Minimizing Complications in Scoliosis Surgery in Children With Cerebral Palsy

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).

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

The use of two attending surgeons during posterior spinal fusion

Procedure

Patients in the experimental group received posterior spinal fusion with two attending surgeons. Patients in the control group received posterior spinal fusion with one attending surgeon and one first assist, which could be a resident, PA, or nurse.

Primary outcomes

Complications due to PFS surgery

Time frame: Post-operative hospital stay (up to 12 days)

Secondary outcomes

Surgical time

Time frame: intraoperative
Estimated blood loss

Time frame: intraoperative
Length of Stay

Time frame: During hospitalization (up to 12 days)

Sponsors and collaborators

Lead sponsor

Phoenix Children's Hospital

Other

Registry information

Official study title

The Effect of Two Surgeons on Blood Loss and Operative Time in Cerebral Palsy (CP) Patients Undergoing Posterior Spinal Fusion

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2015
First posted: Sep 11, 2015
Registry last updated: Sep 11, 2015

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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