Clinical trial NCT02633904: Investigation of the Femoral Shortening Osteotomy in the Developmental Dislocation of the Hip (FSODDH)
Official title: Investigation of the Value of Femoral Shortening Osteotomy During Open Treatment of Developmental Dislocation of the Hip in Waliking Age Group
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Dislocation
Femur Head Necrosis
Keywords: Hip Dislocation
Congenital
osteotomy
Femur Head Necrosis
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Hunan Children's Hospital
name: Wuhan Union Hospital, China
name: Guangzhou Women and Children's Medical Center
name: Wuhan Women and Children's Medical Center
name: Shenzhen Children's Hospital
name: Foshan Hospital of Traditional Chinese Medicine
First posted: 2015-12-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Femur Head Necrosis
timeFrame: 2 years
measure: Redislocation
timeFrame: 2 years
measure: Acetabular index
timeFrame: 2 years
Secondary outcomes:
measure: Duration of operation
timeFrame: 1 month
measure: Blood loss
timeFrame: 1 month
measure: Cost
timeFrame: 1 month
measure: Hospital stays
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
name: Fan J Shao, Doctor
role: STUDY_DIRECTOR
References:
citation: Sankar WN, Tang EY, Moseley CF. Predictors of the need for femoral shortening osteotomy during open treatment of developmental dislocation of the hip. J Pediatr Orthop. 2009 Dec;29(8):868-71. doi: 10.1097/BPO.0b013e3181c29cb2.
citation: Pospischill R, Weninger J, Ganger R, Altenhuber J, Grill F. Does open reduction of the developmental dislocated hip increase the risk of osteonecrosis? Clin Orthop Relat Res. 2012 Jan;470(1):250-60. doi: 10.1007/s11999-011-1929-4. Epub 2011 Jun 4.