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

Area of Science:

• Orthopedic surgery
• Biomaterials science
• Medical device engineering

Background:

• A stainless-steel intramedullary lengthening nail (ILN) was recalled in 2021 due to adverse tissue reactions.
• Titanium ILNs from the same manufacturer were developed as an alternative.
• Evaluating the safety and efficacy of titanium ILNs is crucial for patient care.

Purpose of the Study:

• To compare the incidence of periosteal reaction and osteolysis between titanium and recalled stainless-steel ILNs.
• To assess adverse tissue reaction-related device failures in titanium ILNs.
• To determine if titanium ILNs exhibit similar adverse tissue reactions as the recalled stainless-steel version.

Main Methods:

• Radiographic review of patients who received titanium or stainless-steel ILNs.
• Analysis included consecutive cases with at least one year of clinical follow-up.
• Data collected from a single tertiary-care center between February 2012 and July 2021.

Main Results:

• Titanium ILNs (n=226) showed a 0.9% osteolysis rate, compared to 26% in stainless-steel ILNs (n=57).
• Periosteal reaction occurred in 70.8% of titanium ILN cases versus 39% in stainless-steel ILN cases.
• No adverse tissue reaction-related device failures were reported for titanium ILNs; however, other complications like contractures and nerve decompression were noted.

Conclusions:

• The incidence of osteolysis was substantially lower with titanium ILNs, suggesting the issue was specific to the stainless-steel construct.
• Periosteal reactions appeared radiographically later in patients with titanium ILNs compared to stainless-steel.
• Further research is recommended to validate these findings regarding periosteal reaction timing.