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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03929237
Other study ID # 29979
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 18, 2019
Est. completion date December 31, 2021

Study information

Verified date February 2022
Source St. Louis University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 14 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
observe when return to school after surgery
Short written questionnaire asking when they returned to school and what accommodations, if any, the school made available for them

Locations

Country Name City State
United States Saint Louis University Saint Louis Missouri
United States SSM Health Saint Louis University Hospital Saint Louis Missouri

Sponsors (3)

Lead Sponsor Collaborator
St. Louis University University of Michigan, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary When return to school after surgery days from surgery to return to school 1-2 weeks post-operatively
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