Active monitoring versus an abduction device for treatment of infants with centered dysplastic hips: study protocol for a randomized controlled trial (TReatment with Active Monitoring (TRAM)-Trial).

BACKGROUND: Developmental Dysplasia of the Hip (DDH) is one of the most common pediatric orthopedic disorders, affecting 1-3% of all newborns. The optimal treatment of centered DDH is currently under debate. This randomized controlled trial aims to study the (cost-)effectiveness of active monitoring versus abduction treatment for infants with centered DDH. METHODS: This is a multicenter, parallel-group, open-label, non-inferiority randomized controlled trial studying the (cost-)effectiveness of active monitoring versus abduction treatment for infants with centered DDH in fourteen hospitals in the Netherlands. In total, 800 infants with centered DDH (Graf IIa-/IIb/IIc), aged 10-16 weeks, will be randomly allocated to the active monitoring or abduction treatment group. Infants will be followed up until the age of 24 months. The primary outcome is the rate of normal hips, defined as an acetabular index lower than 25 degrees on an antero-posterior radiograph, at the age of 12 months. Secondary outcomes are the rate of normal hips at the age of 24 months, complications, time to hip normalization, the relation between baseline patient characteristics and the rate of normal hips, compliance, costs, cost-effectiveness, budget impact, health-related quality of life (HRQoL) of the infant, HRQoL of the parents/caregivers, and parent/caregiver satisfaction with the treatment protocol. DISCUSSION: The outcomes of this randomized controlled trial will contribute to improving current care-as-usual for infants with centered DDH. TRIAL REGISTRATION: Dutch Trial Register, NL9714, registered September 6, 2021. https://clinicaltrialregister.nl/en/trial/29596.

Active monitoring versus immediate abduction as treatment of stable developmental dysplasia of the hip: a systematic review of the literature.

OBJECTIVES: This systematic review aims to compare the effects of active monitoring and abduction treatment on the Graf alpha angle, Acetabular Index (AI) and femoral head coverage in infants with stable developmental dysplasia of the hip (DDH). DESIGN: Systematic review reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. DATA SOURCES: A search of the PubMed, Embase, Cochrane and Web of Science databases was performed in January 2020 and updated in January 2021. ELIGIBILITY CRITERIA: (Non-)randomised studies comparing active monitoring with abduction treatment in infants younger than 4 months with stable DDH were included. DATA EXTRACTION AND SYNTHESIS: All eligible articles were methodologically assessed using the Cochrane risk of bias tools. Data were extracted by summarising the study characteristics and results. RESULTS: Of the six included studies, two randomised studies were of low risk and two of some concerns. Two non-randomised studies were of serious risk. In total, 544 dysplastic hips (439 infants) were investigated, of which 307 were observed and 237 were treated. Two studies reported a faster improvement of the alpha angle and average acetabular coverage in treated hips at 3 months. No differences in AI between the treatment and observation group after 3 months were reported. In total, 38 infants (12%) in the observation group switched to the treatment group. At the final radiograph, 21 observed hips and 32 treated hips were dysplastic. CONCLUSIONS: There were no differences in AI between the treatment and observation group after 3 months in infants up to 4 months of age with stable DDH hips. The switch of 38 infants (12%) from the observation to the treatment group corroborates that not all infantile DDH hips will spontaneously progress into normal hips. The small study population sizes and methodological heterogeneity warrant a large randomised controlled trial to study this research question. PROSPERO REGISTRATION NUMBER: CRD4202123300.

The burden of colorectal cancer survivors in the Netherlands: costs, utilities, and associated patient characteristics.

PURPOSE: The aim of this study is to assess the societal burden of colorectal cancer (CRC) survivorship 2-10 years post-diagnosis in terms of (1) societal costs, and (2) quality of life/utilities, and to analyze associated patient characteristics. METHODS: This is a cross-sectional, bottom-up prevalence-based burden of disease study, conducted from a societal perspective in the Netherlands. In total, 155 CRC survivors were included. Utilities were measured by the EQ-5D-5L, using the Dutch tariffs. A cost questionnaire was developed to obtain cost information. Subgroup analyses were performed, based on patient characteristics and sensitivity analyses. RESULTS: Of all CRC survivors, 81(54%) reported no problems for mobility, 133(88%) for self-care, 98(65%) for daily activities, 59(39%) for pain/discomfort, and 112(74%) for anxiety/depression on the EQ-5D-5L. The average EQ-5D-5L utility score was 0.82 (SD = 0.2) on a scale from 0 (death) to 1 (perfect health). Significant differences in utility score were found for gender, tumor stage, number of comorbidities, and lifestyle score. The average societal costs per CRC survivor per 6 months were estimated at €971 (min = €0, max = €32,425). Significant differences in costs were found for the number of comorbidities. CONCLUSIONS: This study shows a considerable burden of CRC survivors 2-10 years after diagnosis, in comparison with survivors sooner after diagnosis and with healthy individuals in the Netherlands. IMPLICATIONS FOR CANCER SURVIVORS: Long-term care of CRC survivors should focus on improving the societal burden by identifying modifiable factors, as summarized in the WCRF/AICR lifestyle score, including body composition, physical activity, and diet.

Effect of the Sharrard procedure on hip instability in children with Down syndrome: a retrospective study.

PURPOSE: The aim of this study was to retrospectively analyze the effect of the Sharrard procedure on hip instability in children with Down syndrome (DS), as measured by the migration index. METHODS: In total, 17 children (21 hips) were included from six hospitals in the Netherlands between 2003 and 2019. The primary outcome, hip instability, was assessed with the Reimers' migration index on preoperative and postoperative plain anteroposterior pelvic radiographs. The mean age at surgery was 8.1 years, the majority of children were male (64.7%) and the mean follow-up time was 7.3 years. RESULTS: The mean preoperative migration index was 46% (sd 23.5) and the mean postoperative migration index was 37% (sd 28.4). The mean Delta migration index (the difference in pre-operative migration index and most recent post-operative migration index) showed an improvement of 9.3% (sd 22.7). An improvement in migration index was observed in 52%, no change in 29% and deterioration in 19% of hips. No (re)dislocations occurred in 91% of the hips. No major complications were observed during the follow-up period. CONCLUSION: Early intervention is warranted in children with DS showing hip instability or hip migration, in order to succeed with less complex procedures. The Sharrard procedure should be considered in children with DS showing hip instability or hip migration, since it aims to rebalance the muscles of the hip joint, is less complex than bony procedures of the femur and acetabulum, surgery time is often shorter, there are fewer major complications and the rehabilitation period is shorter. LEVEL OF EVIDENCE: IV - retrospective case series.