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. 2022 Oct 10;2022(10):CD012717. doi: 10.1002/14651858.CD012717.pub2

NCT02885831.

Study name Public title: Early abduction splintage on stable hips in infants with developmental dysplasia of the hip (DDH)
Official title: Early abduction splintage on stable hips in infants with developmental dysplasia of the hip: improvement or overtreatment?
Methods Prospective cohort
Participants 90 babies
Inclusion criteria

  1. Term infants

  2. Infants between 1 and 2 months of age at inclusion

  3. Clinically stable hip

  4. Pathological ultrasonography: pubo‐femoral distance > 6 mm and bony rim percentage < 50%

  5. Non‐objection of the family


Exclusion criteria

  1. Clinically unstable hip

  2. Normal ultrasonography

  3. Neuro‐orthopedic disease

  4. Postural deformity of the pelvis

  5. Participation refusal
Interventions  

  1. Abduction splintage (n = 45): treatment by abduction splintage, 24 hours a day and 7 days a week, for 2 months. Other Name: Neut supple hip abduction cushion without bone. Sonographic, clinical and radiographic surveillance

  2. Surveillance (n = 45): no treatment by abduction splintage. Sonographic, clinical and radiographic surveillance


 
Outcomes Primary outcome

  1. Normal or abnormal hip ultrasound (time frame: 2 months). A normal or abnormal hip ultrasound will be base on two outcomes:

    1. Pubo‐femoral distance (ultrasonographic measurement): distance between the pubic bone and the cartilaginous femoral head, considered as normal if lower than 6 mm

    2. Bony rim percentage (ultrasonographic measurement): percentage of the cartilaginous femoral head covered by the acetabular roof, considered as normal if higher than 50% (or equal to 50%)


Data of pubo‐femoral distance and bony rim percentage will be pooled to determine if the ultrasound is normal or not for each baby. If one out of two is abnormal, ultrasound is considered abnormal. Statistics will be based on this qualitative value: normal or abnormal ultrasound
Starting date December 2016 to December 2020
Contact information Name: Dr Camille Printempts
Address: University Hospital, Brest
Email address: camille.printemps@chu‐brest.fr
Notes Comment: We contacted Dr Printemps in February 2019, who informed us that they are still recruiting.