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Geniculate Artery Embolization for Osteoarthritis

Study Purpose

The need for exploration of more definitive and cost effective non-arthroplasty treatments of osteoarthritis (OA) has been demonstrated by the orthopedic and health economic research. Embolotherapy of neovessels associated with OA joints has been shown to be promising in patients with knee OA. There is a need for level one evidence drawn from randomized clinical trials to prove the safety, feasibility and efficacy of knee embolotherapy compared to standard of care. This randomized pilot study will assign 10 patients with mild-moderate OA to undergo geniculate artery embolization plus standard of care (defined in this study as: physical therapy and oral anti-inflammatory medications, with a maximum of 1 joint injection at the time of enrollment) and 10 patients to receive only medical standard of care (also having had a maximum of 1 joint injection prior to enrollment). The goal of this pilot study is to obtain preliminary estimates of safety and efficacy of embolotherapy to provide sustained symptom control and modify disease progression in patients with mild to moderate knee OA.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 40 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Unilaterally dominant symptomatic osteoarthritis (bilateral radiographic OA will not exclude) - Patients who are symptomatically refractory of at least 3 months of medical and/or rehabilitation measures (anti-inflammatory drugs, and/or physical therapy, and/or strength conditioning, and/or 0-1 intra-articular injections of the affected knee) - Kellgren-Lawrence grade 1, 2, or 3 on radiograph of the knee.
  • - Patients who are willing to comply with the protocol requirements and willing to undergo non-contrast MRI 1-30 days prior to procedure and at 12 months following procedure.
  • - Patients who are willing to comply with regular follow up during the 12 month follow-up period.
  • - Patients who have been evaluated by an orthopaedic surgeon or sports medicine provider and deemed to not be a current candidate for partial or total knee arthroplasty.
These patients do, however, need to be considered a potential candidate for partial or total knee as an end point following the natural history of osteoarthritis.
  • - Patients with WOMAC Score >=6 in at least 2 categories.

Exclusion Criteria:

  • - Patients with a weight >250 pounds.
  • - Patients with advanced peripheral arterial disease (resting ABI <= 0.9) - Patients with known significant peripheral arterial disease precluding common femoral catheterization.
  • - Patients who do smoke or have smoked tobacco regularly (smoking 1 or more tobacco product(s) per week) within the last year.
  • - Patients with diabetes who have a hemoglobin A1C of >9% - Patients who have undergone previous lower extremity embolization.
  • - Patients with uncontrolled emotional disorders per patient medical history.
  • - Patients with chronic pain syndrome or currently under a pain contract.
  • - Patients with anatomic variants involving the lower extremities which would increase the risk of non-target embolization.
  • - Patients with renal insufficiency based on an estimated GFR<45 ml/min who are not already on hemodialysis.
  • - Patients with an abnormal INR (>1.5).
  • - Patients with a platelet count <50x109/L.
  • - Patients who are currently receiving medications for anticoagulation which cannot safely be held for the procedure and for 7 days post-procedure.
  • - Patients with a known severe allergy to iodine which cannot be adequately pre-medicated.
  • - Patients who are pregnant or intend to become pregnant within 6 months of the procedure.
  • - Patients with a contraindication to drugs used for moderate sedation during interventional procedures, including Midazolam and Fentanyl.
  • - Patients with a life expectancy <60 months.
  • - Patients who are currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial.
  • - Patients with contraindications to medical and physical rehabilitative treatments of OA.
  • - Patients with known advanced atherosclerosis.
  • - Patients with known current or previous lower extremity fistula.
  • - Patients with rheumatoid arthritis or seronegative arthropathies.
  • - Patients with prior ipsilateral knee surgery.
  • - Patients with WOMAC Pain Scale < 6.
- Patients having received more than one steroid injection in the affected joint or an injection in the affected joint within 3 months of screening

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04456569
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Minnesota
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Reza Talaie, MD
Principal Investigator Affiliation University of Minnesota
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Osteo Arthritis Knee, Arthritis, Osteoarthritis, Osteoarthritis, Knee
Additional Details

This is a single center, two-arm, open label, pilot study to assess feasibility and safety and obtain a preliminary estimate of efficacy of geniculate artery embolization in reducing pain compared to a control group undergoing conservative presurgical management. The 20 patients will be randomly divided into two groups of 10 in 1:1 allocation. One group will have embolization of the geniculate artery branches and standard of care while the other will have only the standard care. Following the completion of the 10 participants in each arm, a safety and data review will be undertaken (Visit 4 in the GAE group and Visit 2 of the SOC). The data will be assessed regarding the trends between the groups as they relate to KOOS/WOMAC pain scale, MRI / Xray evaluation of OA, and presence of inflammatory biomarkers.

Arms & Interventions

Arms

Experimental: GAE + Standard of Care

Participants in this arm will receive geniculate artery embolization and standard of care.

No Intervention: Standard of Care

Participants in this arm will receive standard of care only.

Interventions

Device: - Geniculate Artery Embolization

All patients within the embolization group will undergo unilateral angiography and embolization of the appropriate treatment limb geniculate arteries. For patients with bilateral disease the more clinically symptomatic side will be chosen as the treatment/control knee.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Minnesota, Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota

Minneapolis, Minnesota, 55455

Site Contact

Reza Talaie, MD

[email protected]

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