What Is the Impact of Center Variability in a Multicenter International Prospective Observational Study on Developmental Dysplasia of the Hip?

BACKGROUND: Little information exists concerning the variability of presentation and differences in treatment methods for developmental dysplasia of the hip (DDH) in children < 18 months. The inherent advantages of prospective multicenter studies are well documented, but data from different centers may differ in terms of important variables such as patient demographics, diagnoses, and treatment or management decisions. The purpose of this study was to determine whether there is a difference in baseline data among the nine centers in five countries affiliated with the International Hip Dysplasia Institute to establish the need to consider the center as a key variable in multicenter studies. QUESTIONS/PURPOSES: (1) How do patient demographics differ across participating centers at presentation? (2) How do patient diagnoses (severity and laterality) differ across centers? (3) How do initial treatment approaches differ across participating centers?
METHODS: A multicenter prospective hip dysplasia study database was analyzed from 2010 to April 2015. Patients younger than 6 months of age at diagnosis were included if at least one hip was completely dislocated, whereas patients between 6 and 18 months of age at diagnosis were included with any form of DDH. Participating centers (academic, urban, tertiary care hospitals) span five countries across three continents. Baseline data (patient demographics, diagnosis, swaddling history, baseline International Hip Dysplasia Institute classification, and initial treatment) were compared among all nine centers. A total of 496 patients were enrolled with site enrolment ranging from 10 to 117. The proportion of eligible patients who were enrolled and followed at the nine participating centers was 98%. Patient enrollment rates were similar across all sites, and data collection/completeness for relevant variables at initial presentation was comparable.
RESULTS: In total, 83% of all patients were female (410 of 496), and the median age at presentation was 2.2 months (range, 0-18 months). Breech presentation occurred more often in younger (< 6 months) than in older (6-18 months at diagnosis) patients (30% [96 of 318] versus 9% [15 of 161]; odds ratio [OR], 4.2; 95% confidence interval [CI], 2.3-7.5; p < 0.001). The Australia site was underrepresented in breech presentation in comparison to the other centers (8% [five of 66] versus 23% [111 of 479]; OR, 0.3, 95% CI, 0.1-0.7; p = 0.034). The largest diagnostic category was < 6 months, dislocated reducible (51% [253 of 496 patients]); however, the Australia and Boston sites had more irreducible dislocations compared with the other sites (ORs, 2.1 and 1.9; 95% CIs, 1.2-3.6 and 1.1-3.4; p = 0.02 and 0.015, respectively). Bilaterality was seen less often in older compared with younger patients (8% [seven of 93] versus 26% [85 of 328]; p < 0.001). The most common diagnostic group was Grade 3 (by International Hip Dysplasia Institute classification), which included 58% (51 of 88) of all classified dislocated hips. Splintage was the primary initial treatment of choice at 80% (395 of 496), but was far more likely in younger compared with older patients (94% [309 of 328] versus 18% [17 of 93]; p < 0.001).
CONCLUSIONS: With the lack of strong prognostic indicators for DDH identified to date, the center is an important variable to include as a potential predictor of treatment success or failure.