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

Developmental Dislocation of the Hip Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03096470
• Other study ID #: SChen1
• Status: Completed
• Phase: N/A
• First received: March 10, 2017
• Last updated: March 29, 2017
• Start date: March 1, 2017
• Est. completion date: March 1, 2017

Study information

• Verified date: March 2017
• Source: The Fuzhou No 2 Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• The patients with Graf?/?type 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.

Related Conditions & MeSH terms

• Developmental Dislocation of the Hip
• Dislocations
• Hip Dislocation
• Reduction Deformity of Limb

Intervention

Procedure:
• anesthesia
no anesthesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Fuzhou No 2 Hospital

References & Publications (4)

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. — View Citation

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. — View Citation

Upasani VV, Bomar JD, Matheney TH, Sankar WN, Mulpuri K, Price CT, Moseley CF, Kelley SP, Narayanan U, Clarke NM, Wedge JH, Castañeda 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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	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.