Pain,osteolysis, and periosteal reaction are associated with the STRYDE limb lengthening nail: a nationwide cross-sectional study

Background and purpose — Observing serious adverse events during treatment with the Precice Stryde bone lengthening nail (NuVasive, San Diego, CA, USA), we conducted a nationwide cross-sectional study to report the prevalence of adverse events from all 30 bone segments in 27 patients treated in Denmark.Patients and methods — Radiographs of all bone segments were evaluated regarding radiographic changes in February 2021. We determined the number of bone segments with late onset of pain and/or radiographically confirmed osteolysis, periosteal reaction, or cortical hypertrophy in the junctional area of the nail.Results — In 30 bone segments of 27 patients we observed radiographic changes in 21/30 segments of 20/27 patients, i.e., 19/30 osteolysis, 12/30 periosteal reaction (most often multi-layered), and 12/30 cortical hypertrophy in the area of the junction between the telescoping nail parts. Late onset of pain was a prominent feature in 8 patients. This is likely to be a prodrome to the bony changes. Discoloration (potential corrosion) at the nail interface was observed in multiple removed nails. 15/30 nails were still at risk of developing complications, i.e., were not yet removed.Interpretation — All Stryde nails should be monitored at regular intervals until removal. Onset of pain at late stages of limb lengthening, i.e., consolidation of the regenerate, should warrant immediate radiographic examination regarding osteolysis, periosteal reaction, and cortical hypertrophy, which may be associated with discoloration (potential corrosion) of the nail. We recommend removal of Stryde implants as early as possible after consolidation of the regenerate.

Bone reconstruction and lengthening surgery entails many risks and unplanned surgeries are common (Frost et al. 2021, Morrison et al. 2020, Sheridan et al. 2020). However, since many adverse events can be managed with or without surgical intervention without affecting the long-term outcome, Paley (1990) redefined complications by subdividing these adverse events into problems, obstacles, and complications. Similarly, other groups suggest grading the severity of adverse events (class I–II–IIIA–IIIB) and dividing these into device and non-device-related complications (Black et al. 2015, Frost et al. 2021). The introduction of an all internal Stryde bone lengthening nail (NuVasive, Specialized Orthopedics, San Diego, CA) in May 2018 was a game changer for bone-lengthening surgery because it enabled the majority of patient to fully weight-bear. Furthermore, the first publications showed promising clinical results with only few device-related complications and good biocompatibility without signs of corrosion (Robbins and Paley 2020, Iliadis et al. 2021).However, on February 4, 2021 the Danish Medicines Agency released an urgent field safety notice from NuVasive regarding Stryde and all PRECICE system devices. This notice came to prominence based on the British Medicines & Healthcare products Regulatory Agency (MHRA) identifying safety concerns. In the MHRA reference 2020/012/009/226/001 issued January 20, 2021 one concern that was raised was the “unknown long-term biological safety profile. This includes reports of pain and bony abnormalities at the interface between the telescoping nail segments.”We evaluated the prevalence of radiographic changes in terms of osteolysis, periosteal reactions, and cortical hypertrophy at the junction of the telescoping nail segments as well as late onset of pain and/or swelling in the area.