Elbow Artery Embolization for Tennis Elbow

This is a single-center, prospective, single arm investigational study to evaluate the safety of elbow artery embolization (EAE) for treatment of symptomatic lateral epicondylitis. In addition, the improvement as part of efficacy will be reported. All patients will have either failed or be intolerant to conservative management. Patients will be considered enrolled in the study once they have provided informed consent and have been determined to meet all eligibility criteria. A total of 25 patients will be enrolled in the single treatment arm of the study and will be followed for 24 months.

The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, subjects will undergo EAE with Embozene microspheres (75 micron). Following treatment, subjects will return for follow-up visits at 1 week, 1 month (± 2 weeks), 3 months (± 2 weeks), 6 months (± 4 weeks), 12 months (± 4 weeks), and 24 months (± 4 weeks) post-procedure. At these visits, subjects will undergo a directed physical examination, report any new adverse events (AEs), and complete questionnaires. At 12 months of follow-up, subjects will also undergo elbow MRI and x-ray.

Inclusion criteria

• Age ≥ 18 years
• Diagnosis of lateral epicondylitis based on history and physical exam
• Ability to provide informed consent
• Life expectancy greater than 12 months
• Moderate-severe lateral elbow pain as determined by visual analog scale > 4 (based on average severity during physical activity)
• Resistant/failed conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection) for at least 6 months.

Exclusion criteria

• Mild elbow pain as determined by visual analog scale < 4
• Chronic renal insufficiency (serum creatinine >2 mg/dL)
• Allergy to iodinated contrast agents that is not responsive to steroid management
• Active Infection or malignancy
• Prior elbow surgery in the subject elbow
• Uncorrectable bleeding diathesis