Clinical trial NCT05578248: Andrews Return to Sport ACL Score
Official title: The Andrews Return to Sport ACL Score: A Developmental Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ACL Injury
Keywords: Cohort
return to sport
Lead sponsor: Andrews Research & Education Foundation
Sponsor class: OTHER
Collaborators: name: Florida
First posted: 2022-10-13
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 competitive pre-collegiate or collegiate athletes who have recently suffered from an ACL injury that requires reconstructive surgery

Brief summary: This project will develop a data-driven decision making model to assess a competitive athlete's readiness to return to sport after ACL injury and surgery safely.

Detailed description: One hundred pre-collegiate or collegiate athlete participants will be recruited for this study. The duration of the treatment plan will be 24 months. Each of the participants will be qualified for the study due to falling within all inclusion criterion and no exclusion criterion. The screening of the inclusion criterion will occur at visit one of the study. At this time, the AREF Research Team will review and collect informed consent from each participant. Visit two will occur three (3) months after each participant's ACL reconstruction surgery. At this time, an evaluation by the treating physician will occur along with functional movement assessment and MRI. Visit three will occur six (6) months after each participant's ACL reconstruction surgery. At this time, an evaluation by the treating physician will occur along with functional movement assessment and MRI. Visit four will occur nine (9) months after each participant's ACL reconstruction surgery. At this time, an medical evaluation by the treating leading physician will occur along with functional movement assessment and MRI. Visit five will occur twelve (12) months after each participant's ACL reconstruction surgery. At this time, an evaluation by the treating physician will occur along with functional movement assessment and MRI. Visit six will occur eighteen (18) months after each participant's ACL reconstruction surgery. At this time, an evaluation by the treating physician will occur along with functional movement assessment and MRI. Visit seven will occur twenty-four (24) months after each participant's ACL reconstruction surgery. At this time, an evaluation by the treating physician will occur along with functional movement assessment and MRI. At each time point, the treating physician or the therapist performing the functional movement assessment can choose to limit the functional movement assessment if there are concerns that the patient may not be ready for the expected load of one or more elements of the functional movement assessment.

At each monthly time point after ACL reconstruction, patient reported outcomes will be collected by the research team to assist in assessing the overall health and confidence in return to sport for each athlete. The following patient reported outcomes will be collected in written or electronic format after informed consent has been obtained from each participant: Sports Participation, Reinjury, Tampa Kinesiophobia Scale, IKDC, PROMIS, SANE.

Eligibility criteria: Inclusion Criteria:

* Age 14-24 years
* Require ACL reconstruction surgery
* No other ligament injury which would require repair or reconstruction to lower extremity is present as assessed by treating physician
* Exhibits desire to return to pre-injury competitive level
* Assessed to be in good physical health condition by the treating physician

Exclusion Criteria:

* Requires more than one ACL reconstruction surgery at time of screening
* Has comorbid lower extremity diagnoses which would impede return to sport as assessed by the treating physician
* Does not desire to return to pre-injury competitive sport level

Primary outcomes:
measure: Tampa Scale for Kinesiophobia
timeFrame: Through study completion, an average of 1 year
measure: Sports Participation Assessment
timeFrame: Through study completion, an average of 1 year
measure: Reinjury Assessment
timeFrame: Through study completion, an average of 1 year
measure: International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)
timeFrame: Every month, up to 1 year; assessing for change
measure: Patient Reported Outcomes Measurement Information Systems (PROMIS)
timeFrame: Every month, up to 1 year; assessing for change
measure: Single Assessment Numeric Evaluation (SANE)
timeFrame: Every month, up to 1 year; assessing for change
Secondary outcomes:
Other outcomes:
Locations:
city: Gulf Breeze
country: United States
facility: Andrews Research and Education Foundation
state: Florida
Study officials:
affiliation: Orthopedic Surgeon
name: Adam Anz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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