Developmental Dislocation of the HipNCT03096470
Closed Reduction With Anesthesia and no Anesthesia for Developmental Dislocation of the Hip < 6 Months
An observational study of Developmental Dislocation of the Hip and Reduction Deformity of Limb, run by The Fuzhou No 2 Hospital.
Trial summary
The purpose of this study is to compare the efficacy of closed reduction with anesthesia and no anesthesia for developmental dislocation of the hip < 6 months Read more about this study
- Who is it for?
- Ages 1 day to 6 months
- Conditions the study is for
- Developmental Dislocation of the Hip, Reduction Deformity of Limb
- What is being tested?
- anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2017to 1 Mar 2017
- Phase
- Observational
- 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 1 day to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: developmental dislocation of the hip（ < 6 months）
Who may be able to join
- The patients with GrafⅢ/Ⅳtype DDH diagnosed by ultrasound or if they were IHDI (International Hip Dysplasia Institute) grade III or IV on radiographs，and The infants who were <6 months of age. Patients were followed for at least 18 months,by which time they had either completed treatment with no evidence of requiring further treatment or were treated surgically after failing brace treatment.
Who cannot join
- Infants were excluded if they had multiple congenital abnormalities, had prior treatment in other centres, or showed teratological dislocations. The last were defined as fixed dislocation of the hip in association with either a recognised syndrome or a neurological disorder.
About this study
Official title: Clinical Analysis of Two Methods for Closed Reduction of Developmental Dislocation of the Hip by Prolonged Traction < 6 Months----An Multicenter Prospective Observational Study
The purpose of this study is to compare the efficacy of closed reduction with anesthesia and no anesthesia for developmental dislocation of the hip < 6 months
Read the detailed description
We treated children (<6 months) with prolonged traction before an attempted closed reduction. And compare the efficacy of closed reduction with anesthesia and no anesthesia for developmental dislocation of the hip. All the patients were followed up for a minimum of 18 months in order to identify any avascular changes in the femoral head. The presence of avascular necrosis was assessed by the criteria of Salter.
- Being tested
- anesthesia
- Medical subject headings
- Ectromelia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anesthesiaProcedure or surgery
no anesthesia
| Study group | Role | What they receive |
|---|---|---|
| anesthesia | The children were treated with closed reduction with anesthesia after prolonged traction Receives: Procedure: anesthesia | |
| No anesthesia | The children were treated with closed reduction with no anesthesia after prolonged traction Receives: Procedure: anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful treatment
obtain and maintain reduction of the hip following bracing with no subsequent surgical treatment
Measured: Through study completion, an average of 2 year.
Secondary outcomes (1)
Radiographic evaluation
Radiographic data collected included evaluation of the Shenton line, the acetabular index, the IHDI grade, the state of ossification of the femoral head, a description of the teardrop, the lateral center-edge angle, and the presence of osteonecrosis of the femoral head
Measured: Through study completion, an average of 2 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start1 Mar 2017
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Developmental Dislocation of the HipStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Fuzhou No 2 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shunyou Chen, The Fuzhou No 2 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096470
- Sponsor's protocol ID
- SChen1
- Status last verified
- Mar 2017
- First submitted
- 10 Mar 2017
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Cashman JP, Round J, Taylor G, Clarke NM. The natural history of developmental dysplasia of the hip after early supervised treatment in the Pavlik harness. A prospective, longitudinal follow-up. J Bone Joint Surg Br. 2002 Apr;84(3):418-25. doi: 10.1302/0301-620x.84b3.12230.
PubMed 12002504Upasani VV, Bomar JD, Matheney TH, Sankar WN, Mulpuri K, Price CT, Moseley CF, Kelley SP, Narayanan U, Clarke NM, Wedge JH, Castaneda P, Kasser JR, Foster BK, Herrera-Soto JA, Cundy PJ, Williams N, Mubarak SJ. Evaluation of Brace Treatment for Infant Hip Dislocation in a Prospective Cohort: Defining the Success Rate and Variables Associated with Failure. J Bone Joint Surg Am. 2016 Jul 20;98(14):1215-21. doi: 10.2106/JBJS.15.01018.
PubMed 27440570Fukiage K, Futami T, Ogi Y, Harada Y, Shimozono F, Kashiwagi N, Takase T, Suzuki S. Ultrasound-guided gradual reduction using flexion and abduction continuous traction for developmental dysplasia of the hip: a new method of treatment. Bone Joint J. 2015 Mar;97-B(3):405-11. doi: 10.1302/0301-620X.97B3.34287.
PubMed 25737526Yamada N, Maeda S, Fujii G, Kita A, Funayama K, Kokubun S. Closed reduction of developmental dislocation of the hip by prolonged traction. J Bone Joint Surg Br. 2003 Nov;85(8):1173-7. doi: 10.1302/0301-620x.85b8.14208.
PubMed 14653603
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Analysis of Two Methods for Closed Reduction of Developmental Dislocation of the Hip by Prolonged Traction < 6 Months----An Multicenter Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03096470
- Acronym / sponsor ID
- SChen1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Fuzhou No 2 HospitalUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 30 Mar 2017 (actual)
- 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.
The purpose of this study is to compare the efficacy of closed reduction with anesthesia and no anesthesia for developmental dislocation of the hip < 6 months
Detailed description
We treated children (<6 months) with prolonged traction before an attempted closed reduction. And compare the efficacy of closed reduction with anesthesia and no anesthesia for developmental dislocation of the hip. All the patients were followed up for a minimum of 18 months in order to identify any avascular changes in the femoral head. The presence of avascular necrosis was assessed by the criteria of Salter.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anesthesia | – | Procedure: anesthesiaThe children were treated with closed reduction with anesthesia after prolonged traction |
| No anesthesia | – | Procedure: anesthesiaThe children were treated with closed reduction with no anesthesia after prolonged traction |
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- developmental dislocation of the hip（ < 6 months）
Key inclusion criteria (1 listed)
- The patients with GrafⅢ/Ⅳtype DDH diagnosed by ultrasound or if they were IHDI (International Hip Dysplasia Institute) grade III or IV on radiographs，and The infants who were <6 months of age. Patients were followed for at least 18 months,by which time they had either completed treatment with no evidence of requiring further treatment or were treated surgically after failing brace treatment.
Key exclusion criteria (1 listed)
- Infants were excluded if they had multiple congenital abnormalities, had prior treatment in other centres, or showed teratological dislocations. The last were defined as fixed dislocation of the hip in association with either a recognised syndrome or a neurological disorder.
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 |
|---|---|---|
| anesthesiano anesthesia | Procedure or surgery | No anesthesia, anesthesia |
Primary outcome
Successful treatment
Time frame: Through study completion, an average of 2 year.
obtain and maintain reduction of the hip following bracing with no subsequent surgical treatment
1 secondary outcome
Radiographic evaluation
Time frame: Through study completion, an average of 2 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Background: PubMed 12002504Cashman JP, Round J, Taylor G, Clarke NM. The natural history of developmental dysplasia of the hip after early supervised treatment in the Pavlik harness. A prospective, longitudinal follow-up. J Bone Joint Surg Br. 2002 Apr;84(3):418-25. doi: 10.1302/0301-620x.84b3.12230.
- Background: PubMed 27440570Upasani VV, Bomar JD, Matheney TH, Sankar WN, Mulpuri K, Price CT, Moseley CF, Kelley SP, Narayanan U, Clarke NM, Wedge JH, Castaneda P, Kasser JR, Foster BK, Herrera-Soto JA, Cundy PJ, Williams N, Mubarak SJ. Evaluation of Brace Treatment for Infant Hip Dislocation in a Prospective Cohort: Defining the Success Rate and Variables Associated with Failure. J Bone Joint Surg Am. 2016 Jul 20;98(14):1215-21. doi: 10.2106/JBJS.15.01018.
- Background: PubMed 25737526Fukiage K, Futami T, Ogi Y, Harada Y, Shimozono F, Kashiwagi N, Takase T, Suzuki S. Ultrasound-guided gradual reduction using flexion and abduction continuous traction for developmental dysplasia of the hip: a new method of treatment. Bone Joint J. 2015 Mar;97-B(3):405-11. doi: 10.1302/0301-620X.97B3.34287.
- Background: PubMed 14653603Yamada N, Maeda S, Fujii G, Kita A, Funayama K, Kokubun S. Closed reduction of developmental dislocation of the hip by prolonged traction. J Bone Joint Surg Br. 2003 Nov;85(8):1173-7. doi: 10.1302/0301-620x.85b8.14208.
- Individual participant dataSharing planned: Yes
Related trials for Developmental Dislocation of the Hip
Not yet recruiting
Improving Neonatal Hip Screening With Artificial Intelligence
Developmental Dysplasia of Hip
Not yet recruiting
8 vs 12 Weeks: A Pavlik Harness Trial
Developmental Dysplasia of Hip, DDH
Recruiting
Clinical Outcomes of Primary Cementless Total Hip Arthroplasty Using the Collarless Actis Stem
Osteoarthritis, Hip, Femur Head Necrosis
Not yet recruiting
Manual Intervention and Congenital Hip Dysplasia in Infants
Developmental Dysplasia of the Hip (DDH), Congenital Hip Dysplasia
RecruitingObservational study
Computer-Assisted Comparison of Hip Socket Volume and Surface Shape After Pediatric Acetabular Osteotomies
Developmental Dysplasia of the Hip (DDH), Developmental Dysplasia of the Hip
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Dislocation of the Hip and Reduction Deformity of Limb, run by The Fuzhou No 2 Hospital.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Mar 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful treatment (time frame: Through study completion, an average of 2 year.). 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 NCT03096470, which also lists 4 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 30 Mar 2017; AzTrials last refreshed its copy on 28 Oct 2026.