Clinical trial NCT03362957: Geniculate Artery Embolization for Knee Pain Secondary to Osteoarthritis (OA)
Official title: Randomized Placebo-Controlled Single Blinded Study of Geniculate Artery Embolization for Knee Pain Secondary to Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: embolization
vascular
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2017-12-05
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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. After Institutional Review Board (IRB) approval of a written informed consent and over, approximately a 24 month duration, N=21 subjects will be recruited. Only subjects ≥ 40 years will be screened for study recruitment. Subjects will be randomized in a 2:1 ratio of GAE:Placebo and will be blinded from study treatment (see flow chart below). 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. This second procedure should be shorter than a complete angiogram and embolization, as the detailed angiogram will not need to be repeated, and therefore both arms will have similar total radiation dose.

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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Mean WOMAC Scores at Month 6
timeFrame: 6 months following procedure
measure: Mean Patient Pain as Measured by VAS at Month 6
timeFrame: 6 months following procedure
measure: Mean WOMAC Scores at Month 1
timeFrame: 1 month following procedure
measure: Mean Patient Pain as Measured by VAS at Month 1
timeFrame: 1 month following procedure
measure: Mean WOMAC Scores at Month 3
timeFrame: 3 months following procedure
measure: Mean Patient Pain as Measured by VAS at Month 3
timeFrame: 3 months following procedure
Secondary outcomes:
measure: Number of Participants With Reduction in Medication
timeFrame: 12 months following procedure
Other outcomes:
measure: Number of Patient With Complications
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
Locations:
city: Chapel Hill
country: United States
facility: UNC Hospitals
state: North Carolina
city: Woodbridge
country: United States
facility: Vascular Institute of Virginia
state: Virginia
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Ari Isaacson, MD
role: PRINCIPAL_INVESTIGATOR
References: