Femoral Neck FractureNCT03550079
Fixation for the Treatment of Femoral Neck Fractures
A study testing fixation in people with Femoral Neck Fracture, run by Hebei Medical University Third Hospital at 1 site in China.
Trial summary
The femoral neck fracture is the most prevalent injuries which commonly encountered among older people with high mortality, morbidity and young fit healthy ones who subjected to high-energy trauma . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Femoral Neck Fracture
- What is being tested?
- fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2017to 30 Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- closed femoral neck fracture
- no fractures at other sites
- surgical treatment with cannulated compression screws or PFNA
- follow-up time greater than 1 years.
Who cannot join
- the absence of severe cognitive dysfunction,
- the presence of a pathological femoral neck fracture
- previous femoral neck fracture, treated with other internal fixations and surgical treatment with open reduction.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Chen Wei
About this study
Official title: the Fixation Method for the Treatment of Femoral Neck Fractures
The femoral neck fracture is the most prevalent injuries which commonly encountered among older people with high mortality, morbidity and young fit healthy ones who subjected to high-energy trauma . Non-union or avascular necrosis of femoral neck fracture which lead to loss of labor capacity and death, is the most commonly occurred complication and results in considerable burden for family. The treatment is difficult and challenging, and to minimize the negative results such as limited mobilization or other complications, it is essential to take active prevention and appropriate treatment depending on fracture pattern and patients' characteristics as early as possible. However, current implant selections for femoral neck fractures remain a topic of greater interest and controversy, and vary substantially from each other .
Read the detailed description
The incidence of femoral neck fracture accounts for 3.6% of all fractures, is the most prevalent injuries which commonly encountered among older people with high mortality, morbidity and young fit healthy ones who subjected to high-energy trauma . Non-union or avascular necrosis of femoral neck fracture which lead to loss of labor capacity and death, is the most commonly occurred complication and results in considerable burden for family. The treatment is difficult and challenging, and to minimize the negative results such as limited mobilization or other complications, it is essential to take active prevention and appropriate treatment depending on fracture pattern and patients' characteristics as early as possible. However, current implant selections for femoral neck fractures remain a topic of greater interest and controversy, and vary substantially from each other depending on the extent of displacement, fracture configuration, physiological age of the patient, bone quality or other relative factors. Nonoperative management is considered only when patients are seriously ill or presented with excessive surgical risk.
- Conditions
- Femoral Neck Fracture
- Being tested
- fixation
- 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.
fixationProcedure or surgery
treated with different fixation method
| Study group | Role | What they receive |
|---|---|---|
| three screws fixation | Experimental | femoral neck fractures were fixed with three converted screws Receives: Procedure: fixation |
| four screws fixation | Experimental | femoral neck fractures were fixed with four screws Receives: Procedure: fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
outcome measure were evaluated by femoral neck shortening with X rays
femoral neck shortening after 1 year with radiology measure,
Measured: up to 12 months
Secondary outcomes (3)
nonunion
the number of nonunion at the end of follow up in patients
Measured: up to 12 months
screw-exit
screw-exit afer 1 year with X rays in all patients
Measured: up to 12 months
cut-out
cut-out of the screw evaluating with x rays in all patients
Measured: up t 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start1 Oct 2017
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Femoral Neck FractureStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zhiyong Hou, MD, Study director, Hebei Medical University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550079
- Sponsor's protocol ID
- 11156458
- Status last verified
- Jun 2018
- First submitted
- 23 Apr 2018
- Last updated
- 13 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the data should be allowed by Zhang Yingze
Publications
Guo J, Dong W, Yin B, Jin L, Lin Z, Hou Z, Zhang Y. Intramedullary nails with cannulated screw fixation for the treatment of unstable femoral neck fractures. J Int Med Res. 2019 Feb;47(2):557-568. doi: 10.1177/0300060518816185. Epub 2018 Dec 11.
PubMed 30526163
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Fixation Method for the Treatment of Femoral Neck Fractures
- ClinicalTrials.gov ID
- NCT03550079
- Acronym / sponsor ID
- 11156458
- Conditions
- Femoral Neck Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hebei Medical University Third HospitalUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 8 Jun 2018 (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 femoral neck fracture is the most prevalent injuries which commonly encountered among older people with high mortality, morbidity and young fit healthy ones who subjected to high-energy trauma . Non-union or avascular necrosis of femoral neck fracture which lead to loss of labor capacity and death, is the most commonly occurred complication and results in considerable burden for family. The treatment is difficult and challenging, and to minimize the negative results such as limited mobilization or other complications, it is essential to take active prevention and appropriate treatment depending on fracture pattern and patients' characteristics as early as possible. However, current implant selections for femoral neck fractures remain a topic of greater interest and controversy, and vary substantially from each other .
Detailed description
The incidence of femoral neck fracture accounts for 3.6% of all fractures, is the most prevalent injuries which commonly encountered among older people with high mortality, morbidity and young fit healthy ones who subjected to high-energy trauma . Non-union or avascular necrosis of femoral neck fracture which lead to loss of labor capacity and death, is the most commonly occurred complication and results in considerable burden for family. The treatment is difficult and challenging, and to minimize the negative results such as limited mobilization or other complications, it is essential to take active prevention and appropriate treatment depending on fracture pattern and patients' characteristics as early as possible. However, current implant selections for femoral neck fractures remain a topic of greater interest and controversy, and vary substantially from each other depending on the extent of displacement, fracture configuration, physiological age of the patient, bone quality or other relative factors. Nonoperative management is considered only when patients are seriously ill or presented with excessive surgical risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| three screws fixation | Experimental | Procedure: fixationfemoral neck fractures were fixed with three converted screws |
| four screws fixation | Experimental | Procedure: fixationfemoral neck fractures were fixed with four screws |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- closed femoral neck fracture
- no fractures at other sites
- surgical treatment with cannulated compression screws or PFNA
- follow-up time greater than 1 years.
Key exclusion criteria (3 listed)
- the absence of severe cognitive dysfunction,
- the presence of a pathological femoral neck fracture
- previous femoral neck fracture, treated with other internal fixations and surgical treatment with open reduction.
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 |
|---|---|---|
| fixationtreated with different fixation method | Procedure or surgery | four screws fixation, three screws fixation |
Primary outcome
outcome measure were evaluated by femoral neck shortening with X rays
Time frame: up to 12 months
femoral neck shortening after 1 year with radiology measure,
3 secondary outcomes
nonunion
Time frame: up to 12 months
screw-exit
Time frame: up to 12 months
cut-out
Time frame: up t 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
- Derived from this study: PubMed 30526163Guo J, Dong W, Yin B, Jin L, Lin Z, Hou Z, Zhang Y. Intramedullary nails with cannulated screw fixation for the treatment of unstable femoral neck fractures. J Int Med Res. 2019 Feb;47(2):557-568. doi: 10.1177/0300060518816185. Epub 2018 Dec 11.
- Individual participant dataSharing planned: No. the data should be allowed by Zhang Yingze
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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.
zhiyong Hou, MD study director
Hebei Medical University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fixation in people with Femoral Neck Fracture, run by Hebei Medical University Third Hospital at 1 site in China.
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 4 inclusion and 3 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 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Zhang Yingze (18533112888, dryzzhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
outcome measure were evaluated by femoral neck shortening with X rays (time frame: up to 12 months). 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 NCT03550079, which also lists 1 linked publication.
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 13 Jun 2018.