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

Not Applicable

• Conditions: Femur Head Necrosis; Hip Dislocation
• Interventions: Procedure: Non-osteotomy; Procedure: Osteotomy

• Registration Number: NCT02633904
• Lead Sponsor: He Jin Peng

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.

Study Timeline

• Status Verified: 2015-12
• Study Start: 2015-12
• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2015-12-16
• Last Update Submitted: 2015-12-16
• Study First Posted: 2015-12-17
• Last Update Posted: 2015-12-17
• Primary Completion: 2018-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

1. Teratologic hip dislocations,
2. 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.
3. Any children with prior hip surgery were excluded from the series.
4. Parents refused further treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-osteotomy	Non-osteotomy	Femoral osteotomy are not applied in the open treatment of Developmental Dislocation of the Hip （DDH）.
Osteotomy	Osteotomy	Femoral osteotomy are applied in the open treatment of Developmental Dislocation of the Hip （DDH）.

Primary Outcome Measures

Name	Time	Method
Femur Head Necrosis	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	2 years	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Acetabular index	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 Outcome Measures

Name	Time	Method
Cost	1 month	The cost of hospitalization.
Blood loss	1 month	The blood lost during the operation measured by milliliter.
Duration of operation	1 month	The time during the operation measured by minute.
Hospital stays	1 month	The days stayed in hospital.