Femoral Neck FracturesPFNFNCT02803983
Pediatric Hip Plate Versus Cannulated Screw in Pediatric Femoral Neck Fracture
An observational study of Femoral Neck Fractures, run by The Fuzhou No 2 Hospital.
Trial summary
The purpose of this study is to compare the early postoperative radiologic and clinical outcomes of pediatric hip plate and cannulated screw fixation in pediatric femoral neck fracture (Delbet type II and Delbet type III). Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- Pediatric hip plate and Cannulated screw
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2016
- 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 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatric femoral neck fracture(Delbet type II and Delbet type III)
Who may be able to join
- Patients with fractures that met these criteria, underwent definitive surgery and had complete clinical and radiographic follow up until fracture union at either institution were included in this study.
Who cannot join
- Pathologic fractures, and fractures in patients with osteogenesis imperfecta, neuromuscular disorders or any systemic disease that was associated with a predisposition to fractures or altered fracture healing were excluded.
About this study
Official title: An Multicenter Prospective Observational Study to Pediatric Hip Plate Versus Cannulated Screw in Pediatric Femoral Neck Fracture (Delbet Type II and III)
The purpose of this study is to compare the early postoperative radiologic and clinical outcomes of pediatric hip plate and cannulated screw fixation in pediatric femoral neck fracture (Delbet type II and Delbet type III).
Read the detailed description
The children aged 3 to 14 years with femoral neck fracture that were treated with pediatric hip plate and cannulated screw fixation.
- Conditions
- Femoral Neck Fractures
- Being tested
- Pediatric hip plate, Cannulated screw
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric hip plateProcedure or surgery
Children were treated with pediatric hip plate.
Cannulated screwProcedure or surgery
Children were treated with cannulated screw.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric hip plate | The children were treated with pediatric hip plate. Receives: Procedure: Pediatric hip plate | |
| Cannulated screw | The children were treated with cannulated screw. Receives: Procedure: Cannulated screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic union
The time of radiographic union.
Measured: Through study completion, an average of 0.5 year.
Secondary outcomes (1)
The Ratliff classification standard score
Ratliff classification standard score was administered to determine the pain, function, activity and radiographic change.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2016
- Study completionJun 2016
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 Femoral Neck FracturesStudies 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
- NCT02803983
- Sponsor's protocol ID
- SChen
- Acronym
- PFNF
- Status last verified
- Jun 2016
- First submitted
- 2 Jun 2016
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
RATLIFF AH. Fractures of the neck of the femur in children. J Bone Joint Surg Br. 1962 Aug;44-B:528-42. doi: 10.1302/0301-620X.44B3.528. No abstract available.
PubMed 14038616Joeris A, Audige L, Ziebarth K, Slongo T. The Locking Compression Paediatric Hip Plate: technical guide and critical analysis. Int Orthop. 2012 Nov;36(11):2299-306. doi: 10.1007/s00264-012-1643-1. Epub 2012 Aug 26.
PubMed 22923267
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Multicenter Prospective Observational Study to Pediatric Hip Plate Versus Cannulated Screw in Pediatric Femoral Neck Fracture (Delbet Type II and III)
- ClinicalTrials.gov ID
- NCT02803983
- Acronym / sponsor ID
- PFNF / SChen
- Conditions
- Femoral Neck Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Fuzhou No 2 HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Jun 2016 (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.
The purpose of this study is to compare the early postoperative radiologic and clinical outcomes of pediatric hip plate and cannulated screw fixation in pediatric femoral neck fracture (Delbet type II and Delbet type III).
Detailed description
The children aged 3 to 14 years with femoral neck fracture that were treated with pediatric hip plate and cannulated screw fixation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric hip plate | – | Procedure: Pediatric hip plateThe children were treated with pediatric hip plate. |
| Cannulated screw | – | Procedure: Cannulated screwThe children were treated with cannulated screw. |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric femoral neck fracture(Delbet type II and Delbet type III)
Key inclusion criteria (1 listed)
- Patients with fractures that met these criteria, underwent definitive surgery and had complete clinical and radiographic follow up until fracture union at either institution were included in this study.
Key exclusion criteria (1 listed)
- Pathologic fractures, and fractures in patients with osteogenesis imperfecta, neuromuscular disorders or any systemic disease that was associated with a predisposition to fractures or altered fracture healing were excluded.
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 |
|---|---|---|
| Pediatric hip plateChildren were treated with pediatric hip plate. | Procedure or surgery | Pediatric hip plate |
| Cannulated screwChildren were treated with cannulated screw. | Procedure or surgery | Cannulated screw |
Primary outcome
Radiographic union
Time frame: Through study completion, an average of 0.5 year.
The time of radiographic union.
1 secondary outcome
The Ratliff classification standard score
Time frame: Through study completion, an average of 1 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 22 Feb 2018.
- Results publication: PubMed 14038616RATLIFF AH. Fractures of the neck of the femur in children. J Bone Joint Surg Br. 1962 Aug;44-B:528-42. doi: 10.1302/0301-620X.44B3.528. No abstract available.
- Results publication: PubMed 22923267Joeris A, Audige L, Ziebarth K, Slongo T. The Locking Compression Paediatric Hip Plate: technical guide and critical analysis. Int Orthop. 2012 Nov;36(11):2299-306. doi: 10.1007/s00264-012-1643-1. Epub 2012 Aug 26.
- Individual participant dataSharing planned: No
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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.
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 Femoral Neck Fractures, 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 22 Feb 2018. 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?
Radiographic union (time frame: Through study completion, an average of 0.5 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 NCT02803983, 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 22 Feb 2018.