Top

Published in:

Open Access 01-12-2023 | Hip Dysplasia | Study protocol

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)

Authors: Frederike E. C. M. Mulder, M. Adhiambo Witlox, Carmen D. Dirksen, Pieter Bas de Witte, Suzanne de Vos-Jakobs, Arno M. ten Ham, Melinda M. E. H. Witbreuk, Ralph Sakkers, Magritha (Margret) M. H. P. Foreman-van Drongelen, Simon G. F. Robben, Nina M. C. Mathijssen, TRAM-Trial Consortium

Published in: BMC Pediatrics | Issue 1/2023

Abstract

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

Schaeffer EK, Study Group I, Mulpuri K. Developmental dysplasia of the hip: addressing evidence gaps with a multicentre prospective international study. Med J Aust. 2018;208(8):359–64.CrossRefPubMed

Pollet V, Percy V, Prior HJ. Relative risk and incidence for developmental dysplasia of the hip. J Pediatr. 2017;181:202–7.CrossRefPubMed

Kilsdonk I, Witbreuk M, Van Der Woude HJ. Ultrasound of the neonatal hip as a screening tool for DDH: how to screen and differences in screening programs between European countries. J Ultrason. 2021;21(85):e147–53.CrossRefPubMedPubMedCentral

Engesæter I, Lehmann T, Laborie LB, Lie SA, Rosendahl K, Engesæter LB. Total hip replacement in young adults with hip dysplasia: age at diagnosis, previous treatment, quality of life, and validation of diagnoses reported to the Norwegian Arthroplasty Register between 1987 and 2007. Acta Orthop. 2011;82(2):149–54.CrossRefPubMedPubMedCentral

Graf R. Classification of hip joint dysplasia by means of sonography. Arch Orthop Trauma Surg. 1984;102(4):248–55.CrossRefPubMed

Theunissen W, van der Steen M, van Douveren F, Witlox AMA, Tolk JJ. Timing of repeat ultrasound examination in treatment of stable developmental dysplasia of the hip. J Pediatr Orthop. 2021;41(4):203–8.CrossRefPubMedPubMedCentral

Roovers EA, Boere-Boonekamp MM, Mostert AK, Castelein RM, Zielhuis GA, Kerkhoff TH. The natural history of developmental dysplasia of the hip: sonographic findings in infants of 1–3 months of age. J Pediatr Orthop B. 2005;14(5):325–30.CrossRefPubMed

Sakkers R, Pollet V. The natural history of abnormal ultrasound findings in hips of infants under six months of age. J Child Orthop. 2018;12(4):302–7.CrossRefPubMedPubMedCentral

Graf R. Hip sonography. Diagnosis and management of infant hip dysplasia. 2nd ed. Berlin: Springer; 2006.

10.

Pollet V, Castelein RM, van de Sande M, Witbreuk M, Mostert AK, Besselaar A, et al. Abduction treatment in stable hip dysplasia does not alter the acetabular growth: results of a randomized clinical trial. Sci Rep. 2020;10(1):9647.CrossRefPubMedPubMedCentral

11.

Wood MK, Conboy V, Benson MK. Does early treatment by abduction splintage improve the development of dysplastic but stable neonatal hips? J Pediatr Orthop. 2000;20(3):302–5.CrossRefPubMed

12.

Rosendahl K, Dezateux C, Fosse KR, Aase H, Aukland SM, Reigstad H, et al. Immediate treatment versus sonographic surveillance for mild hip dysplasia in newborns. Pediatrics. 2010;125(1):e9-16.CrossRefPubMed

13.

Brurås KR, Aukland SM, Markestad T, Sera F, Dezateux C, Rosendahl K. Newborns with sonographically dysplastic and potentially unstable hips: 6-year follow-up of an RCT. Pediatrics. 2011;127(3):e661–6.CrossRefPubMed

14.

Sucato DJ, Johnston CE 2nd, Birch JG, Herring JA, Mack P. Outcome of ultrasonographic hip abnormalities in clinically stable hips. J Pediatr Orthop. 1999;19(6):754–9.CrossRefPubMed

15.

Kim HKW, Beckwith T, De La Rocha A, Zepeda E, Jo CH, Sucato D. Treatment patterns and outcomes of stable hips in infants with ultrasonic dysplasia. J Am Acad Orthop Surg. 2019;27(2):68–74.CrossRefPubMed

16.

Paulussen EMB, Mulder F, Mathijssen NMC, Witlox MA. Active monitoring versus immediate abduction as treatment of stable developmental dysplasia of the hip: a systematic review of the literature. BMJ Open. 2022;12(9):e057906.CrossRefPubMedPubMedCentral

17.

van Bergen CJA, de Witte PB, Willeboordse F, de Geest BL, Foreman-van Drongelen M, Burger BJ, et al. Treatment of centered developmental dysplasia of the hip under the age of 1 year: an evidence-based clinical practice guideline - Part 1. EFORT Open Rev. 2022;7(7):498–505.CrossRefPubMedPubMedCentral

18.

Ömeroğlu H, Köse N, Akceylan A. Success of Pavlik harness treatment decreases in patients ≥ 4 months and in ultrasonographically dislocated hips in developmental dysplasia of the hip. Clin Orthop Relat Res. 2016;474(5):1146–52.CrossRefPubMed

19.

Hakkaart-van Roijen L, van der Linden N, Bouwmans C, Kanters T, Swan Tan S. Kostenhandleiding: Methodologie van kostenonderzoek en referentieprijzen voor economische evaluaties in de gezondheidszorg. 2016.

20.

Mauskopf JA, Sullivan SD, Annemans L, Caro J, Mullins CD, Nuijten M, et al. Principles of good practice for budget impact analysis: report of the ISPOR Task Force on good research practices–budget impact analysis. Value Health. 2007;10(5):336–47.CrossRefPubMed

Title: 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)
Authors: Frederike E. C. M. Mulder
M. Adhiambo Witlox
Carmen D. Dirksen
Pieter Bas de Witte
Suzanne de Vos-Jakobs
Arno M. ten Ham
Melinda M. E. H. Witbreuk
Ralph Sakkers
Magritha (Margret) M. H. P. Foreman-van Drongelen
Simon G. F. Robben
Nina M. C. Mathijssen
TRAM-Trial Consortium
Publication date: 01-12-2023
Publisher: BioMed Central
Keyword: Hip Dysplasia
Published in: BMC Pediatrics / Issue 1/2023
Electronic ISSN: 1471-2431
DOI: https://doi.org/10.1186/s12887-023-04012-2

2024 ASCO Annual Meeting

Springer Medicine

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)

Abstract

Background

Methods

Discussion

Trial registration

2024 ASCO Annual Meeting

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2023

Intranasal analgesia for acute moderate to severe pain in children – a systematic review and meta-analysis

Pulmonary hypertension— a novel phenotypic hypothesis of Kabuki syndrome: a case report and literature review

Clinical characteristics and management of autoimmune enteropathy in children: case reports and literature review

Physical activity interventions for cardiopulmonary fitness in obese children and adolescents: a systematic review and meta-analysis

Cardiovascular fitness is associated with child adiposity at 5 years of age: findings from the ROLO longitudinal birth cohort study

Analysis of the prevalence and related factors of primary hypertension among adolescents and children in the Taicang area