Osteoarthritis Of Knee Clinical Trial
— GAEOfficial title:
Geniculate Artery Embolization for the Treatment of Knee Pain Secondary to Osteoarthritis
NCT number | NCT02850068 |
Other study ID # | 16-1969 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 25, 2017 |
Est. completion date | August 3, 2018 |
Verified date | April 2019 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is to test a new treatment method, geniculate artery embolization (GAE), to reduce the severity of pain and disability caused by knee osteoarthritis.
Status | Completed |
Enrollment | 20 |
Est. completion date | August 3, 2018 |
Est. primary completion date | August 3, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | UNC Hospitals | Chapel Hill | North Carolina |
United States | Vascular Institute of Virginia | Woodbridge | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient Complications (Number of Participants With Complications at Month 6) | 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) | 6 months | |
Primary | Patient Function (Units on a Scale) | 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. | 6 months | |
Primary | Patient Pain (mm) | 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". | 6 months | |
Secondary | Reduction in Medication (Percentage of Participants With a Reduction in Medication Therapy at Month 6) | 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). | 6 months |
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