Fixation for the Treatment of Femoral Neck Fractures
Primary Purpose
Femoral Neck Fracture
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
fixation
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neck Fracture
Eligibility Criteria
Inclusion Criteria:
- closed femoral neck fracture
- no fractures at other sites
- surgical treatment with cannulated compression screws or PFNA
- follow-up time greater than 1 years.
Exclusion Criteria:
- 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.
Sites / Locations
- the Third Hospital of Hebei Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
three screws fixation
four screws fixation
Arm Description
femoral neck fractures were fixed with three converted screws
femoral neck fractures were fixed with four screws
Outcomes
Primary Outcome Measures
outcome measure were evaluated by femoral neck shortening with X rays
femoral neck shortening after 1 year with radiology measure,
Secondary Outcome Measures
nonunion
the number of nonunion at the end of follow up in patients
screw-exit
screw-exit afer 1 year with X rays in all patients
cut-out
cut-out of the screw evaluating with x rays in all patients
Full Information
NCT ID
NCT03550079
First Posted
April 23, 2018
Last Updated
June 11, 2018
Sponsor
Hebei Medical University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03550079
Brief Title
Fixation for the Treatment of Femoral Neck Fractures
Official Title
the Fixation Method for the Treatment of Femoral Neck Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Anticipated)
Study Completion Date
December 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Medical University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 . 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
three screws fixation
Arm Type
Experimental
Arm Description
femoral neck fractures were fixed with three converted screws
Arm Title
four screws fixation
Arm Type
Experimental
Arm Description
femoral neck fractures were fixed with four screws
Intervention Type
Procedure
Intervention Name(s)
fixation
Intervention Description
treated with different fixation method
Primary Outcome Measure Information:
Title
outcome measure were evaluated by femoral neck shortening with X rays
Description
femoral neck shortening after 1 year with radiology measure,
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
nonunion
Description
the number of nonunion at the end of follow up in patients
Time Frame
up to 12 months
Title
screw-exit
Description
screw-exit afer 1 year with X rays in all patients
Time Frame
up to 12 months
Title
cut-out
Description
cut-out of the screw evaluating with x rays in all patients
Time Frame
up t 12 months
Other Pre-specified Outcome Measures:
Title
operative time in every patient
Description
outcome measure were evaluated by operative time
Time Frame
intraoperation
Title
fluoroscopy time intraoperatively
Description
outcome measure were evaluated by operative time and fluroscopy time
Time Frame
intraoperation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
closed femoral neck fracture
no fractures at other sites
surgical treatment with cannulated compression screws or PFNA
follow-up time greater than 1 years.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang Yingze
Phone
18533112888
Email
dryzzhang@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hou Zhiyong
Phone
18533112800
Email
drzyhou@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhiyong Hou, MD
Organizational Affiliation
Hebei Medical University Third Hospital
Official's Role
Study Director
Facility Information:
Facility Name
the Third Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Wei
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
the data should be allowed by Zhang Yingze
Citations:
PubMed Identifier
30526163
Citation
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.
Results Reference
derived
Learn more about this trial
Fixation for the Treatment of Femoral Neck Fractures
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