ACL InjuryNCT05578248
Andrews Return to Sport ACL Score
An observational study of ACL Injury, run by Andrews Research & Education Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 24 years
- Conditions the study is for
- ACL Injury
- What is being tested?
- Magnetic Resonance Imaging (MRI) and ACL reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2022to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 100 competitive pre-collegiate or collegiate athletes who have recently suffered from an ACL injury that requires reconstructive surgery
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Andrews Research and Education Foundation
Gulf Breeze, Florida, 32561
Jessi Truett, MA, BCBA, 850-916-8570, jessica.truett@andrewsref.org
Chandler Bridges, MS, 8509168584, chandler.bridges@andrewsref.org
About this study
Official title: 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.
Read the 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
- Being tested
- Magnetic Resonance Imaging (MRI), ACL reconstruction
- Keywords
- Cohort, return to sport
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Diagnostic test
Non-invasive imaging technology that produces three-dimensional detailed anatomical images
ACL reconstructionProcedure or surgery
Surgical procedure to repair damaged or severed anterior cruciate ligament in the knee
| Study group | Role | What they receive |
|---|---|---|
| Collegiate Athletes | Group designated for collegiate athletes; see protocol for treatment plan Receives: Diagnostic Test: Magnetic Resonance Imaging (MRI); Procedure: ACL reconstruction | |
| Pre-collegiate Athletes | Group designated for pre-collegiate, or high school-age, athletes; see protocol for treatment plan Receives: Diagnostic Test: Magnetic Resonance Imaging (MRI); Procedure: ACL reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tampa Scale for Kinesiophobia
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).
Measured: Through study completion, an average of 1 year
Sports Participation Assessment
Quantifies the participant's participation in sports activity during the rehabilitation period
Measured: Through study completion, an average of 1 year
Reinjury Assessment
Monthly questionnaire to assess the rate of reinjury during rehabilitation process
Measured: Through study completion, an average of 1 year
International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)
19-question form that will contribute to comprehensive data set by evaluating confidence in perfomance
Measured: Every month, up to 1 year; assessing for change
Patient Reported Outcomes Measurement Information Systems (PROMIS)
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
Measured: Every month, up to 1 year; assessing for change
Single Assessment Numeric Evaluation (SANE)
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
Measured: Every month, up to 1 year; assessing for change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start3 Feb 2022
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrews Research & Education Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Florida
- Responsible party
- Sponsor
- Investigators
- Adam Anz, MD, Principal investigator, Orthopedic Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578248
- Sponsor's protocol ID
- Return to Sport
- Status last verified
- Oct 2022
- First submitted
- 30 Sep 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ardern CL, Taylor NF, Feller JA, Webster KE. Fifty-five per cent return to competitive sport following anterior cruciate ligament reconstruction surgery: an updated systematic review and meta-analysis including aspects of physical functioning and contextual factors. Br J Sports Med. 2014 Nov;48(21):1543-52. doi: 10.1136/bjsports-2013-093398. Epub 2014 Aug 25.
PubMed 25157180Bodor M. Quadriceps protects the anterior cruciate ligament. J Orthop Res. 2001 Jul;19(4):629-33. doi: 10.1016/S0736-0266(01)00050-X.
PubMed 11518272Brodke DJ, Saltzman CL, Brodke DS. PROMIS for Orthopaedic Outcomes Measurement. J Am Acad Orthop Surg. 2016 Nov;24(11):744-749. doi: 10.5435/JAAOS-D-15-00404.
PubMed 27661391Boyle, M. & Galway, B.(n.d.). Evidence-based Clinical Protocols: Anterior Cruciate Ligament Injury & Reconstruction. Biodex Medical Systems, Inc.
Creighton DW, Shrier I, Shultz R, Meeuwisse WH, Matheson GO. Return-to-play in sport: a decision-based model. Clin J Sport Med. 2010 Sep;20(5):379-85. doi: 10.1097/JSM.0b013e3181f3c0fe.
PubMed 20818198Davies GJ, McCarty E, Provencher M, Manske RC. ACL Return to Sport Guidelines and Criteria. Curr Rev Musculoskelet Med. 2017 Sep;10(3):307-314. doi: 10.1007/s12178-017-9420-9.
PubMed 28702921Gianotti SM, Marshall SW, Hume PA, Bunt L. Incidence of anterior cruciate ligament injury and other knee ligament injuries: a national population-based study. J Sci Med Sport. 2009 Nov;12(6):622-7. doi: 10.1016/j.jsams.2008.07.005. Epub 2008 Oct 2.
PubMed 18835221Griffin LY, Agel J, Albohm MJ, Arendt EA, Dick RW, Garrett WE, Garrick JG, Hewett TE, Huston L, Ireland ML, Johnson RJ, Kibler WB, Lephart S, Lewis JL, Lindenfeld TN, Mandelbaum BR, Marchak P, Teitz CC, Wojtys EM. Noncontact anterior cruciate ligament injuries: risk factors and prevention strategies. J Am Acad Orthop Surg. 2000 May-Jun;8(3):141-50. doi: 10.5435/00124635-200005000-00001.
PubMed 10874221Grindem H, Snyder-Mackler L, Moksnes H, Engebretsen L, Risberg MA. Simple decision rules can reduce reinjury risk by 84% after ACL reconstruction: the Delaware-Oslo ACL cohort study. Br J Sports Med. 2016 Jul;50(13):804-8. doi: 10.1136/bjsports-2016-096031. Epub 2016 May 9.
PubMed 27162233Gokeler A, Welling W, Zaffagnini S, Seil R, Padua D. Development of a test battery to enhance safe return to sports after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2017 Jan;25(1):192-199. doi: 10.1007/s00167-016-4246-3. Epub 2016 Jul 16.
PubMed 27423208Jordan MJ, Morris N, Lane M, Barnert J, MacGregor K, Heard M, Robinson S, Herzog W. Monitoring the Return to Sport Transition After ACL Injury: An Alpine Ski Racing Case Study. Front Sports Act Living. 2020 Mar 3;2:12. doi: 10.3389/fspor.2020.00012. eCollection 2020.
PubMed 33345007Lohmander LS, Englund PM, Dahl LL, Roos EM. The long-term consequence of anterior cruciate ligament and meniscus injuries: osteoarthritis. Am J Sports Med. 2007 Oct;35(10):1756-69. doi: 10.1177/0363546507307396. Epub 2007 Aug 29.
PubMed 17761605Lundberg M, Styf J, Jansson B. On what patients does the Tampa Scale for Kinesiophobia fit? Physiother Theory Pract. 2009 Oct;25(7):495-506. doi: 10.3109/09593980802662160.
PubMed 19925172Manske, R. & Reiman, M. (2013). Functional Performance Testing for Power and Return to Sport. Athletic Training. Functional Testing in Human Performance. DOI: 10.1177/1941738113479925
Miller RP, Kori S, Todd D. The Tampa Scale: a measure of kinesiophobia. Clin J Pain. 1991;7(1):51-52.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Andrews Return to Sport ACL Score: A Developmental Study
- ClinicalTrials.gov ID
- NCT05578248
- Acronym / sponsor ID
- Return to Sport
- Conditions
- ACL Injury
- Keywords
- Cohort, return to sport
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Andrews Research & Education FoundationUniversity, hospital or other
- Collaborators
- Florida
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collegiate Athletes | – | Diagnostic Test: Magnetic Resonance Imaging (MRI), Procedure: ACL reconstructionGroup designated for collegiate athletes; see protocol for treatment plan |
| Pre-collegiate Athletes | – | Diagnostic Test: Magnetic Resonance Imaging (MRI), Procedure: ACL reconstructionGroup designated for pre-collegiate, or high school-age, athletes; see protocol for treatment plan |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 100 competitive pre-collegiate or collegiate athletes who have recently suffered from an ACL injury that requires reconstructive surgery
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI)Non-invasive imaging technology that produces three-dimensional detailed anatomical images | Diagnostic test | Collegiate Athletes, Pre-collegiate Athletes |
| ACL reconstructionSurgical procedure to repair damaged or severed anterior cruciate ligament in the knee | Procedure or surgery | Collegiate Athletes, Pre-collegiate Athletes |
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Background: PubMed 25157180Ardern CL, Taylor NF, Feller JA, Webster KE. Fifty-five per cent return to competitive sport following anterior cruciate ligament reconstruction surgery: an updated systematic review and meta-analysis including aspects of physical functioning and contextual factors. Br J Sports Med. 2014 Nov;48(21):1543-52. doi: 10.1136/bjsports-2013-093398. Epub 2014 Aug 25.
- Background: PubMed 11518272Bodor M. Quadriceps protects the anterior cruciate ligament. J Orthop Res. 2001 Jul;19(4):629-33. doi: 10.1016/S0736-0266(01)00050-X.
- Background: PubMed 27661391Brodke DJ, Saltzman CL, Brodke DS. PROMIS for Orthopaedic Outcomes Measurement. J Am Acad Orthop Surg. 2016 Nov;24(11):744-749. doi: 10.5435/JAAOS-D-15-00404.
- BackgroundBoyle, M. & Galway, B.(n.d.). Evidence-based Clinical Protocols: Anterior Cruciate Ligament Injury & Reconstruction. Biodex Medical Systems, Inc.
- Background: PubMed 20818198Creighton DW, Shrier I, Shultz R, Meeuwisse WH, Matheson GO. Return-to-play in sport: a decision-based model. Clin J Sport Med. 2010 Sep;20(5):379-85. doi: 10.1097/JSM.0b013e3181f3c0fe.
- Background: PubMed 28702921Davies GJ, McCarty E, Provencher M, Manske RC. ACL Return to Sport Guidelines and Criteria. Curr Rev Musculoskelet Med. 2017 Sep;10(3):307-314. doi: 10.1007/s12178-017-9420-9.
- Background: PubMed 18835221Gianotti SM, Marshall SW, Hume PA, Bunt L. Incidence of anterior cruciate ligament injury and other knee ligament injuries: a national population-based study. J Sci Med Sport. 2009 Nov;12(6):622-7. doi: 10.1016/j.jsams.2008.07.005. Epub 2008 Oct 2.
- Background: PubMed 10874221Griffin LY, Agel J, Albohm MJ, Arendt EA, Dick RW, Garrett WE, Garrick JG, Hewett TE, Huston L, Ireland ML, Johnson RJ, Kibler WB, Lephart S, Lewis JL, Lindenfeld TN, Mandelbaum BR, Marchak P, Teitz CC, Wojtys EM. Noncontact anterior cruciate ligament injuries: risk factors and prevention strategies. J Am Acad Orthop Surg. 2000 May-Jun;8(3):141-50. doi: 10.5435/00124635-200005000-00001.
- Background: PubMed 27162233Grindem H, Snyder-Mackler L, Moksnes H, Engebretsen L, Risberg MA. Simple decision rules can reduce reinjury risk by 84% after ACL reconstruction: the Delaware-Oslo ACL cohort study. Br J Sports Med. 2016 Jul;50(13):804-8. doi: 10.1136/bjsports-2016-096031. Epub 2016 May 9.
- Background: PubMed 27423208Gokeler A, Welling W, Zaffagnini S, Seil R, Padua D. Development of a test battery to enhance safe return to sports after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2017 Jan;25(1):192-199. doi: 10.1007/s00167-016-4246-3. Epub 2016 Jul 16.
- Background: PubMed 33345007Jordan MJ, Morris N, Lane M, Barnert J, MacGregor K, Heard M, Robinson S, Herzog W. Monitoring the Return to Sport Transition After ACL Injury: An Alpine Ski Racing Case Study. Front Sports Act Living. 2020 Mar 3;2:12. doi: 10.3389/fspor.2020.00012. eCollection 2020.
- Background: PubMed 17761605Lohmander LS, Englund PM, Dahl LL, Roos EM. The long-term consequence of anterior cruciate ligament and meniscus injuries: osteoarthritis. Am J Sports Med. 2007 Oct;35(10):1756-69. doi: 10.1177/0363546507307396. Epub 2007 Aug 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Anz, MD principal investigator
Orthopedic Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACL Injury, run by Andrews Research & Education Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessi Truett, MA, BCBA ((850) 916-8570, jessica.truett@andrewsref.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tampa Scale for Kinesiophobia (time frame: Through study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05578248, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.