Society for Pediatric Anesthesia Improvement Network- Anterior Cruciate Ligament Reconstruction Outcomes Project

Anterior Cruciate Ligament Injuries Clinical Trial

— SPAIN-ACL  

Official title:

Society for Pediatric Anesthesia Improvement Network- Anterior Cruciate Ligament Reconstruction Outcomes Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04329117
• Other study ID #: P00031812
• Status: Completed
• Start date: December 26, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: February 2023
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 526
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Boston Children's Hospital	Waltham	Massachusetts

Sponsors (14)

Lead Sponsor

Collaborator

Boston Children's Hospital

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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