Safe Return to Play After ACL Reconstruction

NCT ID: NCT04827264

Last Updated: 2021-04-01

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

222 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-20

Study Completion Date

2020-02-20

Brief Summary

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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."

Detailed Description

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Conditions

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ACL Tear

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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"

Safe Return to Play Following ACL Reconstruction Checklist

Intervention Type DIAGNOSTIC_TEST

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

No interventions assigned to this group

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* All patients ages 15-35 undergoing primary ACL reconstruction

Exclusion Criteria

* patients who are undergoing revision ACL surgery
Minimum Eligible Age

15 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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KFREE16D.026

Identifier Type: -

Identifier Source: org_study_id

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