Geniculate Artery Embolization for the Treatment of Knee Pain (GAE)
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| ClinicalTrials.gov Identifier: NCT02850068 |
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Recruitment Status :
Completed
First Posted : July 29, 2016
Results First Posted : August 20, 2019
Last Update Posted : August 20, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoarthritis Of Knee | Device: Geniculate Artery Embolization | Not Applicable |
Purpose: The primary aims of this study are to determine if geniculate artery embolization (GAE) will reduce the severity of pain as well as global disability (resulting from the combination of pain, stiffness and difficulty performing daily activities) caused by knee OA and if it can be performed safely. The secondary aim is to determine if GAE can result in the decreased necessity for ongoing conservative OA therapies such as medication therapy and joint injections.
Participants: Twenty patients with knee osteoarthritis resulting in knee pain that is refractory to conservative therapies, who are not planning to undergo surgery within 6 months.
Procedures (methods): This will be an open label 24-month pilot study with a small population undergoing GAE 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, 1, 3 & 6 months. An MRI will be performed at the 1-month visit to detect a change in synovial vascularity and to exclude complication.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Geniculate Artery Embolization for the Treatment of Knee Pain Secondary to Osteoarthritis |
| Actual Study Start Date : | January 25, 2017 |
| Actual Primary Completion Date : | August 3, 2018 |
| Actual Study Completion Date : | August 3, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Geniculate Artery Embolization
Patients in this study will receive the geniculate artery embolization (GAE) procedure. The primary aims will be to determine if geniculate artery embolization (GAE) will reduce pain and disability (resulting from pain, stiffness and difficulty performing daily activities) caused by knee osteoarthritis (OA).
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Device: Geniculate Artery Embolization
Geniculate artery embolization (GAE) is a new procedure that is being used to reduce pain and disability (resulting from pain, stiffness and difficulty performing daily activities) caused by knee osteoarthritis (OA). Embolization is a procedure where physicians intentionally block the blood vessels to specific areas of the body to prevent blood flow to that region. By doing this, the decrease in blood flow will decrease the size of the area of interest. In this case, the goal is to decrease the size of inflammatory tissue around the knee, resulting in improvement of pain, stiffness and difficulty performing daily activities from OA.
Other Name: Embozene Microspheres |
- Patient Function (Units on a Scale) [ Time Frame: 6 months ]Western Ontario and McMaster University Osteoarthritis Index will be used to measure function. This is a score derived from a questionnaire in which the patient answers questions regarding rheumatic symptoms, stiffness, pain and how it affects the ability to function. Participants are asked to rate each question on a scale from 0 to 4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely) for the level of difficulty to complete each task. The categories are then totaled for an overall score out of 96. Higher values indicate greater levels of pain, stiffness, and functional limitations.
- Patient Pain (mm) [ Time Frame: 6 months ]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".
- Reduction in Medication (Percentage of Participants With a Reduction in Medication Therapy at Month 6) [ Time Frame: 6 months ]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 and simple statistics (percentage of participants with a reduction in medication therapy at month 6 months).
- Patient Complications (Number of Participants With Complications at Month 6) [ Time Frame: 6 months ]The number and description of complications, adverse events, or poor outcomes that are secondary to the GAE procedure, which will be summarized using counts and simple statistics (number of participants with complications at month 6)
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 obtained within the past 30 days.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02850068
| United States, North Carolina | |
| UNC Hospitals | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Virginia | |
| Vascular Institute of Virginia | |
| Woodbridge, Virginia, United States, 22193 | |
| Principal Investigator: | Ari Isaacson, MD | University of North Carolina, Chapel Hill |
Documents provided by University of North Carolina, Chapel Hill:
| Responsible Party: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT02850068 |
| Other Study ID Numbers: |
16-1969 |
| First Posted: | July 29, 2016 Key Record Dates |
| Results First Posted: | August 20, 2019 |
| Last Update Posted: | August 20, 2019 |
| Last Verified: | April 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
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Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |