Minimizing Complications in Scoliosis Surgery in Children With Cerebral Palsy

Sponsor

Phoenix Children's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02547090

Collaborator

(none)

Enrollment

36.9

Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy	Procedure: The use of two attending surgeons during posterior spinal fusion

Study Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
CP who underwent PSF by two attendings in 2012	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.
CP who underwent PSF by a single surgeon from 2008-2010

Arm

Intervention/Treatment

CP who underwent PSF by two attendings in 2012

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.

CP who underwent PSF by a single surgeon from 2008-2010

Outcome Measures

Primary Outcome Measures

Complications due to PFS surgery [Post-operative hospital stay (up to 12 days)]

Secondary Outcome Measures

Surgical time [intraoperative]
Estimated blood loss [intraoperative]
Length of Stay [During hospitalization (up to 12 days)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Phoenix Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Phoenix Children's Hospital

ClinicalTrials.gov Identifier:

NCT02547090

Other Study ID Numbers:

11-124

First Posted:

Sep 11, 2015

Last Update Posted:

Sep 11, 2015

Last Verified:

Sep 1, 2015

Additional relevant MeSH terms:

Cerebral Palsy

Study Results

No Results Posted as of Sep 11, 2015