Clinical trial NCT03096470: Closed Reduction With Anesthesia and no Anesthesia for Developmental Dislocation of the Hip < 6 Months
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Developmental Dislocation of the Hip
Reduction Deformity of Limb
Lead sponsor: The Fuzhou No 2 Hospital
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: developmental dislocation of the hip（ \< 6 months）

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Successful treatment
timeFrame: Through study completion, an average of 2 year.
Secondary outcomes:
measure: Radiographic evaluation
timeFrame: Through study completion, an average of 2 year.
Other outcomes:
measure: The complication
timeFrame: Through study completion, an average of 2 year.
Locations:
Study officials:
References:
citation: 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.
citation: 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.
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.
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. doi: 10.1302/0301-620x.85b8.14208.