The Andrews Return to Sport ACL Score: A Developmental Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 14 Years to 24 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
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
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).
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
Reinjury Assessment
Time Frame: Through study completion, an average of 1 year
Monthly questionnaire to assess the rate of reinjury during rehabilitation process
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
Secondary Outcomes
No secondary outcomes reported