Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2022-02-03
2023-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Collegiate Athletes
Group designated for collegiate athletes; see protocol for treatment plan
Magnetic Resonance Imaging (MRI)
Non-invasive imaging technology that produces three-dimensional detailed anatomical images
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
Magnetic Resonance Imaging (MRI)
Non-invasive imaging technology that produces three-dimensional detailed anatomical images
ACL reconstruction
Surgical procedure to repair damaged or severed anterior cruciate ligament in the knee
Interventions
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Magnetic Resonance Imaging (MRI)
Non-invasive imaging technology that produces three-dimensional detailed anatomical images
ACL reconstruction
Surgical procedure to repair damaged or severed anterior cruciate ligament in the knee
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
14 Years
24 Years
ALL
No
Sponsors
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Florida
OTHER
Andrews Research & Education Foundation
OTHER
Responsible Party
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Principal Investigators
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Adam Anz, MD
Role: PRINCIPAL_INVESTIGATOR
Orthopedic Surgeon
Locations
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Andrews Research and Education Foundation
Gulf Breeze, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Boyle, 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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Return to Sport
Identifier Type: -
Identifier Source: org_study_id
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