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

NCT03362957 | Completed Results FDA Device

• 1 other identifier: 17-2701
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Osteo Arthritis Knee

Keywords

embolization; vascular

Outcome Measures

Primary Outcomes (6)

• Mean WOMAC Scores at Month 6

  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.

  6 months following procedure

• Mean Patient Pain as Measured by VAS at Month 6

  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.

  6 months following procedure

• Mean WOMAC Scores at Month 1

  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.

  1 month following procedure

• Mean Patient Pain as Measured by VAS at Month 1

  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.

  1 month following procedure

• Mean WOMAC Scores at Month 3

  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.

  3 months following procedure

• Mean Patient Pain as Measured by VAS at Month 3

  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.

  3 months following procedure

Secondary Outcomes (1)

• Number of Participants With Reduction in Medication

  12 months following procedure

Other Outcomes (1)

• Number of Patient With Complications

  6 months following procedure for the "GAE Procedure" and "Crossover Arm" Arms/Groups and 1 month following procedure for the "Sham Procedure" Arm/Group

Study Arms (3)

GAE Procedure

EXPERIMENTAL

Patients will be randomized to receive the Geniculate Artery Embolization Procedure

Device: Geniculate Artery Embolization

Sham Procedure

SHAM COMPARATOR

Patients will be randomized to a sham procedure.

Diagnostic Test: Sham Procedure

Crossover Arm

EXPERIMENTAL

If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure

Device: Geniculate Artery Embolization

Interventions

Geniculate Artery Embolization DEVICE

Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.

Crossover Arm; GAE Procedure

Sham Procedure DIAGNOSTIC_TEST

Patients will receive a sham procedure, which will include a diagnostic angiogram

Sham Procedure

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe knee pain (visual analog scale (VAS) \> 50 mm), and Pain refractory to at least 3 months\* of conservative therapies (anti- inflammatory drugs, or physical therapy, or muscle strengthening, or intra- articular injections), and Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee.

You may not qualify if:

• Current local infection, or Life expectancy less than 6 months, or Known advanced atherosclerosis, or Rheumatoid or infectious arthritis, or Prior knee surgery, or Uncorrectable coagulopathy including international normalized ratio (INR) \> 2.5 or platelets \< 30,000, or Iodine allergy resulting in anaphylaxis, or Renal dysfunction as defined by serum creatinine \>1.6 dl/mg or estimated glomerular filtration rate (eGFR) \<60 obtained within the past 30 days.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Medtronic: collaborator

Study Sites (2)

UNC Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

Vascular Institute of Virginia

Woodbridge, Virginia, 22193, United States

Location

Results Point of Contact

• Title: Associate Director of Clinical Research Operations, Department of Radiology
• Organization: University of North Carolina at Chapel Hill

rad_research@med.unc.edu

919-966-4997

Study Officials

• Ari Isaacson, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. The placebo procedure will be a diagnostic angiogram of the knee, without embolization. Appropriate measures will be taken to ensure patients and nursing staff caring for the patient are blinded to assignment. Each patient will be told at the time of recruitment that they may be randomly assigned to sham, but if after 1 month they have not had symptom improvement, their assigned procedure would be revealed and, if they had undergone a sham procedure, they will be allowed to proceed with embolization.

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 5, 2017
• Study Start: May 25, 2018
• Primary Completion: April 24, 2020
• Study Completion: April 24, 2020
• Last Updated: March 22, 2021
• Results First Posted: March 15, 2021

Record last verified: 2021-03

Locations

US (2)