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Andrews Return to Sport ACL Score

A

Andrews Research & Education Foundation

Status

Enrolling

Conditions

ACL Injury

Treatments

Diagnostic Test: Magnetic Resonance Imaging (MRI)
Procedure: ACL reconstruction

Study type

Observational

Funder types

Other

Identifiers

NCT05578248
Return to Sport

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

14 to 24 years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Collegiate Athletes
Description:
Group designated for collegiate athletes; see protocol for treatment plan
Treatment:
Diagnostic Test: Magnetic Resonance Imaging (MRI)
Procedure: ACL reconstruction
Pre-collegiate Athletes
Description:
Group designated for pre-collegiate, or high school-age, athletes; see protocol for treatment plan
Treatment:
Diagnostic Test: Magnetic Resonance Imaging (MRI)
Procedure: ACL reconstruction

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Jessi Truett, MA, BCBA; Chandler Bridges, MS

Data sourced from clinicaltrials.gov

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