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Treatment for Mild Hip Dysplasia in Newborns

Primary Purpose

Developmental Dysplasia of the Hip

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Abduction treatment
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Developmental Dysplasia of the Hip focused on measuring therapy, ultrasound, mild dysplasia

Eligibility Criteria

1 Day - 5 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Birth weight > 2500 g
  • Mild hip dysplasia on ultrasound day 1-2
  • Written informed consent given

Exclusion Criteria:

  • Birth weight less than 2500 g and/or severe congenital malformation(s)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Active Sonographic surveillance

    Abduction treatment

    Arm Description

    Follow-up at 1.5 and 3 months (Ultrasound,Clinical examination), at 6 and 12 months (clinical examination, pelvic X-ray)

    Treatment (abduction splint) from 0-6 weeks, follow-up at 1.5 and 3 months (clinical examination and ultrasound) and at 6 and 12 months (clinical examination and pelvic x-ray)

    Outcomes

    Primary Outcome Measures

    The acetabular index (AI), assessed from anterior-posterior pelvic radiographs obtained according to a standardized protocol at age 12 months

    Secondary Outcome Measures

    We also report the proportion of children requiring treatment in the first year of life and its duration, and the proportion of children in each group with radiological ossification delay or dysplasia at one year of age.

    Full Information

    First Posted
    February 11, 2009
    Last Updated
    February 11, 2009
    Sponsor
    University of Bergen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00843258
    Brief Title
    Treatment for Mild Hip Dysplasia in Newborns
    Official Title
    Immediate Treatment Compared With Active Sonographic Surveillance in the Management of Mild Hip Dysplasia in Newborn Infants: A Randomized, Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1998 (undefined)
    Primary Completion Date
    April 2003 (Actual)
    Study Completion Date
    April 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Bergen

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Developmental dysplasia of the hip is the most common musculoskeletal disorder in infancy, with a reported prevalence of 2% of all newborns. Although newborn screening programs based on clinical examination with Ortolani and Barlow tests were introduced in the 1950's and 1960's with early abduction splinting of the 2% testing positive, the prevalence of late cases warranting surgery has remained stable, around one per 1000. This has led to the introduction of ultrasound as an additional diagnostic tool, resulting in treatment rates of until 5-6%. This three fold increase in abduction splinting treatment is partly due to the initiation of treatment of infants in whom mild hip dysplasia but no hip instability has been identified. The benefit of early treatment of mild dysplasia in a hip that is neither dislocated nor dislocatable is unclear. Further, abduction splinting is not without risk, with avascular necrosis being reported in around 1%. The investigators conducted a masked, randomized, controlled trial to examine whether mildly dysplastic but stable or instable hips would benefit from early treatment, as compared to watchful waiting.
    Detailed Description
    140 newborns with stable (not dislocatable or dislocated) but mildly dysplastic hips, born at the Maternity Hospital, Haukeland University Hospital, from 1997 onwards. The newborns will be randomly assigned to one of two groups (number in sealed envelope, see flow chart). Because the newborns are recruited from a high risk group (60% with a positive family history and 35% breech), these risk factors are considered to be equally distributed in the two study groups. Stratification is therefore considered unnecessary. For the controls, treatment will be started at age 1.5 months in cases of persistent dysplasia, i.e. a α-angle <50º, while treatment will be continued in the treatment group if the α-angle is ≤53º. At 3 months, treatment will be discontinued if the α-angle is ≥55º or started if α-angle is<55º. Treatment continued beyond 3 months will be discontinued when the AI is within two standard deviations according to the reference values from Tönnis and Brunken. The study will require randomisation of 128 subjects into two equally sized groups to obtain 80% statistical power to detect a 3º difference of the α-angle. Less than 128 infants will be required to detect a similar difference in AI on radiography. To compensate for an expected rate of ineligibility and loss to follow-up of up to ten per cent, 140 patients will be enrolled. PRACTICAL ISSUES The clinical hip-examinations will be performed at the maternity ward during day 1-3, by a physician with at least 2 years of pediatric experience. The hip joints will be classified as stable, unstable, dislocatable or dislocated. TM has the responsibility for the clinical re-examination prior to enrollement. Ultrasound screening of newborns with increased risk for CDH is common practice at the maternity unit. Newborns eligible for the present study will be recruited from this high-risk group (about 13% of all newborns). To avoid inter-examination bias, all the ultrasound examinations will be performed by one examiner (KR), using a GE RT 3000, 5 MHz linear probe at KKB, and an ATL HDI 3000 machine with a 5 MHz linear probe or an Acuson 10XP, 5 MHz linear probe at the Section of Pediatric Radiology). The ultrasound examinations will be performed according to a modified Graf procedure (Rosendahl), including both hip morphology and hip stability. Newborns with stable hips and a confirmed mild dysplasia on the second ultrasound examination will be re-examined clinically by TM, HR or TA prior to invitation to the study. After written informed consent has been given, the patient will attend the out patient clinic at BKB. A nurse will open the sealed envelope with a random number, and the newborn will enter the control or the treatment group. All data will be exported into SPSS by KR. RTL is the statistical adviser.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Developmental Dysplasia of the Hip
    Keywords
    therapy, ultrasound, mild dysplasia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    140 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active Sonographic surveillance
    Arm Type
    No Intervention
    Arm Description
    Follow-up at 1.5 and 3 months (Ultrasound,Clinical examination), at 6 and 12 months (clinical examination, pelvic X-ray)
    Arm Title
    Abduction treatment
    Arm Type
    Experimental
    Arm Description
    Treatment (abduction splint) from 0-6 weeks, follow-up at 1.5 and 3 months (clinical examination and ultrasound) and at 6 and 12 months (clinical examination and pelvic x-ray)
    Intervention Type
    Device
    Intervention Name(s)
    Abduction treatment
    Other Intervention Name(s)
    Pavlik harness
    Intervention Description
    Abduction treatment with a Frejka's pillow for 6 weeks
    Primary Outcome Measure Information:
    Title
    The acetabular index (AI), assessed from anterior-posterior pelvic radiographs obtained according to a standardized protocol at age 12 months
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    We also report the proportion of children requiring treatment in the first year of life and its duration, and the proportion of children in each group with radiological ossification delay or dysplasia at one year of age.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    5 Days
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Birth weight > 2500 g Mild hip dysplasia on ultrasound day 1-2 Written informed consent given Exclusion Criteria: Birth weight less than 2500 g and/or severe congenital malformation(s)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Karen Rosendahl, PhD
    Organizational Affiliation
    Institute of Surgical Sciences, University of Bergen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    36214650
    Citation
    Dwan K, Kirkham J, Paton RW, Morley E, Newton AW, Perry DC. Splinting for the non-operative management of developmental dysplasia of the hip (DDH) in children under six months of age. Cochrane Database Syst Rev. 2022 Oct 10;10(10):CD012717. doi: 10.1002/14651858.CD012717.pub2.
    Results Reference
    derived
    PubMed Identifier
    21321039
    Citation
    Bruras 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 Mar;127(3):e661-6. doi: 10.1542/peds.2010-2572. Epub 2011 Feb 14.
    Results Reference
    derived
    PubMed Identifier
    20026501
    Citation
    Rosendahl K, Dezateux C, Fosse KR, Aase H, Aukland SM, Reigstad H, Alsaker T, Moster D, Lie RT, Markestad T. Immediate treatment versus sonographic surveillance for mild hip dysplasia in newborns. Pediatrics. 2010 Jan;125(1):e9-16. doi: 10.1542/peds.2009-0357. Epub 2009 Dec 21.
    Results Reference
    derived

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    Treatment for Mild Hip Dysplasia in Newborns

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