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

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.

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Key information

Conditions

Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital, Boston, Massachusetts, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Registry Creation

Time frame: 2 years

The development of a multi-center registry of all anterior cruciate ligament reconstruction performed in the pediatric population with anterior cruciate ligament tear.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

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 Research Institute
Dartmouth-Hitchcock Medical Center
Duke University
Johns Hopkins University
Le Bonheur Children's Hospital
Nemours Children's Health System
University of Texas Southwestern Medical Center
University of Texas at Austin

Registry information

Acronym: SPAIN-ACL

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Apr 1, 2020
Registry last updated: Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed