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

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

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

Study Overview

• Status: Completed
• Conditions: Developmental Dislocation of the Hip; Reduction Deformity of Limb
• Intervention / Treatment: Procedure: anesthesia

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 Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 6 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

developmental dislocation of the hip（ < 6 months）

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
anesthesia; The children were treated with closed reduction with anesthesia after prolonged traction	Procedure: anesthesia; no anesthesia
No anesthesia; The children were treated with closed reduction with no anesthesia after prolonged traction	Procedure: anesthesia; no anesthesia

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic evaluation	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	Through study completion, an average of 2 year.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The complication	the presence of osteonecrosis of the femoral head， Avascular necrosis was assessed using the criteria of Salter	Through study completion, an average of 2 year.

Collaborators and Investigators

• Sponsor: The Fuzhou No 2 Hospital

Publications and helpful links

General Publications

• Cashman JP, Round J, Taylor G, Clarke NM. The natural history of developmental dysplasia of the hip after early supervised treatment in the Pavlik harness. A prospective, longitudinal follow-up. J Bone Joint Surg Br. 2002 Apr;84(3):418-25. doi: 10.1302/0301-620x.84b3.12230.
• Upasani VV, Bomar JD, Matheney TH, Sankar WN, Mulpuri K, Price CT, Moseley CF, Kelley SP, Narayanan U, Clarke NM, Wedge JH, Castaneda P, Kasser JR, Foster BK, Herrera-Soto JA, Cundy PJ, Williams N, Mubarak SJ. Evaluation of Brace Treatment for Infant Hip Dislocation in a Prospective Cohort: Defining the Success Rate and Variables Associated with Failure. J Bone Joint Surg Am. 2016 Jul 20;98(14):1215-21. doi: 10.2106/JBJS.15.01018.
• Fukiage K, Futami T, Ogi Y, Harada Y, Shimozono F, Kashiwagi N, Takase T, Suzuki S. Ultrasound-guided gradual reduction using flexion and abduction continuous traction for developmental dysplasia of the hip: a new method of treatment. Bone Joint J. 2015 Mar;97-B(3):405-11. doi: 10.1302/0301-620X.97B3.34287.
• Yamada N, Maeda S, Fujii G, Kita A, Funayama K, Kokubun S. Closed reduction of developmental dislocation of the hip by prolonged traction. J Bone Joint Surg Br. 2003 Nov;85(8):1173-7. doi: 10.1302/0301-620x.85b8.14208.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): March 1, 2017
• Study Completion (ACTUAL): March 1, 2017

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: March 29, 2017
• First Posted (ACTUAL): March 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 30, 2017
• Last Update Submitted That Met QC Criteria: March 29, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Hip Injuries; Hip Dislocation; Joint Dislocations; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: SChen1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No