Fixation for the Treatment of Femoral Neck Fractures

the Fixation Method for the Treatment of Femoral Neck Fractures

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 .

Study Overview

• Status: Unknown
• Conditions: Femoral Neck Fracture
• Intervention / Treatment: Procedure: fixation

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Recruiting
      • The Third Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: three screws fixation; femoral neck fractures were fixed with three converted screws	Procedure: fixation; treated with different fixation method
Experimental: four screws fixation; femoral neck fractures were fixed with four screws	Procedure: fixation; treated with different fixation method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time in every patient	outcome measure were evaluated by operative time	intraoperation
fluoroscopy time intraoperatively	outcome measure were evaluated by operative time and fluroscopy time	intraoperation

Collaborators and Investigators

• Sponsor: Hebei Medical University Third Hospital
• Investigators: Study Director: zhiyong Hou, MD, Hebei Medical University Third Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): December 30, 2018
• Study Completion (Anticipated): December 30, 2018

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: May 25, 2018
• First Posted (Actual): June 8, 2018

Study Record Updates

• Last Update Posted (Actual): June 13, 2018
• Last Update Submitted That Met QC Criteria: June 11, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Fractures, Bone; Femoral Neck Fractures
• Other Study ID Numbers: 11156458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: the data should be allowed by Zhang Yingze

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No