Geniculate Artery Embolization for Knee Pain Secondary to Osteoarthritis (OA)
| Status: | Recruiting |
|---|---|
| Conditions: | Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 3/14/2019 |
| Start Date: | May 25, 2018 |
| End Date: | December 2019 |
| Contact: | Markeela Lipscomb |
| Email: | markeela_lipscomb@med.unc.edu |
| Phone: | 984-974-8157 |
Randomized Placebo-Controlled Single Blinded Study of Geniculate Artery Embolization for Knee Pain Secondary to Osteoarthritis
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.
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.
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.
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.
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 eGFR <60 obtained within the past 30 days.
We found this trial at
2
sites
Chapel Hill, North Carolina 27599
Principal Investigator: Ari Isaacson, MD
Phone: 919-966-4997
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