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

He Jin Peng

Status: Unknown

Conditions: Hip Dislocation; Femur Head Necrosis

Treatments: Procedure: Non-osteotomy; Procedure: Osteotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02633904

FSODDH

He Jin Peng (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 24 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Osteotomy

Active Comparator group

Description:

Femoral osteotomy are applied in the open treatment of Developmental Dislocation of the Hip （DDH）.

Treatment:

Procedure: Osteotomy

Non-osteotomy

Experimental group

Description:

Femoral osteotomy are not applied in the open treatment of Developmental Dislocation of the Hip （DDH）.

Treatment:

Procedure: Non-osteotomy