Fixation for the Treatment of Femoral Neck Fractures | NCT03550079

Studies
Fixation for the Treatment of Femoral Neck Fractures

NCT03550079

Sponsor

Hebei Medical University Third Hospital

Status

Unknown status

Last Update Posted

Jun 13, 2018Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Femoral Neck Fracture

Interventions

fixation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2017Actual

Primary Completion Date

Dec 30, 2018Estimated

Completion Date

Dec 30, 2018Estimated

First Submitted Date

Apr 23, 2018

First Submission Date that Met QC Criteria

May 25, 2018

First Posted Date

Jun 8, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2018

Last Update Posted Date

Jun 13, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
fixation	Procedure	treated with different fixation method	four screws fixation three screws fixation

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhang Yingze	Contact	18533112888		dryzzhang@126.com
Hou Zhiyong	Contact	18533112800		drzyhou@gmail.com

Overall Officials

Name	Affiliation	Role
zhiyong Hou, MD	Hebei Medical University Third Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the Third Hospital of Hebei Medical University	Recruiting	Shijiazhuang	Hebei	050000	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30526163	Derived	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.

ID	Term
D006620	Hip Fractures
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries