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

NCT03096470 | Completed DMC

• 1 other identifier: SChen1
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Developmental Dislocation of the Hip; Reduction Deformity of Limb

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Radiographic evaluation

  Through study completion, an average of 2 year.

Other Outcomes (1)

• The complication

  Through study completion, an average of 2 year.

Study Arms (2)

anesthesia

The children were treated with closed reduction with anesthesia after prolonged traction

Procedure: anesthesia

No anesthesia

The children were treated with closed reduction with no anesthesia after prolonged traction

Procedure: anesthesia

Interventions

anesthesia PROCEDURE

no anesthesia

No anesthesia; anesthesia

Eligibility Criteria

• Age: 1 Day - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

developmental dislocation of the hip（ \< 6 months）

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Fuzhou No 2 Hospital: lead

Related 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. doi: 10.1302/0301-620x.84b3.12230.

  PMID: 12002504 BACKGROUND

• 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.

  PMID: 27440570 BACKGROUND

• 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.

  PMID: 25737526 BACKGROUND

• 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.

  PMID: 14653603 BACKGROUND

MeSH Terms

Conditions

Ectromelia

Interventions

Anesthesia

Condition Hierarchy (Ancestors)

Limb Deformities, Congenital; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director,Orthopaedics

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 30, 2017
• Study Start: March 1, 2017
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 30, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share