ACL ReconstructionNCT03929237
When do School-aged Patients Return to School After ACL Surgery?
An observational study of ACL Reconstruction, run by St. Louis University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- ACL Reconstruction
- What is being tested?
- observe when return to school after surgery
- How many people
- 58 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Apr 2019to 31 Dec 2021
- 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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: School aged patients who undergo ACL reconstruction surgery during the school year
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Saint Louis University
St Louis, Missouri, 63110
SSM Health Saint Louis University Hospital
St Louis, Missouri, 63110
About this study
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.
Read the 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).
- Conditions
- ACL Reconstruction
- Being tested
- observe when return to school after surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
When return to school after surgery
days from surgery to return to school
Measured: 1-2 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start18 Apr 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL ReconstructionStudies of the same condition, open and under way.
- 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, University of Pittsburgh
- Responsible party
- Principal investigator, Scott Kaar, MD, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929237
- Sponsor's protocol ID
- 29979
- Status last verified
- Feb 2022
- First submitted
- 22 Apr 2019
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- When do School-aged Patients Return to School After ACL Surgery?
- ClinicalTrials.gov ID
- NCT03929237
- Acronym / sponsor ID
- 29979
- Conditions
- ACL Reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Collaborators
- University of Michigan, University of Pittsburgh
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 26 Apr 2019 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- School aged patients who undergo ACL reconstruction surgery during the school year
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observe when return to school after surgeryShort written questionnaire asking when they returned to school and what accommodations, if any, the school made available for them | Other | – |
Primary outcome
When return to school after surgery
Time frame: 1-2 weeks post-operatively
days from surgery to return to school
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 7 Feb 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ACL Reconstruction, run by St. Louis University 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 4 inclusion and 3 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 7 Feb 2022. 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?
When return to school after surgery (time frame: 1-2 weeks post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2022.