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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2018

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.

Interventions

  • Procedure: Osteotomy
    • Femoral osteotomy are applied in the open treatment of Developmental Dislocation of the Hip (DDH).
  • Procedure: Non-osteotomy
    • Femoral osteotomy are not applied in the open treatment of Developmental Dislocation of the Hip (DDH).

Arms, Groups and Cohorts

  • Active Comparator: Osteotomy
    • Femoral osteotomy are applied in the open treatment of Developmental Dislocation of the Hip (DDH).
  • Experimental: Non-osteotomy
    • Femoral osteotomy are not applied in the open treatment of Developmental Dislocation of the Hip (DDH).

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Months

Maximum Age: 24 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • He Jin Peng
  • Collaborator
    • Hunan Children’s Hospital
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: He Jin Peng, Resident doctor – Tongji Hospital
  • Overall Official(s)
    • Fan J Shao, Doctor, Study Director, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Overall Contact(s)
    • Peng J He, Doctor, +86-15071032254, 619921411@qq.com

Citations Reporting on Results

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.

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.

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