Abstract
Introduction
Failure rates of Metal-on-Metal (MoM) ASR XL hip implants have been unacceptably high compared with other bearing surfaces, so patients must be monitored over the time checking for disorders in clinical condition, blood tests or in diagnostic imaging.
Objectives
We have carried out a continuing prospective investigation to evaluate the relationship between blood metal ions measurements and ultrasound levels and to evaluate if ultrasound score can predict a future indication to revision.
Materials and methods
From DePuy Recall of 2010 we have monitored 106 patients (51 males, 55 females, mean age 63.6) with ASRXL implants. The controls were performed annually. The following scales were used for patients evaluation:
Ultrasound score: 0 none; 1 fluid collection <20 mm, 2 fluid collection <20 mm, 3 solid mass: metallosis. Blood metal levels of Chromium-Cobalt (Cr-Co) (μg/l = ppb): normal <3 ppb, alert between 3 and 7 ppb, pathologic <7 ppb. Clinical Score: Harris Hip Score. Rx score, evaluating the prosthetic-bone integration and the inclination of acetabular component.
Patients who presented positive clinical-instrumental conditions and values of Cr and Co > 3 mg/l were checked every 6 months.
Statistical analysis was carried out with Non-parametric Kruskal-Wallis test and two factors Analysis of Variance using SAS System vers. 9.4
Results
The follow-up included 110 implants (4 are bilateral case). 43 patients (39,1 %) underwent revision surgery for failed MoM utilizing ceramic-on-polyethylene devices. At a mean time of 65,7 +/− 15,9 months, 47 patients had a ultrasound score of 0 (13 revised), 32 patients had a ultrasound score of 1 (9 revised), 20 patients had a ultrasound score of 2 (15 revised), 7 patients had a ultrasound score of 3 (6 revised); 44 patients had Cr value < 3 ppb (5 revised), 28 patients had Cr value <3 ppb<7 (6 revised), 34 patients had Cr value <7 ppb (32 revised), 25 patients had Co value < 3 ppb (5 revised), 20 patients had Co value <3 ppb<7 (1 revised), 61 patients had Co value > 3 ppb (37 revised). A positive correlation between blood metal ions values and ultrasound levels (p<0,001) and a statistically significant interaction between ultrasound score and indication to revision (p=0,037) were found.
Discussion and Conclusion
As reported in literature also in our experience the ASR XL implant was afflicted by an excessive revision rate, associated with levels of metal ions significantly higher than other hip bearing surfaces. Our results demonstrate a positive correlation between blood Cr and Co levels and the amount of fluid collection: at higher levels of fluid collection correspond higher levels of blood metal ions. Since statistical analysis confirmed that the level of ultrasound score is correlated with indication to revision it is suggested to use ultrasounds, if the score is 2 or more, as parameter to revise MoM implants even in absence of pathologic blood ions levels.
