Incidence of Focal Osteolysis in a Titanium Limb-Lengthening Device: A Comparison to a Stainless-Steel Model

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Abstract
Objectives: To evaluate 1 manufacturer's titanium intramedullary lengthening nail (ILN) for radiographic evidence of adverse tissue reactions similar to those in their stainless-steel ILN that was recalled in 2021, with specific outcomes of (1) incidence of periosteal reaction and osteolysis and (2) adverse tissue reaction-related device failures. Design: Radiographic review of consecutive patients with ≥1-year clinical follow-up who received 1 manufacturer's ILNs implanted in the femur and/or tibia from February 2012 to July 2021. Setting: Single tertiary-care center. Patients/Participants: Two hundred twenty-six limbs with titanium ILNs and 57 limbs with stainless-steel ILNs. Intervention: Precice titanium ILN (NuVasive Specialized Orthopedics, San Diego, CA) and Stryde stainless-steel ILN (NuVasive Specialized Orthopedics). Main Outcome Measurements: Radiographic outcome data and complications. Results: Of 226 limbs with titanium ILNs, 160 (70.8%) had periosteal reaction, and 2 (0.9%) had osteolysis. Periosteal reaction and osteolysis rates in stainless-steel ILNs (57 limbs) were 39% and 26%, respectively. No adverse tissue reaction-related device failures were noted with titanium. Several other complications presented, notably hip and/or knee tissue contracture (141), consolidation problems (8), and needing peroneal nerve decompression (14). Conclusions: Osteolysis incidence was substantially less among the titanium population, supporting the claim that observed osteolysis in the stainless-steel cohort was attributed to its construct. On average, periosteal reaction was radiographically appreciated later in patients with titanium than stainless steel. Further study is needed to confirm this finding. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

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