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Safe Return to Play After ACL Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04827264
Recruitment Status : Completed
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Brief Summary:

Recent studies report that as few as 44% of athletes undergoing ACL reconstruction were able to return to their prior level of competitive level of sports. Early return may predispose an individual to re-injury including graft re-tear, meniscal tears, chondral injuries, and contralateral knee injuries. Criteria governing clearance to return to sports after ACL reconstruction has been traditionally defined using time from surgery and one or two objective criteria, often solely isokinetic quad/hamstring strength. Several studies have suggested that historical criteria used to assess readiness to return to play (RTP) are insufficient in identifying individuals at risk of a re-injury. They advocate for additional functional and dynamic testing, which may better reflect the complex kinematics required in high level athletic competition.

We previously developed a "Safe Return to Play Following ACL Reconstruction Checklist" based on a systematic review of the literature and expert survey. Seven objective measures were developed as part of the checklist. The checklist is performed by a certified physical therapist trained in these performance tests.

The purpose of this study is to validate the utility of our "Return to Play Checklist" by evaluating our patients prospectively for return to play following ACL reconstruction by comparing a cohort of patient undergoing testing with the checklist versus "clinical judgement."


Condition or disease Intervention/treatment
ACL Tear Diagnostic Test: Safe Return to Play Following ACL Reconstruction Checklist

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Study Type : Observational
Actual Enrollment : 222 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safe Return to Play Following ACL Reconstruction: Validation of a Return to Play Checklist
Actual Study Start Date : February 20, 2016
Actual Primary Completion Date : February 20, 2020
Actual Study Completion Date : February 20, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Return to Play Testing using Checklist
Participants will be evaluated prospectively for return to play following ACL reconstruction by testing with the "Safe return to play following ACL reconstruction checklist"
Diagnostic Test: Safe Return to Play Following ACL Reconstruction Checklist
All participants who have undergone primary ACL reconstruction will receive PT evaluation using our "Return to Play Checklist" at 7 months post-op, prior to return to sports

Return to Play Testing using Clinical Judgment
Participants will be evaluated prospectively for return to play following ACL reconstruction by testing with clinical judgement



Primary Outcome Measures :
  1. Return to Play [ Time Frame: 7 months ]
    Participants will be evaluated prior to returning to sports using the "return to play checklist



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Participants ages 15-35 who have undergone primary ACL reconstruction at Rothman Orthopaedics
Criteria

Inclusion Criteria:

  • All patients ages 15-35 undergoing primary ACL reconstruction

Exclusion Criteria:

  • patients who are undergoing revision ACL surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04827264


Locations
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United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04827264    
Other Study ID Numbers: KFREE16D.026
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries