Pediatric Hip Plate Versus Cannulated Screw in Pediatric Femoral Neck Fracture

Femoral Neck Fractures Clinical Trial

— PFNF  

Official title:

An Multicenter Prospective Observational Study to Pediatric Hip Plate Versus Cannulated Screw in Pediatric Femoral Neck Fracture (Delbet Type II and III)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803983
• Other study ID #: SChen
• Status: Completed
• Phase: N/A
• First received: June 2, 2016
• Last updated: February 21, 2018
• Start date: June 2016
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: The Fuzhou No 2 Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

The children aged 3 to 14 years with femoral neck fracture that were treated with pediatric hip plate and cannulated screw fixation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 14 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone

Intervention

Procedure:
• Pediatric hip plate
Children were treated with pediatric hip plate.
• Cannulated screw
Children were treated with cannulated screw.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Fuzhou No 2 Hospital

References & Publications (2)

Joeris A, Audigé 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. — View Citation

RATLIFF AH. Fractures of the neck of the femur in children. J Bone Joint Surg Br. 1962 Aug;44-B:528-42. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The complication	The complication was evaluated by osteonecrosis, epiphyseal arrest, premature physeal closure, limb length discrepancy (over 3 cm) and internal fixation failure.	Through study completion, an average of 1 year.
Primary	Radiographic union	The time of radiographic union.	Through study completion, an average of 0.5 year.
Secondary	The Ratliff classification standard score	Ratliff classification standard score was administered to determine the pain, function, activity and radiographic change.	Through study completion, an average of 1 year.