An observational study in Cerebral Palsy, sponsored by Phoenix Children's Hospital. Completed. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2015-09-11.
Sponsored by Phoenix Children's Hospital · Observational
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).
1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.
This study's enrollment of 50 is below the median of 63 across 455 observational studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Phoenix Children's Hospital is the lead sponsor of 40 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study group consisted of 25 consecutive patients with CP and progressive neuromuscular scoliosis who underwent PSF in 2012 with the use of a two surgeon team. The control group consisted of a consecutive series of patients with CP who underwent PSF by a single surgeon from 2008-2010 at the same institution. The control group was a cohort of patients matched for age, gender, weight and Cobb angle.
Exclusion Criteria:
Procedure: 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.
Complications due to PFS surgery
Time frame: Post-operative hospital stay (up to 12 days)
Surgical time
Time frame: intraoperative
Estimated blood loss
Time frame: intraoperative
Length of Stay
Time frame: During hospitalization (up to 12 days)
No study locations are listed for this record.
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Phoenix Children's Hospital