NCT05578248

Andrews Return to Sport ACL Score

The Andrews Return to Sport ACL Score: A Developmental Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Andrews Research & Education Foundation · Academic / Other
• Sex: All
• Age: 14 Years – 24 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ACL Injury

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Magnetic Resonance Imaging (MRI)	Non-invasive imaging technology that produces three-dimensional detailed anatomical images
PROCEDURE	ACL reconstruction	Surgical procedure to repair damaged or severed anterior cruciate ligament in the knee

Timeline

• Start date: 2022-02-03
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2022-10-13
• Last updated: 2022-10-13

Locations

1 site across 1 country: United States