Society for Pediatric Anesthesia Improvement Network- Anterior Cruciate Ligament Reconstruction Outcomes Project (SPAIN-ACL)

The primary objective is to create a multicenter registry which captures information relating to the perioperative anesthesia course and management of children undergoing anterior cruciate ligament reconstruction and to examine practice patterns and incidence of complications. Data from any single institution involved in this registry will be used for local safety and quality improvement efforts. In addition data from each institution can be compared to the information from the entire group of institutions participating in the project, thus providing a measure for comparison with national practice. The aggregate multi-institutional data set will be used to develop quality benchmarks for national safety and quality improvement efforts and best practice recommendation. We believe that this registry can also demonstrate how web based data collection can be used to evaluate clinical anesthesia outcomes for surgeries with a low incidence of critical events but with significant variability in medical management.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Injuries

Detailed Description

This multi institutional registry will capture data relating to perioperative practices and complications, some of which may be relatively infrequent. The goal of this group is to create this registry to be used for local safety and quality improvement and multi-center benchmarking in this population. Reports generated from the registry will provide individual institutions with comparative data showing how their site performs compared to composite averages from all participating sites. Queries of the composite data set may allow for identification of factors associated with improved outcomes in this population. Future queries of the data-base for research purposes will require approval of the participating members of SPAIN.

• Study Type: Observational
• Enrollment (Actual): 526

Contacts and Locations

• Study Contact: Name: Joseph Cravero, MD; Phone Number: 56457 617-355-6457; Email: joseph.cravero@childrens.harvard.edu
• Study Contact Backup: Name: Jocelyn M Booth, BSN; Phone Number: 41696 617-919-1696; Email: jocelyn.booth@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
    • Waltham, Massachusetts, United States, 02453
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All children undergoing scheduled surgical procedures on the anterior cruciate ligament in a hospital setting or surgical day center, aged 12-18 years old.

Description

Inclusion Criteria:

• Males and females ages 12 years to 17.5 years
• Patients undergoing scheduled surgical procedures on the anterior cruciate ligament construction surgery in a hospital setting or surgical day center.

Exclusion Criteria:

• Incarcerated subjects
• Non-English speaking families and subjects

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Registry Creation	The development of a multi-center registry of all anterior cruciate ligament reconstruction performed in the pediatric population with anterior cruciate ligament tear.	2 years

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Johns Hopkins University; Children's Hospital Colorado; Duke University; Dartmouth-Hitchcock Medical Center; University of Texas Southwestern Medical Center; Children's Hospital Medical Center, Cincinnati; Children's Hospital Los Angeles; University of Texas at Austin; Akron Children's Hospital; Alfred I. duPont Hospital for Children; Le Bonheur Children's Hospital; Children's National Health System; Nemours Children's Health System

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 26, 2020
• Primary Completion (ACTUAL): January 31, 2022
• Study Completion (ACTUAL): January 31, 2022

Study Registration Dates

• First Submitted: March 30, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (ACTUAL): April 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: P00031812

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No