- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03929237
When do School-aged Patients Return to School After ACL Surgery?
February 3, 2022 updated by: Scott Kaar, MD, St. Louis University
We intend to survey school aged patients following ACL surgery on when they return to school.
We will analyze independent variables to determine if any relationship exists that may influence the amount of time missed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
All patients undergoing ACL surgery who are enrolled in middle or high school will be recruited for study participation.
Patients undergoing concomitant additional ligament surgery will be excluded.
The only procedure will be to answer a short written questionnaire asking when they returned to school and what accommodations, if any, the school made available for them.
This will occur at the patient's 2 week post-operative clinic visit.
This clinic visit is a standard of care visit.
Independent variables will be collected from the medical record and are all standard of care information routinely collected from this patient populations (age, sex, race, date of surgery, surgeon, sport played, grade, ACL surgery graft type, associated meniscal or chondral surgery, length of post-operative narcotic use, regional nerve block at the time of surgery, SANE score, IKDC score, brace used).
Study Type
Observational
Enrollment (Actual)
58
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Saint Louis University
-
Saint Louis, Missouri, United States, 63110
- SSM Health Saint Louis University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
School aged patients who undergo ACL reconstruction surgery during the school year
Description
Inclusion Criteria:
- ACL reconstruction surgery
- currently enrolled in middle or high school (grades 6-12)
- Surgery occurs during the school year
- No concomitant additional ligament surgery (ie. PCL, MCL, LCL or MPFL)
Exclusion Criteria:
- patient is home schooled or in non-traditional school setting (ie. school for special needs)
- concomitant additional ligament surgery
- surgery occurs outside of the school year or on a scheduled break from school
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
When return to school after surgery
Time Frame: 1-2 weeks post-operatively
|
days from surgery to return to school
|
1-2 weeks post-operatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 18, 2019
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
April 22, 2019
First Submitted That Met QC Criteria
April 25, 2019
First Posted (Actual)
April 26, 2019
Study Record Updates
Last Update Posted (Actual)
February 7, 2022
Last Update Submitted That Met QC Criteria
February 3, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 29979
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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