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Completed

NCT Number: NCT02803983

Pediatric Hip Plate Versus Cannulated Screw in Pediatric Femoral Neck Fracture

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).

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Key information

Conditions

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

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pediatric hip plate

Procedure

Children were treated with pediatric hip plate.

Cannulated screw

Procedure

Children were treated with cannulated screw.

Primary outcomes

  1. Radiographic union

    Time frame: Through study completion, an average of 0.5 year.

    The time of radiographic union.

Secondary outcomes

  1. The Ratliff classification standard score

    Time frame: Through study completion, an average of 1 year.

    Ratliff classification standard score was administered to determine the pain, function, activity and radiographic change.

Other outcomes

  1. The complication

    Time frame: Through study completion, an average of 1 year.

    The complication was evaluated by osteonecrosis, epiphyseal arrest, premature physeal closure, limb length discrepancy (over 3 cm) and internal fixation failure.

Sponsors and collaborators

Lead sponsor

The Fuzhou No 2 Hospital

Other

Registry information

Official study title

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

Acronym: PFNF

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 17, 2016
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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