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

Primary Purpose

Hip Dislocation, Femur Head Necrosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Osteotomy
Non-osteotomy
Sponsored by
He Jin Peng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Dislocation focused on measuring Hip Dislocation, Congenital, osteotomy, Femur Head Necrosis

Eligibility Criteria

18 Months - 24 Months (Child)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Osteotomy

    Non-osteotomy

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Femur Head Necrosis
    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
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
    Acetabular index
    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

    Duration of operation
    The time during the operation measured by minute.
    Blood loss
    The blood lost during the operation measured by milliliter.
    Cost
    The cost of hospitalization.
    Hospital stays
    The days stayed in hospital.

    Full Information

    First Posted
    December 10, 2015
    Last Updated
    December 16, 2015
    Sponsor
    He Jin Peng
    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
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02633904
    Brief Title
    Investigation of the Femoral Shortening Osteotomy in the Developmental Dislocation of the Hip (FSODDH)
    Acronym
    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

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2015 (undefined)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    December 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    He Jin Peng
    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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Dislocation, Femur Head Necrosis
    Keywords
    Hip Dislocation, Congenital, osteotomy, Femur Head Necrosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Osteotomy
    Arm Type
    Active Comparator
    Arm Description
    Femoral osteotomy are applied in the open treatment of Developmental Dislocation of the Hip (DDH).
    Arm Title
    Non-osteotomy
    Arm Type
    Experimental
    Arm Description
    Femoral osteotomy are not applied in the open treatment of Developmental Dislocation of the Hip (DDH).
    Intervention Type
    Procedure
    Intervention Name(s)
    Osteotomy
    Intervention Description
    Femoral osteotomy are applied in the open treatment of Developmental Dislocation of the Hip (DDH).
    Intervention Type
    Procedure
    Intervention Name(s)
    Non-osteotomy
    Intervention Description
    Femoral osteotomy are not applied in the open treatment of Developmental Dislocation of the Hip (DDH).
    Primary Outcome Measure Information:
    Title
    Femur Head Necrosis
    Description
    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.
    Time Frame
    2 years
    Title
    Redislocation
    Description
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
    Time Frame
    2 years
    Title
    Acetabular index
    Description
    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.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Duration of operation
    Description
    The time during the operation measured by minute.
    Time Frame
    1 month
    Title
    Blood loss
    Description
    The blood lost during the operation measured by milliliter.
    Time Frame
    1 month
    Title
    Cost
    Description
    The cost of hospitalization.
    Time Frame
    1 month
    Title
    Hospital stays
    Description
    The days stayed in hospital.
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Months
    Maximum Age & Unit of Time
    24 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Unilateral DDH,age 18-24month. Tonnis degree I or II. Not receive any open treatment. Exclusion Criteria: Teratologic hip dislocations, 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. Any children with prior hip surgery were excluded from the series. Parents refused further treatment.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Peng J He, Doctor
    Phone
    +86-15071032254
    Email
    619921411@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fan J Shao, Doctor
    Organizational Affiliation
    Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The single-center data will be published in the form of case-control study.
    Citations:
    PubMed Identifier
    19934701
    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.
    Results Reference
    result
    PubMed Identifier
    21643924
    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.
    Results Reference
    result

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

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