Abstract
Introduction
While advances in joint-replacement technology have made total ankle arthroplasty a viable treatment for end-stage arthritis, revision rates for ankle replacements are higher than in hip or knee replacements [1]. The questions asked in this study were (1) what retrieved ankle devices demonstrate about ankle arthroplasty failures, and (2) how do these failures compare to those seen in the hip and the knee?
Materials and Methods
An IRB-approved retrieval laboratory received retrieved polyethylene inserts and surgeon-supplied reason for revision from 70 total-ankles (7 designs, including five currently-marketed designs) from 2002 to the present. All retrievals were rated for clinical damage. Polyethylene inserts received six months or less after retrieval (n=45) were analyzed for oxidation using Fourier Transform Infrared (FTIR) spectroscopy, reported as maximum ketone oxidation index [2]. Insert sterilization method was verified using trans-vinylene index [3]. Oxidation measured in the 45 ankle inserts versus their time in vivo was compared to oxidation rates previously published for gamma-sterilized hip and knee polyethylene retrievals [6]. Statistical analysis was performed using IBM SPSS v.22.
Results
The ankle devices were retrieved most commonly for loosening (n=22) followed by polyethylene fracture (n=9). These failure modes occurred after statistically different in vivo time (loosening: mean=4.4±3.6 years; polyethylene insert fracture: mean=9.5±4.1 years; p=0.002). Presence of clinical fatigue (cracking and/or delamination) was identified in 24 of the 70 retrieved inserts, and its presence correlated with in vivo time (Spearman's rho =0.449, p<0.001). Thirteen of these fatigued inserts were analyzed by FTIR. TVI analysis confirmed the sterilization method of the fatigued inserts: 12 gamma, 1 non-gamma sterilized. All 13 fatigued inserts had maximum ketone oxidation index (KOI) of 1.2 or higher. Presence of fatigue correlated with measured oxidation (Spearman's rho =0.685, p<0.001). Six of the 9 inserts that fractured in vivo were analyzed by FTIR. All were gamma-sterilized, and all had oxidation of 1.2 or higher. Oxidation rate determined for most of the 45 ankle inserts was at or above oxidation rates previously published for gamma-sterilized hip and knee polyethylene retrievals [6].
Discussion
This retrieval study concurs with the ankle arthroplasty literature that loosening is the most common reason for ankle revision [4]. Ankle inserts retrieved as a result of implant loosening had lower oxidation and no fatigue damage resulting from their shorter in vivo time. Fatigued and/or fractured inserts were in vivo for longer times, allowing more oxidation to occur. The effect of oxidation on polyethylene tensile strength and ductility has been reported for tibial inserts [5]. Oxidation above the critical value [5] has a dramatic effect on the ability of the polyethylene to resist fatigue damage and fracture, since the toughness of the polyethylene drops to near zero. All fatigued and fractured ankle inserts had oxidation that exceeded this critical oxidation. Most ankle inserts, whether gamma or non-gamma sterilized, oxidized at or above the oxidation rates previously published for gamma-sterilized hip and knee polyethylene retrievals [6].
