Investigation of the Femoral Shortening Osteotomy in the Developmental Dislocation of the Hip (FSODDH)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hip Dislocation, Femur Head Necrosis

Intervention / Treatment
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* Procedure: Osteotomy
* Procedure: Non-osteotomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Osteotomy<br>Femoral osteotomy are applied in the open treatment of Developmental Dislocation of the Hip （DDH）. | Procedure: Osteotomy<br>* Femoral osteotomy are applied in the open treatment of Developmental Dislocation of the Hip （DDH）.<br>|
| Experimental: Non-osteotomy<br>Femoral osteotomy are not applied in the open treatment of Developmental Dislocation of the Hip （DDH）. | Procedure: Non-osteotomy<br>* Femoral osteotomy are not applied in the open treatment of Developmental Dislocation of the Hip （DDH）.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Femur Head Necrosis | 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. | 2 years | 
| Redislocation | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. | 2 years | 
| Acetabular index | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of operation | The time during the operation measured by minute. | 1 month | 
| Blood loss | The blood lost during the operation measured by milliliter. | 1 month | 
| Cost | The cost of hospitalization. | 1 month | 
| Hospital stays | The days stayed in hospital. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip Dislocation, Congenital, osteotomy, Femur Head Necrosis