NCT04827264

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."

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

4 years

First QC Date

March 31, 2021

Last Update Submit

March 31, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Return to Play

    Participants will be evaluated prior to returning to sports using the "return to play checklist

    7 months

Study Arms (2)

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

Return to Play Testing using Clinical Judgment

Participants will be evaluated prospectively for return to play following ACL reconstruction by testing with clinical judgement

Interventions

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 Checklist

Eligibility Criteria

Age15 Years - 35 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • All patients ages 15-35 undergoing primary ACL reconstruction

You may not qualify if:

  • patients who are undergoing revision ACL surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

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

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 1, 2021

Study Start

February 20, 2016

Primary Completion

February 20, 2020

Study Completion

February 20, 2020

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations