Minimizing Complications in Scoliosis Surgery in Children With Cerebral Palsy

Completed

• Conditions: Cerebral Palsy
• Interventions: Procedure: The use of two attending surgeons during posterior spinal fusion

• Registration Number: NCT02547090
• Lead Sponsor: Phoenix Children's Hospital

Brief Summary

Background:

Posterior spinal fusion (PSF) in children with cerebral palsy (CP) carries a high risk of complications and mortality. Complication rates have been reported as high as 45%, and infection rates typically reported at 15%. Efforts to improve efficiency by reducing operative time and blood loss could decrease these risks. The purpose of this study is to investigate the impact of utilizing two attending surgeons on blood loss, operative time, and complications in this population.

Methods:

This is a prospective, matched cohort analysis with a consecutive series of patients with CP who underwent PSF, with two attending surgeons, in 2012. These are matched with a control group that had a single-surgeon team (operative dates 2008-2010), assisted by a resident, PA, or RN-FA. The groups are compared using paired Student T-tests and chi square tests (significance set a p\<0.05).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2014-05
• Study Completion: 2015-03
• Status Verified: 2015-09
• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-09-10
• Last Update Submitted: 2015-09-10
• Study First Posted: 2015-09-11
• Last Update Posted: 2015-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Cerebral palsy
• neuromuscular scoliosis requiring posterior spinal fusion (>50 degree Cobb)
• PSF from 2008-2012 at Phoenix Children's Hospital
• GMFCS IV or V

Exclusion Criteria

• Diagnosis other than CP
• GMFCS I-III
• Previous spine deformity surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CP who underwent PSF by two attendings in 2012	The use of two attending surgeons during posterior spinal fusion	-

Primary Outcome Measures

Name	Time	Method
Complications due to PFS surgery	Post-operative hospital stay (up to 12 days)

Secondary Outcome Measures

Name	Time	Method
Surgical time	intraoperative
Estimated blood loss	intraoperative
Length of Stay	During hospitalization (up to 12 days)