title: Development and first validation of a simplified CT-based classification system of soft tissue changes in large-head metal-on-metal total hip replacement: intra- and interrater reliability and association with revision rates in a uniform cohort of 664 arthroplasties.
abstract: OBJECTIVE
  After implantation of a metal-on-metal total hip arthroplasty (MoM THA), a large incidence of pseudotumor formation has been described recently. Several centers have invited patients for follow-up in order to screen for pseudotumor formation. The spectrum of abnormalities found by CT in MoM THA patients can be unfamiliar to radiologists and orthopedic surgeons. Previously, a CT five-point grading scale has been published. In this paper, a simplification into a three-point classification system gives insight in the morphological distinction of abnormalities of the postoperative hip capsule in MoM implants in relation to the decision for revision. The reliability of this simplified classification regarding intra- and interrater reliability and its association with revision rate is investigated and discussed.
  
  
  METHODS
  All patients who underwent MoM THA in our hospital were invited for screening. Various clinical measures and CT scan were obtained in a cross-sectional fashion. A decision on revision surgery was made shortly after screening. CT scans were read in 582 patients, of which 82 patients were treated bilaterally. CT scans were independently single read by two board-certified radiologists and classified into categories I-V. In a second meeting, consensus was obtained. Categories were subsequently rubricated in class A (categories I and II), B (category III), and C (categories IV and V). Intra- and inter-radiologist agreement on MoM pathology was assessed by means of the weighted Cohen's kappa. Categorical data were presented as n (%), and tested by means of Fisher's exact test. Continuous data were presented as median (min-max) and tested by means of Mann-Whitney U test (two group comparison) or Kruskal-Wallis test (three group comparison). Logistic regression analysis was performed in order to study independence of CT class for association with revision surgery. Univariate statistically significant variables were entered in a multiple model. All statistical analysis was performed two-tailed using alpha 5% as the significance level.
  
  
  RESULTS
  In total, 664 scores from 664 MoM hips obtained by two observers were available for analyses. Interobserver reliability for the non-simplified version (I-V) was κw = 0.71 (95% CI: 0.62-0.79), which indicates good agreement between the two musculoskeletal radiologists. Intra- and interobserver reliability for the simplified version (A-C) were respectively κw 0.78 (95% CI: 0.68-0.87), and κw = 0.71 (95% CI: 0.65-0.76). This indicates good agreement within and between the two observers. The simplified A-C version is significantly associated with revision exclusively due to MoM pathology, in both patients with unilateral MoM THA (p < 0.001) and patients with bilateral MoM THA (p < 0.044). The simplified A-C version is associated with several clinical measures. In patients with unilateral MoM THA, with or without contralateral THA, in situ time (p < 0.008), cobalt and chromium (p < 0.001) were statistically significant. In patients with bilateral MoM, cobalt (p < 0.001) and chromium (p < 0.027) were statistically significant. Revision is significantly associated with cup size (p < 0.001), anteversion of the cup (p < 0.004), serum ion levels of cobalt and chromium (p < 0.001) and the adapted classification system (p < 0.001). In univariate logistic regression analysis on revision, cup, anteversion of the cup, cobalt-chromium ion serum levels, and the simplified (A-C) CT category system were statistically significant. The simplified (A-C) CT category system was an independent associate of revision, in several multiple logistic regression models.
  
  
  CONCLUSIONS
  The presented simplified CT grading system (A-C) in its first clinical validation on 48- and 64-multislice systems is reliable, showing good intra- and interrater reliability and is independently associated with revision surgery.
authors.affiliation: Department of Radiology, Isala Hospital, Zwolle, The Netherlands, m.f.boomsma@isala.nl.
authors.forename: Martijn F
authors.initials: MF
authors.lastname: Boomsma
authors.forename: Mireille A
authors.initials: MA
authors.lastname: Edens
authors.forename: Christiaan P
authors.initials: CP
authors.lastname: Van Lingen
authors.forename: Niek
authors.initials: N
authors.lastname: Warringa
authors.forename: Harmen B
authors.initials: HB
authors.lastname: Ettema
authors.forename: Cees C P M
authors.initials: CC
authors.lastname: Verheyen
authors.forename: Mario
authors.initials: M
authors.lastname: Maas
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019644:Arthroplasty, Replacement, Hip / Q000295:instrumentation / Q000706:statistics & numerical data; D015331:Cohort Studies; D005260:Female; D006104:Granuloma, Plasma Cell / Q000000981:diagnostic imaging* / Q000453:epidemiology*; D006622:Hip Prosthesis / Q000706:statistics & numerical data*; D006801:Humans; D015994:Incidence; D008297:Male; D061825:Metal-on-Metal Joint Prostheses / Q000706:statistics & numerical data*; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D012086:Reoperation / Q000706:statistics & numerical data; D015203:Reproducibility of Results; D018570:Risk Assessment / Q000379:methods; D012680:Sensitivity and Specificity; D018461:Soft Tissue Infections / Q000000981:diagnostic imaging / Q000453:epidemiology; D014057:Tomography, X-Ray Computed / Q000379:methods* / Q000706:statistics & numerical data*; D016896:Treatment Outcome; D055815:Young Adult