TY - JOUR
T1 - Active monitoring versus an abduction device for treatment of infants with centered dysplastic hips
T2 - study protocol for a randomized controlled trial (TReatment with Active Monitoring (TRAM)-Trial)
AU - Mulder, Frederike E. C. M.
AU - Witlox, M. Adhiambo
AU - Dirksen, Carmen D.
AU - de Witte, Pieter Bas
AU - de Vos-Jakobs, Suzanne
AU - Ham, Arno M. Ten
AU - Witbreuk, Melinda M. E. H.
AU - Sakkers, Ralph
AU - Drongelen, Magritha Margret M. H. P. Foreman-van
AU - Robben, Simon G. F.
AU - TRAM-Trial Consortium
AU - Mathijssen, Nina M. C.
N1 - Funding Information: The TRAM-Trial is supported by a grant from ZonMw (Grant No. 852002129). The funder had no role in the design of the study, the collection, analysis, and interpretation of the data, the writing of the manuscript, or the decision to submit the manuscript for publication. The authors received no sponsored funding. Publisher Copyright: © 2023, The Author(s).
PY - 2023/12
Y1 - 2023/12
N2 - 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.
AB - 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.
KW - Abduction treatment
KW - Active monitoring
KW - DDH
KW - Developmental dysplasia of the hip
UR - http://www.scopus.com/inward/record.url?scp=85156124209&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s12887-023-04012-2
DO - https://doi.org/10.1186/s12887-023-04012-2
M3 - Article
C2 - 37120559
SN - 1471-2431
VL - 23
SP - 203
JO - BMC Pediatrics
JF - BMC Pediatrics
IS - 1
M1 - 203
ER -