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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03550079
Other study ID # 11156458
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date December 30, 2018

Study information

Verified date June 2018
Source Hebei Medical University Third Hospital
Contact Zhang Yingze
Phone 18533112888
Email dryzzhang@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 . 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 .


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 30, 2018
Est. primary completion date December 30, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Intervention

Procedure:
fixation
treated with different fixation method

Locations

Country Name City State
China the Third Hospital of Hebei Medical University Shijiazhuang Hebei

Sponsors (1)

Lead Sponsor Collaborator
Hebei Medical University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other operative time in every patient outcome measure were evaluated by operative time intraoperation
Other fluoroscopy time intraoperatively outcome measure were evaluated by operative time and fluroscopy time intraoperation
Primary outcome measure were evaluated by femoral neck shortening with X rays femoral neck shortening after 1 year with radiology measure, up to 12 months
Secondary nonunion the number of nonunion at the end of follow up in patients up to 12 months
Secondary screw-exit screw-exit afer 1 year with X rays in all patients up to 12 months
Secondary cut-out cut-out of the screw evaluating with x rays in all patients up t 12 months
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