Fixation for the Treatment of Femoral Neck Fractures

Femoral Neck Fracture Clinical Trial

Official title:

the Fixation Method for the Treatment of Femoral Neck Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03550079
• Other study ID #: 11156458
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Femoral Neck Fracture
• Femoral Neck Fractures
• Fractures, Bone

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