NCT02803983

Brief Summary

The purpose of this study is to compare the early postoperative radiologic and clinical outcomes of pediatric hip plate and cannulated screw fixation in pediatric femoral neck fracture (Delbet type II and Delbet type III).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
Last Updated

February 22, 2018

Status Verified

June 1, 2016

Enrollment Period

Same day

First QC Date

June 2, 2016

Last Update Submit

February 21, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Radiographic union

    The time of radiographic union.

    Through study completion, an average of 0.5 year.

Secondary Outcomes (1)

  • The Ratliff classification standard score

    Through study completion, an average of 1 year.

Other Outcomes (1)

  • The complication

    Through study completion, an average of 1 year.

Study Arms (2)

Pediatric hip plate

The children were treated with pediatric hip plate.

Procedure: Pediatric hip plate

Cannulated screw

The children were treated with cannulated screw.

Procedure: Cannulated screw

Interventions

Children were treated with pediatric hip plate.

Pediatric hip plate

Children were treated with cannulated screw.

Cannulated screw

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

pediatric femoral neck fracture(Delbet type II and Delbet type III)

You may qualify if:

  • Patients with fractures that met these criteria, underwent definitive surgery and had complete clinical and radiographic follow up until fracture union at either institution were included in this study.

You may not qualify if:

  • Pathologic fractures, and fractures in patients with osteogenesis imperfecta, neuromuscular disorders or any systemic disease that was associated with a predisposition to fractures or altered fracture healing were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • RATLIFF AH. Fractures of the neck of the femur in children. J Bone Joint Surg Br. 1962 Aug;44-B:528-42. doi: 10.1302/0301-620X.44B3.528. No abstract available.

  • Joeris A, Audige L, Ziebarth K, Slongo T. The Locking Compression Paediatric Hip Plate: technical guide and critical analysis. Int Orthop. 2012 Nov;36(11):2299-306. doi: 10.1007/s00264-012-1643-1. Epub 2012 Aug 26.

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director,Orthopaedics

Study Record Dates

First Submitted

June 2, 2016

First Posted

June 17, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

February 22, 2018

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share