Clinical trial NCT03550079: Fixation for the Treatment of Femoral Neck Fractures
Official title: the Fixation Method for the Treatment of Femoral Neck Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Femoral Neck Fracture
Lead sponsor: Hebei Medical University Third Hospital
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: outcome measure were evaluated by femoral neck shortening with X rays
timeFrame: up to 12 months
Secondary outcomes:
measure: nonunion
timeFrame: up to 12 months
measure: screw-exit
timeFrame: up to 12 months
measure: cut-out
timeFrame: up t 12 months
Other outcomes:
measure: operative time in every patient
timeFrame: intraoperation
measure: fluoroscopy time intraoperatively
timeFrame: intraoperation
Locations:
city: Shijiazhuang
country: China
facility: the Third Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: Hebei Medical University Third Hospital
name: zhiyong Hou, MD
role: STUDY_DIRECTOR
References:
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.