Andrews Return to Sport ACL Score

October 10, 2022 updated by: Andrews Research & Education Foundation

The Andrews Return to Sport ACL Score: A Developmental Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Collegiate Athletes
Group designated for collegiate athletes; see protocol for treatment plan
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
Pre-collegiate Athletes
Group designated for pre-collegiate, or high school-age, athletes; see protocol for treatment plan
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tampa Scale for Kinesiophobia
Time Frame: Through study completion, an average of 1 year
Measurement to determine the physical and pyschological effects on the rehabilitation of an injured athlete; 17-question survey with a total score calculated after inversion of the individual scores of items 4, 8, 12, and 16 (all questions are scored on a scale of 1-4 points).
Through study completion, an average of 1 year
Sports Participation Assessment
Time Frame: Through study completion, an average of 1 year
Quantifies the participant's participation in sports activity during the rehabilitation period
Through study completion, an average of 1 year
Reinjury Assessment
Time Frame: Through study completion, an average of 1 year
Monthly questionnaire to assess the rate of reinjury during rehabilitation process
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
19-question form that will contribute to comprehensive data set by evaluating confidence in perfomance
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
Assesses overall health functioning and rehabilitation levels of each participant; required to ensure that a comprehensive assessment of overall functioning is reviewed. Scores range from 20 to 80, with 50 representing the average for the general population, and increases in this number over 50 represent standard deviation, and thus represent slow recovery progress in this study
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
Single question PRO with a rating of 0-100 for each participant to score their current functioning in comparison to their pre-injury level of function
Every month, up to 1 year; assessing for change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrews Research & Education Foundation

Collaborators

Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

September 30, 2022

First Submitted That Met QC Criteria

October 10, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Return to Sport

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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