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

Abstract

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 Lengthening with a Motorized Intramedullary Nail in 34 Patients with Posttraumatic Limb Length Discrepancies

“…Some of these reoperations were due to device-related complications. However, besides the recently reported adverse events of the latest generation of magnetically controlled limb lengthening nails, i.e., STRYDE, both FITBONE ® and titanium PRECICE ® have proven their clinical reliability and safety for many years [24][25][26][27][28][29]. Thaller et al performed 241 FITBONE ® surgeries from 1999 until 2009 and imply that corrosion and osteolysis may also apply to a "number of FITBONE" [30].…”

The STRYDE limb lengthening nail is susceptible to mechanically assisted crevice corrosion: an analysis of 23 retrieved implants

“…We performed an analysis of all STRYDE nails, removed either routinely, due to complications, or preemptively due to our recent discovery of adverse events with this implant (Rölfing et al 2021a). STRYDE nails from the 4 centers-Aarhus University Hospital, Aalborg University Hospital, Odense University Hospital, and Rigshospitalet, Copenhagen, Denmark-were visually inspected and photo documented (Figure 1, see Supplementary data).…”

“…Moreover, 4 of the 27 retrieved STRYDE nails fractured, 3 before and 1 during hardware removal. All 4 patients were within the weight limit of the applied nail (Robbins and Paley 2020, Rölfing et al 2021a. Notably, the bone regenerate was deemed to be sufficiently healed in 1 patient, while 3 regenerates were insufficient.…”

“…The study was conducted with consent of the patients according to the Declaration of Helsinki and was approved by the local institutional review boards. Rölfing et al (2021a).…”

“…Observing several adverse events, we recently published a nationwide cross-sectional analysis of all 30 STRYDE limblengthening nails (NuVasive, Specialized Orthopedics, San Diego, CA) that were implanted in Denmark (Rölfing et al 2021a). 27/30 STRYDE nails have now been removed and we present data from metallurgical analysis of 23 of the retrieved implants.…”