Hip DislocationFSODDHNCT02633904
Investigation of the Femoral Shortening Osteotomy in the Developmental Dislocation of the Hip (FSODDH)
A study testing Osteotomy and Non-osteotomy in people with Hip Dislocation and Femur Head Necrosis, run by He Jin Peng.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 months
- Conditions the study is for
- Hip Dislocation, Femur Head Necrosis
- What is being tested?
- Osteotomy and Non-osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Unilateral DDH,age 18-24month.
- Tonnis degree I or II.
- Not receive any open treatment.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigation of the Value of Femoral Shortening Osteotomy During Open Treatment of Developmental Dislocation of the Hip in Waliking Age Group
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.
Read the 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.
- Conditions
- Hip Dislocation, Femur Head Necrosis
- Being tested
- Osteotomy, Non-osteotomy
- Keywords
- Hip Dislocation, Congenital, osteotomy, Femur Head Necrosis
- Medical subject headings
- Hip Dislocation, Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteotomyProcedure or surgery
Femoral osteotomy are applied in the open treatment of Developmental Dislocation of the Hip （DDH）.
Non-osteotomyProcedure or surgery
Femoral osteotomy are not applied in the open treatment of Developmental Dislocation of the Hip （DDH）.
| Study group | Role | What they receive |
|---|---|---|
| Osteotomy | Active comparator | Femoral osteotomy are applied in the open treatment of Developmental Dislocation of the Hip （DDH）. Receives: Procedure: Osteotomy |
| Non-osteotomy | Experimental | Femoral osteotomy are not applied in the open treatment of Developmental Dislocation of the Hip （DDH）. Receives: Procedure: Non-osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Redislocation
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Measured: 2 years
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.
Measured: 2 years
Secondary outcomes (4)
Duration of operation
The time during the operation measured by minute.
Measured: 1 month
Blood loss
The blood lost during the operation measured by milliliter.
Measured: 1 month
Cost
The cost of hospitalization.
Measured: 1 month
Hospital stays
The days stayed in hospital.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip DislocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- He Jin Peng
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan Children's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Guangzhou Women and Children's Medical Center, Wuhan Women and Children's Medical Center, Shenzhen Children's Hospital, Foshan Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor-investigator, He Jin Peng, Tongji Hospital
- Investigators
- Fan J Shao, Doctor, Study director, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633904
- Sponsor's protocol ID
- FSODDH
- Other IDs
- He Jin Peng
- Acronym
- FSODDH
- Status last verified
- Dec 2015
- First submitted
- 10 Dec 2015
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The single-center data will be published in the form of case-control study.
Publications
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.
PubMed 19934701Pospischill 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.
PubMed 21643924
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Value of Femoral Shortening Osteotomy During Open Treatment of Developmental Dislocation of the Hip in Waliking Age Group
- ClinicalTrials.gov ID
- NCT02633904
- Acronym / sponsor ID
- FSODDH / FSODDH
- Conditions
- Hip Dislocation, Femur Head Necrosis
- Keywords
- Hip Dislocation, Congenital, osteotomy, Femur Head Necrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- He Jin PengUniversity, hospital or other
- Collaborators
- Hunan Children's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Guangzhou Women and Children's Medical Center, Wuhan Women and Children's Medical Center, Shenzhen Children's Hospital, Foshan Hospital of Traditional Chinese Medicine
- Study start
- Dec 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteotomy | Active comparator | Procedure: OsteotomyFemoral osteotomy are applied in the open treatment of Developmental Dislocation of the Hip （DDH）. |
| Non-osteotomy | Experimental | Procedure: Non-osteotomyFemoral osteotomy are not applied in the open treatment of Developmental Dislocation of the Hip （DDH）. |
Who may qualify
- Ages
- 18 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Unilateral DDH,age 18-24month.
- Tonnis degree I or II.
- Not receive any open treatment.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsteotomyFemoral osteotomy are applied in the open treatment of Developmental Dislocation of the Hip （DDH）. | Procedure or surgery | Osteotomy |
| Non-osteotomyFemoral osteotomy are not applied in the open treatment of Developmental Dislocation of the Hip （DDH）. | Procedure or surgery | Non-osteotomy |
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.
4 secondary outcomes
Duration of operation
Time frame: 1 month
Blood loss
Time frame: 1 month
Cost
Time frame: 1 month
Hospital stays
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
- Results publication: PubMed 19934701Sankar 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 publication: PubMed 21643924Pospischill 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.
- Individual participant dataSharing planned: Yes. The single-center data will be published in the form of case-control study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fan J Shao, Doctor study director
Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing Osteotomy and Non-osteotomy in people with Hip Dislocation and Femur Head Necrosis, run by He Jin Peng.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peng J He, Doctor (+86-15071032254, 619921411@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Femur Head Necrosis (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02633904, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2015.