Andrews Return to Sport ACL Score

ACL Injury Clinical Trial

Official title:

The Andrews Return to Sport ACL Score: A Developmental Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05578248
• Other study ID #: Return to Sport
• Status: Recruiting
• Start date: February 3, 2022
• Est. completion date: June 2023

Study information

• Verified date: October 2022
• Source: Andrews Research & Education Foundation
• Contact: Jessi Truett, MA, BCBA
• Phone: (850) 916-8570
• Email: jessica.truett[@]andrewsref.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Andrews Research and Education Foundation	Gulf Breeze	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Andrews Research & Education Foundation	Florida

Country where clinical trial is conducted

United States, 

References & Publications (17)

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. Review. — View Citation

Bodor M. Quadriceps protects the anterior cruciate ligament. J Orthop Res. 2001 Jul;19(4):629-33. — View Citation

Boyle, M. & Galway, B.(n.d.). Evidence-based Clinical Protocols: Anterior Cruciate Ligament Injury & Reconstruction. Biodex Medical Systems, Inc.

Brodke DJ, Saltzman CL, Brodke DS. PROMIS for Orthopaedic Outcomes Measurement. J Am Acad Orthop Surg. 2016 Nov;24(11):744-749. — View Citation

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. Review. — View Citation

Davies 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. Review. — View Citation

Gianotti 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. — View Citation

Gokeler 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. — View Citation

Griffin 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. Review. — View Citation

Grindem 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. — View Citation

Jordan 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. — View Citation

Lohmander 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. Epub 2007 Aug 29. Review. — View Citation

Lundberg 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. Review. — View Citation

Manske, 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.

O'Connor CM, Ring D. Correlation of Single Assessment Numeric Evaluation (SANE) with other Patient Reported Outcome Measures (PROMs). Arch Bone Jt Surg. 2019 Jul;7(4):303-306. Review. — View Citation

Wilk KE, Macrina LC, Cain EL, Dugas JR, Andrews JR. Recent advances in the rehabilitation of anterior cruciate ligament injuries. J Orthop Sports Phys Ther. 2012 Mar;42(3):153-71. doi: 10.2519/jospt.2012.3741. Epub 2012 Feb 29. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Through study completion, an average of 1 year
Primary	Sports Participation Assessment	Quantifies the participant's participation in sports activity during the rehabilitation period	Through study completion, an average of 1 year
Primary	Reinjury Assessment	Monthly questionnaire to assess the rate of reinjury during rehabilitation process	Through study completion, an average of 1 year
Primary	International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)	19-question form that will contribute to comprehensive data set by evaluating confidence in perfomance	Every month, up to 1 year; assessing for change
Primary	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	Every month, up to 1 year; assessing for change
Primary	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	Every month, up to 1 year; assessing for change