Minimizing Complications in Scoliosis Surgery in Children With Cerebral Palsy

NCT02547090 | Completed

• 1 other identifier: 11-124
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Complications due to PFS surgery

  Post-operative hospital stay (up to 12 days)

Secondary Outcomes (3)

• Surgical time

  intraoperative

• Estimated blood loss

  intraoperative

• Length of Stay

  During hospitalization (up to 12 days)

Study Arms (2)

CP who underwent PSF by two attendings in 2012

Procedure: The use of two attending surgeons during posterior spinal fusion

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

Interventions

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.

CP who underwent PSF by two attendings in 2012

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Cerebral palsy
• neuromuscular scoliosis requiring posterior spinal fusion (\>50 degree Cobb)
• PSF from 2008-2012 at Phoenix Children's Hospital
• GMFCS IV or V

You may not qualify if:

• Diagnosis other than CP
• GMFCS I-III
• Previous spine deformity surgery

Sponsors & Collaborators

• Phoenix Children's Hospital: lead

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 11, 2015
• Study Start: February 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: March 1, 2015
• Last Updated: September 11, 2015

Record last verified: 2015-09