Fixation for the Treatment of Femoral Neck Fractures

Not Applicable

• Conditions: Femoral Neck Fracture
• Interventions: Procedure: fixation

• Registration Number: NCT03550079
• Lead Sponsor: Hebei Medical University Third Hospital

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.

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2018-04-23
• Study First Submitted QC: 2018-05-25
• Status Verified: 2018-06
• Study First Posted: 2018-06-08
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-13
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
four screws fixation	fixation	femoral neck fractures were fixed with four screws
three screws fixation	fixation	femoral neck fractures were fixed with three converted screws

Primary Outcome Measures

Name	Time	Method
outcome measure were evaluated by femoral neck shortening with X rays	up to 12 months	femoral neck shortening after 1 year with radiology measure,

Secondary Outcome Measures

Name	Time	Method
cut-out	up t 12 months	cut-out of the screw evaluating with x rays in all patients
nonunion	up to 12 months	the number of nonunion at the end of follow up in patients
screw-exit	up to 12 months	screw-exit afer 1 year with X rays in all patients

Trial Locations

Locations (1)

the Third Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China