METHODS: In all, 34 patients (34 hips) with unilateral PD had gadolinium-enhanced MRI as part of a prospectively randomized study. Nine patients had three MRIs, 15 had two and ten had a single MRI. Measurement of perfusion of the femoral head (MRI perfusion index) was obtained using digital image analysis on all the MRIs, including both before and after subtraction. A paired sample t-test was performed to compare the measurements.
RESULTS: The mean age of the patients was 8.9 years (sd 1.6). At the time of diagnosis, the subtraction MRI did not elicit a statistically significant difference in MRI perfusion index measurements when compared with the contrast MRI (p = 0.19). The same findings were found when including all patients at various stages of the disease (p = 0.30). Qualitatively, although some subtraction MRI images showed superior delineation of epiphysis, there are no significant differences throughout the whole series.
CONCLUSION: Although the current literature supports the increasing role of the subtraction MRI for PD management, our study proposed that the contrast MRI without subtraction technique appears adequate in assessing femoral head perfusion.
LEVEL OF EVIDENCE: Level I - Diagnostic study.
Methods and analysis: An open-label randomised control trial recruiting 100 children (50 each treatment arm) 5 to 16 years old with unilateral PD. Subjects are randomly assigned to either (a) ZA and standard care or (b) Standard care. The primary outcome measure is deformity index (DI), a radiographic parameter of femoral head roundness assessed at 24 months, following 12 months of ZA treatment (3-monthly doses of ZA 0.025 mg/kg at baseline, 3, 6, 9 and 12 months) plus 12 months observation (group A) or 24 months of observation (group B). Secondary outcome measures are femoral head subluxation, Faces Pain scale, Harris hip score and quality of life. Assessments are made at baseline, 3 monthly during the first year of follow-up and then 6 monthly, until the 24th month.
Ethics and dissemination: The study commenced following the written approval from the Human Research Ethics Committee. Safety considerations regarding the effects of ZA are monitored which include the subject's symptomatology, mineral status, bone mass and turnover activity, and metaphyseal modelling. Data handling plan requires that all documents, clinical information, biological samples and investigation results will be held in strict confidence by study investigators to preserve its safety and confidentiality.
Trial registration number: Australian and New Zealand Clinical Trials ACTRN12610000407099, pre-results.