Minimizing Complications in Scoliosis Surgery in Children With Cerebral Palsy
NCT ID: NCT02547090
Last Updated: 2015-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2012-02-29
2015-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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CP who underwent PSF by two attendings in 2012
The use of two attending surgeons during posterior spinal fusion
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.
CP who underwent PSF by a single surgeon from 2008-2010
No interventions assigned to this group
Interventions
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The use of two attending surgeons during posterior spinal fusion
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.
Eligibility Criteria
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Inclusion Criteria
* neuromuscular scoliosis requiring posterior spinal fusion (\>50 degree Cobb)
* PSF from 2008-2012 at Phoenix Children's Hospital
* GMFCS IV or V
Exclusion Criteria
* GMFCS I-III
* Previous spine deformity surgery
18 Years
ALL
No
Sponsors
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Phoenix Children's Hospital
OTHER
Responsible Party
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Other Identifiers
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11-124
Identifier Type: -
Identifier Source: org_study_id
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