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

Completed

• Conditions: Reduction Deformity of Limb; Developmental Dislocation of the Hip
• Interventions: Procedure: anesthesia

• Registration Number: NCT03096470
• Lead Sponsor: The Fuzhou No 2 Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2017-03
• Study Start: 2017-03-01
• Primary Completion: 2017-03-01
• Study Completion: 2017-03-01
• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-03-29
• Last Update Submitted: 2017-03-29
• Study First Posted: 2017-03-30
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
anesthesia	anesthesia	The children were treated with closed reduction with anesthesia after prolonged traction
No anesthesia	anesthesia	The children were treated with closed reduction with no anesthesia after prolonged traction

Primary Outcome Measures

Name	Time	Method
Successful treatment	Through study completion, an average of 2 year.	obtain and maintain reduction of the hip following bracing with no subsequent surgical treatment

Secondary Outcome Measures

Name	Time	Method
Radiographic evaluation	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