Minimizing Complications in Scoliosis Surgery in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547090
• Other study ID #: 11-124
• Status: Completed
• Phase: N/A
• First received: September 9, 2015
• Last updated: September 10, 2015
• Start date: February 2012
• Est. completion date: March 2015

Study information

• Verified date: September 2015
• Source: Phoenix Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Phoenix Children's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications due to PFS surgery		Post-operative hospital stay (up to 12 days)	Yes
Secondary	Surgical time		intraoperative	Yes
Secondary	Estimated blood loss		intraoperative	Yes
Secondary	Length of Stay		During hospitalization (up to 12 days)	Yes