Andrews Return to Sport ACL Score

NCT05578248 | Unknown

• 1 other identifier: Return to Sport
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Cohort; return to sport

Outcome Measures

Primary Outcomes (6)

• 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

• Sports Participation Assessment

  Quantifies the participant's participation in sports activity during the rehabilitation period

  Through study completion, an average of 1 year

• Reinjury Assessment

  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)

  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)

  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)

  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

Study Arms (2)

Collegiate Athletes

Group designated for collegiate athletes; see protocol for treatment plan

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

Diagnostic Test: Magnetic Resonance Imaging (MRI); Procedure: ACL reconstruction

Interventions

Magnetic Resonance Imaging (MRI) DIAGNOSTIC_TEST

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

Collegiate Athletes; Pre-collegiate Athletes

ACL reconstruction PROCEDURE

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

Collegiate Athletes; Pre-collegiate Athletes

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Andrews Research & Education Foundation: lead
• Florida: collaborator

Study Sites (1)

Andrews Research and Education Foundation

Gulf Breeze, Florida, 32561, United States

RECRUITING

Related 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.

  PMID: 25157180 BACKGROUND

• Bodor M. Quadriceps protects the anterior cruciate ligament. J Orthop Res. 2001 Jul;19(4):629-33. doi: 10.1016/S0736-0266(01)00050-X.

  PMID: 11518272 BACKGROUND

• Brodke 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.

  PMID: 27661391 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 20818198 BACKGROUND

• 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.

  PMID: 28702921 BACKGROUND

• 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.

  PMID: 18835221 BACKGROUND

• 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. doi: 10.5435/00124635-200005000-00001.

  PMID: 10874221 BACKGROUND

• 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.

  PMID: 27162233 BACKGROUND

• 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.

  PMID: 27423208 BACKGROUND

• 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.

  PMID: 33345007 BACKGROUND

• 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. doi: 10.1177/0363546507307396. Epub 2007 Aug 29.

  PMID: 17761605 BACKGROUND

• 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.

  PMID: 19925172 BACKGROUND

• Manske R, Reiman M. Functional performance testing for power and return to sports. Sports Health. 2013 May;5(3):244-50. doi: 10.1177/1941738113479925.

  PMID: 24427396 BACKGROUND

• Miller RP, Kori S, Todd D. The Tampa Scale: a measure of kinesiophobia. Clin J Pain. 1991;7(1):51-52.

  BACKGROUND

• 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.

  PMID: 31448305 BACKGROUND

• 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.

  PMID: 22382825 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Adam Anz, MD

  Orthopedic Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessi Truett, MA, BCBA

CONTACT

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

Chandler Bridges, MS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 13, 2022
• Study Start: February 3, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 13, 2022

Record last verified: 2022-10

Locations

US (1)