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Completed

NCT Number: NCT03096470

Closed Reduction With Anesthesia and no Anesthesia for Developmental Dislocation of the Hip < 6 Months

The purpose of this study is to compare the efficacy of closed reduction with anesthesia and no anesthesia for developmental dislocation of the hip < 6 months

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Key information

Conditions

Developmental Dislocation of the Hip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ectromelia Limb Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Reduction Deformity of Limb

Age range

1 day–6 month

Sex eligibility

All sexes

Study type

Observational

About this study

We treated children (<6 months) with prolonged traction before an attempted closed reduction. And compare the efficacy of closed reduction with anesthesia and no anesthesia for developmental dislocation of the hip. All the patients were followed up for a minimum of 18 months in order to identify any avascular changes in the femoral head. The presence of avascular necrosis was assessed by the criteria of Salter.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patients with GrafⅢ/Ⅳtype DDH diagnosed by ultrasound or if they were IHDI (International Hip Dysplasia Institute) grade III or IV on radiographs，and The infants who were <6 months of age. Patients were followed for at least 18 months,by which time they had either completed treatment with no evidence of requiring further treatment or were treated surgically after failing brace treatment.

Exclusion criteria

  • Infants were excluded if they had multiple congenital abnormalities, had prior treatment in other centres, or showed teratological dislocations. The last were defined as fixed dislocation of the hip in association with either a recognised syndrome or a neurological disorder.

Treatment and study plan

Anesthesia

Procedure

no anesthesia

Primary outcomes

  1. Successful treatment

    Time frame: Through study completion, an average of 2 year.

    obtain and maintain reduction of the hip following bracing with no subsequent surgical treatment

Secondary outcomes

  1. Radiographic evaluation

    Time frame: Through study completion, an average of 2 year.

    Radiographic data collected included evaluation of the Shenton line, the acetabular index, the IHDI grade, the state of ossification of the femoral head, a description of the teardrop, the lateral center-edge angle, and the presence of osteonecrosis of the femoral head

Other outcomes

  1. The complication

    Time frame: Through study completion, an average of 2 year.

    the presence of osteonecrosis of the femoral head， Avascular necrosis was assessed using the criteria of Salter

Sponsors and collaborators

Lead sponsor

The Fuzhou No 2 Hospital

Other

Registry information

Official study title

Clinical Analysis of Two Methods for Closed Reduction of Developmental Dislocation of the Hip by Prolonged Traction < 6 Months----An Multicenter Prospective Observational Study

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 30, 2017
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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