Abstract
The CCI mobile bearing ankle implant used at our orthopedic department 2010–2013, was abandoned due to failures and findings of bone loss at revision. The aim of this study was to a) Determine our true revision rate, b) Investigate accuracy of measuring prevalence, size and location of periprosthetic bone cysts through X-ray and CT and c) Relate these findings to implant alignment and patient reported outcome measurements (PROMs).
51 primary surgeries were performed, prior to this study 8 had been revised. Out of 43 un-revised patients, 36 were enrolled and underwent evaluation with metal artefact reduction CT-scans and conventional X-ray. They filled out 3 PROMs; SEFAS, SF-12, EQ-5D. Cyst volume larger than 0.1 ml was measured using VITREA volume tools for CT-scans and calculation of spherical volume for X-rays; using AP- and lateral projections. Location of lesions was recorded, according to their position relative to the implant. Medial-/lateral- and anterior-/posterior tilt of the implant parts was measured using IMPAX built in measuring tools, applied to AP- and lateral X-ray projection. The relation between lesions location and alignment of components was analyzed by logistic regression. Bias and ICC estimation between CT and X-ray was analyzed by mixed effect model. Log transformation was used to fit the normal distribution assumption. PROMs association to osteolytic volume was analyzed by linear- and logistic regression. P-values of 0.05 were considered statistically significant.
Finding large osteolytic lesions caused 4 additional patients to undergo revision and 7 are being monitored due to high risk of failure. Of the original 51 implants 14 have been revised. 8 cases because of osteolytic lesions and aseptic loosening (true revisions w. exchange of components or bone transplants), 3 periprosthetic fractures (2 non-traumatic fractures) and 3 cases of exostosis. The 3- and 5 year revision rate was 14% and 16% for true revisions and 17% and 27% overall. Cystic lesions were found in 81% of participants. Total cyst-volume was on average 13% larger on X-ray, however this difference was not significant (p = 0.55), with intraclass correlation being 0.66. Total cystic volume was not significantly related to PROM-scores (P 0.16–0.5). Location of cysts showed association with alignment of components (P 0.02–0.08). Mean tibia component anterior tilt was 89 degrees (SD 4). Mean medial tilt was 91 degrees (SD 3) for the tibial and 90 degrees (SD 4) for the talar component.
The implant investigated performs below standard, compared to public registries1, 2that report overall 5 year revision rates at 5 – 6.5%. We obtained larger measurements from X-rays than CT, unlike previous studies comparing these modalities. Cysts were common and large. Correlation between lesion location and alignment of implant, with valgus and anterior tilt of components causing more lesions in adjacent zones, may suggest a link between implant failure and alignment of components.
