Anterior Cruciate Ligament InjuriesSPAIN-ACLNCT04329117
Society for Pediatric Anesthesia Improvement Network- Anterior Cruciate Ligament Reconstruction Outcomes Project
An observational study of Anterior Cruciate Ligament Injuries, run by Boston Children's Hospital at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- How many people
- 526 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Dec 2020to 31 Jan 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Incarcerated subjects
- Non-English speaking families and subjects
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
Boston Children's Hospital
Waltham, Massachusetts, 02453
About this study
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injuries
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start26 Dec 2020
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 526 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth-Hitchcock Medical Center, Johns Hopkins University, Children's Hospital Medical Center, Cincinnati, Children's Hospital Los Angeles, University of Texas Southwestern Medical Center, Duke University, Alfred I. duPont Hospital for Children, Akron Children's Hospital, Children's National Research Institute, Le Bonheur Children's Hospital, Children's Hospital Colorado, Nemours Children's Health System, University of Texas at Austin
- Responsible party
- Principal investigator, Joseph Cravero, Boston Children's Hospital
- Investigators
- Joseph Cravero, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329117
- Sponsor's protocol ID
- P00031812
- Acronym
- SPAIN-ACL
- Status last verified
- Feb 2023
- First submitted
- 30 Mar 2020
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41167613Sadacharam 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.
PubMed 39879136
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Society for Pediatric Anesthesia Improvement Network- Anterior Cruciate Ligament Reconstruction Outcomes Project
- ClinicalTrials.gov ID
- NCT04329117
- Acronym / sponsor ID
- SPAIN-ACL / P00031812
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 526 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Dartmouth-Hitchcock Medical Center, Johns Hopkins University, Children's Hospital Medical Center, Cincinnati, Children's Hospital Los Angeles, University of Texas Southwestern Medical Center, Duke University, Alfred I. duPont Hospital for Children, Akron Children's Hospital, Children's National Research Institute, Le Bonheur Children's Hospital, Children's Hospital Colorado, Nemours Children's Health System, University of Texas at Austin
- Study start
- 26 Dec 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Incarcerated subjects
- Non-English speaking families and subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Derived from this study: PubMed 41167613Mandler 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.
- Derived from this study: PubMed 39879136Sadacharam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Cravero, MD principal investigator
Boston Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injuries, run by Boston Children's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Registry Creation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04329117, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.