure Crossover Arm
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 14 7 7
Measure Type: Count of Participants
Unit of Measure: Participants
8
  57.1%
2
  28.6%
5
  71.4%
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
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GAE Procedure Sham Procedure Crossover Arm
Hide Arm/Group Description

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.

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.

All-Cause Mortality
GAE Procedure Sham Procedure Crossover Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)      0/7 (0.00%)      0/7 (0.00%)    
Hide Serious Adverse Events
GAE Procedure Sham Procedure Crossover Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/7 (0.00%)      0/7 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
GAE Procedure Sham Procedure Crossover Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/14 (57.14%)      2/7 (28.57%)      5/7 (71.43%)    
Blood and lymphatic system disorders       
bleeding at access site *  0/14 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
General disorders       
Nausea/Vomiting *  0/14 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Knee pain *  4/14 (28.57%)  4 0/7 (0.00%)  0 2/7 (28.57%)  2
Skin and subcutaneous tissue disorders       
Purpura *  5/14 (35.71%)  5 0/7 (0.00%)  0 2/7 (28.57%)  2
Hematoma *  0/14 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Skin changes *  1/14 (7.14%)  1 0/7 (0.00%)  0 1/7 (14.29%)  1
Skin Ischemia *  0/14 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Pruritus *  0/14 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Ecchymosis *  0/14 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Associate Director of Clinical Research Operations, Department of Radiology
Organization: University of North Carolina at Chapel Hill
Phone: 919-966-4997
EMail: rad_research@med.unc.edu
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03362957    
Other Study ID Numbers: 17-2701
First Submitted: November 29, 2017
First Posted: December 5, 2017
Results First Submitted: January 27, 2021
Results First Posted: March 15, 2021
Last Update Posted: March 22, 2021