Safe Return to Play After ACL Reconstruction

March 31, 2021 updated by: Rothman Institute Orthopaedics

Safe Return to Play Following ACL Reconstruction: Validation of a Return to Play Checklist

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."

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

222

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Rothman Orthopaedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants ages 15-35 who have undergone primary ACL reconstruction at Rothman Orthopaedics

Description

Inclusion Criteria:

  • All patients ages 15-35 undergoing primary ACL reconstruction

Exclusion Criteria:

  • patients who are undergoing revision ACL surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Return to Play
Time Frame: 7 months
Participants will be evaluated prior to returning to sports using the "return to play checklist
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rothman Institute Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2016

Primary Completion (Actual)

February 20, 2020

Study Completion (Actual)

February 20, 2020

Study Registration Dates

First Submitted

March 31, 2021

First Submitted That Met QC Criteria

March 31, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 31, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KFREE16D.026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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