Recruiting

ACL Score

Sponsor:

Andrews Research & Education Foundation

Code:

NCT05578248

Conditions

ACL Injury

Eligibility Criteria

Sex: All

Age: 14 - 24

Healthy Volunteers: Not accepted

Interventions

Magnetic Resonance Imaging (MRI)

ACL reconstruction

Study Details

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.

Conditions

ACL Injury

Study ID

NCT05578248

Start date

Feb 3, 2022

Status verified date

Oct, 2022

Completion date

Jun, 2023

Anticipated

Primary completion date

Jun, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 24

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Collegiate Athletes

Group designated for collegiate athletes; see protocol for treatment plan

Pre-collegiate Athletes

Group designated for pre-collegiate, or high school-age, athletes; see protocol for treatment plan

Interventions

Magnetic Resonance Imaging (MRI)

Non-invasive imaging technology that produces three-dimensional detailed anatomical images

ACL reconstruction

Surgical procedure to repair damaged or severed anterior cruciate ligament in the knee

Primary outcome measure

  • Tampa Scale for Kinesiophobia [ Time Frame: Through study completion, an average of 1 year ]
  • Sports Participation Assessment [ Time Frame: Through study completion, an average of 1 year ]
  • Reinjury Assessment [ Time Frame: Through study completion, an average of 1 year ]
  • International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) [ Time Frame: Every month, up to 1 year; assessing for change ]
  • Patient Reported Outcomes Measurement Information Systems (PROMIS) [ Time Frame: Every month, up to 1 year; assessing for change ]
  • Single Assessment Numeric Evaluation (SANE) [ Time Frame: Every month, up to 1 year; assessing for change ]

Central Contacts and Locations

Central contacts

Jessi Truett, MA, BCBA

(850) 916-8570jessica.truett@andrewsref.org

Chandler Bridges, MS

(850) 916-8584chandler.bridges@andrewsref.org

Locations

Andrews Research and Education Foundation

Recruiting

Gulf Breeze, Florida, United States, 32561

Contacts

Jessi Truett, MA, BCBA

850-916-8570jessica.truett@andrewsref.org

Chandler Bridges, MS

8509168584chandler.bridges@andrewsref.org

More Information

Sponsor

Andrews Research & Education Foundation

Last update posted

Oct 13, 2022

Last verified

Oct, 2022

Keywords

  • Cohort
  • return to sport

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Andrews Research & Education Foundation on 2022-10-13.