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

NCT04329117 | Completed DMC

• 1 other identifier: P00031812
• Study Type: observational
• Target: 526
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Anterior Cruciate Ligament Injuries

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Incarcerated subjects
• Non-English speaking families and subjects

Sponsors & Collaborators

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

Study Sites (2)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston Children's Hospital

Waltham, Massachusetts, 02453, United States

Location

Related Publications (2)

• Mandler T, Li G, Sadacharam K, Staffa SJ, Chidambaran V, O'Brien E, Kastner Ungar G, Muhly WT, Cravero J, Fernandez AM; SPAIN-ACL Investigators. Regional anesthesia and functional outcomes after anterior cruciate ligament reconstruction surgery in adolescent patients: Society of Pediatric Anesthesia Improvement Network (SPAIN). Reg Anesth Pain Med. 2025 Oct 29:rapm-2025-107017. doi: 10.1136/rapm-2025-107017. Online ahead of print.

  PMID: 41167613 DERIVED

• Sadacharam K, Mandler T, Staffa SJ, Pestieau SR, Fuller C, Ellington M, Sparks JW, Fernandez AM; SPAIN-ACL Investigators. Regional Anesthesia and Pain Outcomes After Anterior Cruciate Ligament Reconstruction Surgery in Pediatric Patients: Society of Pediatric Anesthesia Improvement Network. Anesth Analg. 2026 Jan 1;142(1):93-101. doi: 10.1213/ANE.0000000000007376. Epub 2025 Jan 29.

  PMID: 39879136 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Joseph Cravero, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 1, 2020
• Study Start: December 26, 2020
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

US (2)