Safe Return to Play After ACL Reconstruction

ACL Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04827264
• Other study ID #: KFREE16D.026
• Status: Completed
• Start date: February 20, 2016
• Est. completion date: February 20, 2020

Study information

• Verified date: March 2021
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: February 20, 2020
• Est. primary completion date: February 20, 2020
• Gender: All
• Age group: 15 Years to 35 Years

Eligibility

Inclusion Criteria:

• All patients ages 15-35 undergoing primary ACL reconstruction

Exclusion Criteria:

• patients who are undergoing revision ACL surgery

Related Conditions & MeSH terms

• ACL Tear
• Anterior Cruciate Ligament Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Return to Play	Participants will be evaluated prior to returning to sports using the "return to play checklist	7 months