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
About this trial
This is an interventional treatment trial for Hip Dislocation focused on measuring Hip Dislocation, Congenital, osteotomy, Femur Head Necrosis
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.
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
NCT ID
NCT02633904
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
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
Learn more about this trial
Investigation of the Femoral Shortening Osteotomy in the Developmental Dislocation of the Hip (FSODDH)
We'll reach out to this number within 24 hrs