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Clinical Trials/NCT02633904
NCT02633904
Unknown
Not Applicable

Investigation of the Value of Femoral Shortening Osteotomy During Open Treatment of Developmental Dislocation of the Hip in Waliking Age Group

He Jin Peng0 sites200 target enrollmentDecember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Dislocation
Sponsor
He Jin Peng
Enrollment
200
Primary Endpoint
Femur Head Necrosis
Last Updated
10 years ago

Overview

Brief Summary

Although older children and high dislocations may be more likely to require a femoral shortening osteotomy, the ultimate decision about whether or not to shorten a given femur should depend on the ease of femoral head reduction in that specific patient. Adding a femoral shortening procedure increases operating time and blood loss, adds a second incision, and necessitates future hardware removal. In addition, an unnecessary femoral shortening osteotomy could overly decrease the soft tissue tension around the joint, putting the hip at risk for redislocation. This study was designed to explore an algorithm based on strict age and radiographic criteria that identify those without the need of femoral osteotomy.

Detailed Description

Developmental dislocation of the hip (DDH) is a common disease in children, and its incidence in China is about 9 ‰.There are many different methods in the treatment of DDH. Although older children and high dislocations may be more likely to require a femoral shortening osteotomy, the ultimate decision about whether or not to shorten a given femur should depend on the ease of femoral head reduction in that specific patient. Adding a femoral shortening procedure increases operating time and blood loss, adds a second incision, and necessitates future hardware removal. In addition, an unnecessary femoral shortening osteotomy could overly decrease the soft tissue tension around the joint, putting the hip at risk for redislocation. This study was designed to explore an algorithm based on strict age and radiographic criteria that identify those without the need of femoral osteotomy. From the investigators'clinical experiences and the published papers, younger patients (\<24 month of age) and low dislocations (Tonnis level I or II) were more likely to avoid a femoral shortening osteotomy.

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
December 2020
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
He Jin Peng
Responsible Party
Sponsor Investigator
Principal Investigator

He Jin Peng

Resident doctor

Tongji Hospital

Eligibility Criteria

Inclusion Criteria

  • Unilateral DDH,age 18-24month.
  • Tonnis degree I or II.
  • Not receive any open treatment.

Exclusion Criteria

  • Teratologic hip dislocations,
  • Patients with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or significant barriers to growth, cerebral palsy, multiple joint contractures disease, dysfunction of liver and kidney , blood disorders, immune deficiency disease and ECG abnormalities.
  • Any children with prior hip surgery were excluded from the series.
  • Parents refused further treatment.

Outcomes

Primary Outcomes

Femur Head Necrosis

Time Frame: 2 years

Radiological evaluation was performed using standard anterior-posterior radiographs of the pelvis. The presence and grade of femur head necrosis was evaluated according to the method presented by Bucholz and Odgen.

Redislocation

Time Frame: 2 years

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

Acetabular index

Time Frame: 2 years

Standardized radiographs have been traditionally used in the surveillance of hip dysplasia by measuring the acetabular index, which is the angle subtended between the Hilgenreiner line and a line drawn from the triradiate cartilage to the lateral edge of the acetabulum.

Secondary Outcomes

  • Blood loss(1 month)
  • Duration of operation(1 month)
  • Cost(1 month)
  • Hospital stays(1 month)

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