Retrieval Analysis of 2nd Generation HXLPE Used in Total Hip and Knee Arthroplasty

Introduction:

First generation highly crosslinked polyethylenes (HXPLEs) have proven successful in lowering both penetration and osteolysis rates. However, 1^st generation annealing and remelting thermal stabilization have been associated with in vivo oxidation or reduced mechanical properties. Thus, 2^nd generation HXLPEs were developed to improve oxidative stability while still maintaining material properties. Little is known about the in vivo clinical failure modes of these 2^nd generation HLXPEs.

The purpose of this study was to assess the revision reasons, wear, oxidative stability, and mechanical behavior of retrieved sequentially annealed Vitamin E diffused HXLPE in THA and TKA.

Methods:

251 2^nd Generation HXLPE hip and knee components were consecutively retrieved during revision surgeries and continuously analyzed in a prospective, IRB approved, multicenter study. 123 acetabular liners (Implanted 1.2y; Range 0–5.0y) and 117 tibial inserts (Implanted 1.6y; Range 0–5.8y) were highly crosslinked and annealed in 3 sequential steps (X3). Five acetabular liners (Implanted 0.6y; Range 0–2.0y) and six tibial inserts (Implanted 1.3y; Range 0.5–1.8y) were diffused with Vitamin E (E1). Patient information was collected from medical records (Table 1).

Linear penetration of liners was measured using a calibrated digital micrometer (accuracy: 0.001 mm). Surface damage of tibial components was assessed using the Hood method. Thin sections were taken from the acetabular liners (along the superior/inferior axis) and the tibial components (along the medial condyle and central spine) for oxidation analysis and analyzed according to ASTM 2102. Mechanical behavior was assessed via the small punch test (ASTM 2183).

Results:

The liners and tibial components fabricated from both HXLPEs were revised predominantly for loosening, instability, and infection (Figure 1). The average penetration rate for the Sequentially Annealed group was low (PR = 0.045 mm/yr). Pitting, scratching and burnishing were the predominant damage mechanisms of the tibial inserts within both material groups, with no evidence of delamination. Oxidation indices were low (Mean OI≤0.3) and similar between liners and inserts of the Sequentially Annealed components at the bearing and backside surface (Figure 2, p ≥ 0.15). Oxidation was positively correlated with implantation time at the bearing surface of the Sequentially Annealed groups (Rho > 0.29, p < 0.005). The Ultimate Load of the Sequentially Annealed acetabular liners was statistically higher than the tibial components (p < 0.001), however the mean difference was minimal (∼6N).

Discussion:

This study evaluated the properties of 2^nd generation HXLPEs used in THA and TKA. Sequentially Annealed liners had penetration rates comparable with 1^st generation HXLPEs. While oxidation was low for both sequentially annealed and Vitamin E HXLPEs, we were able to detect regional variations in the oxidative in the sequentially annealed cohort. Longer-term retrievals are necessary to fully assess the oxidative stability of Vitamin E diffused HXLPE used in TKA and THA.