Fixation for the Treatment of Femoral Neck Fractures

NCT03550079 | Unknown

• 1 other identifier: 11156458
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 .

Conditions

Femoral Neck Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• nonunion

  up to 12 months

• screw-exit

  up to 12 months

• cut-out

  up t 12 months

Other Outcomes (2)

• operative time in every patient

  intraoperation

• fluoroscopy time intraoperatively

  intraoperation

Study Arms (2)

three screws fixation

EXPERIMENTAL

femoral neck fractures were fixed with three converted screws

Procedure: fixation

four screws fixation

EXPERIMENTAL

femoral neck fractures were fixed with four screws

Procedure: fixation

Interventions

fixation PROCEDURE

treated with different fixation method

four screws fixation; three screws fixation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• closed femoral neck fracture
• no fractures at other sites
• surgical treatment with cannulated compression screws or PFNA
• follow-up time greater than 1 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebei Medical University Third Hospital: lead

Study Sites (1)

the Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 30526163 DERIVED

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• zhiyong Hou, MD

  Hebei Medical University Third Hospital

  STUDY DIRECTOR

Central Study Contacts

Zhang Yingze

CONTACT

18533112888; dryzzhang@126.com

Hou Zhiyong

CONTACT

18533112800; drzyhou@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: June 8, 2018
• Study Start: October 1, 2017
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: June 13, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)