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

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ClinicalTrials.gov Identifier: NCT02633904
Recruitment Status : Not yet recruiting
First Posted : December 17, 2015
Last Update Posted : December 17, 2015
Sponsor:
Collaborators:
Hunan Children's Hospital
Wuhan Union Hospital, China
Guangzhou Women and Children's Medical Center
Wuhan Women and Children's Medical Center
Shenzhen Children's Hospital
Foshan Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
He Jin Peng, Tongji Hospital

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.

Condition or disease Intervention/treatment Phase
Hip Dislocation Femur Head Necrosis Procedure: Osteotomy Procedure: Non-osteotomy Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Investigation of the Value of Femoral Shortening Osteotomy During Open Treatment of Developmental Dislocation of the Hip in Waliking Age Group
Study Start Date : December 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Osteotomy
Femoral osteotomy are applied in the open treatment of Developmental Dislocation of the Hip (DDH).
Procedure: 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).
Procedure: Non-osteotomy
Femoral osteotomy are not applied in the open treatment of Developmental Dislocation of the Hip (DDH).



Primary Outcome Measures :
  1. 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.

  2. Redislocation [ Time Frame: 2 years ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

  3. 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 Outcome Measures :
  1. Duration of operation [ Time Frame: 1 month ]
    The time during the operation measured by minute.

  2. Blood loss [ Time Frame: 1 month ]
    The blood lost during the operation measured by milliliter.

  3. Cost [ Time Frame: 1 month ]
    The cost of hospitalization.

  4. Hospital stays [ Time Frame: 1 month ]
    The days stayed in hospital.



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Ages Eligible for Study:   18 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633904


Contacts
Contact: Peng J He, Doctor +86-15071032254 619921411@qq.com

Sponsors and Collaborators
He Jin Peng
Hunan Children's Hospital
Wuhan Union Hospital, China
Guangzhou Women and Children's Medical Center
Wuhan Women and Children's Medical Center
Shenzhen Children's Hospital
Foshan Hospital of Traditional Chinese Medicine
Investigators
Study Director: Fan J Shao, Doctor Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Publications of Results:
Responsible Party: He Jin Peng, Resident doctor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT02633904     History of Changes
Other Study ID Numbers: FSODDH
He Jin Peng ( Registry Identifier: Tongji Hospital )
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The single-center data will be published in the form of case-control study.

Keywords provided by He Jin Peng, Tongji Hospital:
Hip Dislocation
Congenital
osteotomy
Femur Head Necrosis

Additional relevant MeSH terms:
Necrosis
Joint Dislocations
Femur Head Necrosis
Hip Dislocation
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Osteonecrosis
Hip Injuries