ATHN 3 – Radionuclide Synovectomy/Synoviorthesis (RS) in Patients With Bleeding Disorders: A Review of Outcomes and Adverse Events in the ATHNdataset
Radionuclide synvectomy (RS) is a procedure that has been used for many years in the bleeding disorder community. ATHN 3 study analyzes data in the ATHNdataset to better understand the usage, complications and risks associated with the procedure.
Radionuclide synovectomy/synoviorthesis has been used to treat synovitis in persons with hemophilia and other bleeding disorders through the instillation of radio-pharmaceuticals into the affected joint. However, safety concerns have been raised due to exposure to ionizing radiation. Worldwide, 3 cases of malignancy (2 acute leukemia and 1 Ewing sarcoma) and 1 case of severe aplastic anemia have been reported since 2002 in pediatric patients with bleeding disorders who have undergone the procedure. These reports prompted The Medical and Scientific Advisory Council of the National Hemophilia Foundation to issue guidance in 2006 on the use of this procedure as well as a Med Watch warning from the U.S. Food and Drug Administration. Some centers stopped performing the procedure.
Prior to the ATHNdataset, no nationwide dataset existed to track the numbers of procedures performed in the U.S. or the safety of this procedure. A side benefit is learning where these procedures can still be obtained.
Principal Investigator: Amy L. Dunn, MD, Nationwide Children’s Hospital. Study Design: Retrospective Analysis of the ATHNdataset
Study Objectives: The study is designed to test the following hypotheses:
- Hypothesis 1: Patients with severe bleeding disorders are more likely to have had RS (single or multiple injections) than those with mild bleeding disorders.
- Hypothesis 2: Patients with bleeding disorders who have undergone RS may be at increased risk of hematologic/oncologic complications that are not directly related to their bleeding disorder
- Hypothesis 3: Patients with bleeding disorders who have undergone RS are at risk for decreased range-of-motion compared to patients who have not had RS.
- Hypothesis 4: Patients who have has RS are at increased risk for requiring subsequent joint intervention/surgery.
To learn more about the key findings: See the 2015 ATHN Data Summit presentation.