NCT03929237

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 7, 2022

Status Verified

February 1, 2022

Enrollment Period

2.7 years

First QC Date

April 22, 2019

Last Update Submit

February 3, 2022

Conditions

ACL Reconstruction

Outcome Measures

Primary Outcomes (1)

  • When return to school after surgery

    days from surgery to return to school

    1-2 weeks post-operatively

Interventions

observe when return to school after surgeryOTHER

Short written questionnaire asking when they returned to school and what accommodations, if any, the school made available for them

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

School aged patients who undergo ACL reconstruction surgery during the school year

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Saint Louis University

St Louis, Missouri, 63110, United States

Location

SSM Health Saint Louis University Hospital

St Louis, Missouri, 63110, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 22, 2019

First Posted

April 26, 2019

Study Start

April 18, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 7, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)