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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: He Jin Peng

Current Primary Outcome:

• 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

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

Original Secondary Outcome: Same as current

Information By: Tongji Hospital

Dates:
Date Received: December 10, 2015
Date Started: December 2015
Date Completion: December 2020
Last Updated: December 16, 2015
Last Verified: December 2015