Characterization of ion release from a novel biomaterial, Molybdenum-47.5Rhenium, in physiologic environments

Abstract

Background context: Metals from spinal implants are released into surrounding tissues by various mechanisms. Metal ion release has been associated with clinical implant failure, osteolysis, and remote site accumulation with adverse events. Significant corrosion and associated metal ion release has been described with currently used spinal implant alloys. A novel metal alloy, Molybdenum-47.5Rhenium alloy (MoRe®), was approved for use in medical implants in 2019 by the FDA.

Purpose: To evaluate the metal ion release profile of MoRe alloy after immersion in both a stable physiologic, as well as in an inflammatory environment.

Study design: In vitro study.

Methods: The ion release profile of the MoRe alloy was comprehensively evaluated in-vitro after prolonged immersion in physiologic and inflammatory environments. Ion concentration analyses were then conducted using inductively coupled plasma-mass spectrometry (ICP-MS) methods. Comparative testing of titanium (Ti-6Al-4V) and cobalt chromium (Co-28Cr-6Mo) was also performed.

Results: Under baseline physiologic conditions, the MoRe alloy demonstrates very low molybdenum and rhenium ion release rates throughout the 30-day test period. During the first time interval (day 0-1), low levels of molybdenum and rhenium ions are detected (<0.3 μg/cm² day) followed by a rapid reduction in the ion release rates to <0.05 μg/cm² day during the second time interval (days 1-3) followed by a further reduction to very low steady-state rates <0.01 μg/cm² day during the third time interval (days 3-7), which were maintained through 30 days. In the inflammatory condition (H₂O₂ solution), there was a transient increase in the release of molybdenum and rhenium ions, followed by a return to baseline ion release rates (days 2-4), with a further reduction to low steady-state rates of ∼0.01 μg/cm² day (days 4-8). The measured molybdenum and rhenium ion release rates in both steady state (<0.01 μg/cm² day), and inflammatory environments (0.01 μg/cm² day) were far below the established FDA-permitted daily exposure (PDE) of 1,900 μg/cm² day for molybdenum and 4,400 μg/cm² day for rhenium. In contrast, titanium and cobalt chromium approached or exceeded their established PDE values in an inflammatory environment.

Conclusions: The novel biomaterial MoRe demonstrated a lower metal ion release profile in both a physiologic and inflammatory environment and was well below the established PDE. Comparative testing of the cobalt-chromium and titanium alloys found higher levels of ion release in the inflammatory environment that exceeded the PDE for cobalt and vanadium.

Keywords: Biomaterial; Cobalt Chromium; Corrosion; Instrumented spinal fusion; Metal ion release; Metal toxicity; Metallosis; MoRe; Molybdenum; Molybdenum-47.5Rhenium; Rhenium; Spinal fusion implants; Spinal instrumentation; Titanium; Wear debris.