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J Knee Surg. 2014 Apr;27(2):99-104. doi: 10.1055/s-0033-1348407. Epub 2013 Jul 19.

No conclusive evidence that histologically found granulomas and acute local reactions following hylan G-F 20 injections are related or have clinical significance.

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  • 1Department of Orthopedics, Orthopedic Specialists of Louisiana, Shreveport, Louisiana.
  • 2Department of Orthopedics, Newport Orthopedic Institute, Newport Beach, California.
  • 3Department of Orthopedics, Howard University Hospital, Washington, District of Columbia.
  • 4Department of Clinical Research, Genzyme Biosurgery, Cambridge, Massachusetts.
  • 5Department of Biostatistics, Genzyme Biosurgery, Cambridge, Massachusetts.
  • 6Department of Anatomic Pathology, University of Miami Hospital, Miami, Florida.
  • 7Department of Orthopedics, Cedars-Sinai Orthopedics, San Francisco, California.


Osteoarthritic (OA) knee pain can be successfully treated with hylan G-F 20 (Synvisc, Sanofi Biosurgery, Cambridge, MA) with few local adverse events. However, a few studies have identified hyaluronate positive (HA+) granulomas in the synovial tissue of patients treated with hylan G-F 20 raising the question of their relationship and clinical significance. To understand the potential relationship of HA+ granulomas with the occurrence of acute local reactions (ALRs), we evaluated the synovial tissue of OA patients undergoing total knee replacement that had previously been treated with hylan G-F 20 (nā€‰=ā€‰101) or had not been treated (nā€‰=ā€‰20). Granulomas were observed in nine patients, of which eight were in the hylan G-F 20 group (7.9%); HA+ granulomas were identified in six of these eight patients (5.9%). Three of the six patients with HA+ granulomas experienced an ALR within 30 days of administering an injection. Overall, we found no consistent relationship between histologically found HA+ granulomas and the occurrence of an ALR following hylan G-F 20 treatment. These microscopic granulomas were not associated with any symptoms and likely have little clinical significance. The low occurrence of granulomas and/or ALRs should not preclude use of hylan G-F 20 for the treatment of knee pain associated with OA.

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