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NCT04827264 · ClinicalTrials.gov registry record
Safe Return to Play After ACL Reconstruction
A clinical trial, sponsored by Rothman Institute Orthopaedics.
- Completed
- Registry status
- 222
- Enrollment target
NCT04827264: Completed study, sponsored by Rothman Institute Orthopaedics.
NCT04827264 is a clinical trial that has completed, run by Rothman Institute Orthopaedics. The registered enrollment target is 222 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04827264 has completed, sponsored by Rothman Institute Orthopaedics.
- COMPLETED
- Registry status
- 222 participants
- Enrollment target
Study 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."
Primary Outcome
Participants will be evaluated prior to returning to sports using the "return to play checklist
Interventions
- DIAGNOSTIC_TEST Safe Return to Play Following ACL Reconstruction Checklist
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2016-02-20 |
| Est. Completion | 2020-02-20 |
What the finished NCT04827264 record still lists
NCT04827264 is an observational study that tracks outcomes without assigning an intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Safe Return to Play Following ACL Reconstruction Checklist is the first listed.
NCT04827264 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04827264 about?
NCT04827264 is a clinical study titled "Safe Return to Play After ACL Reconstruction". 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 injuri...
What is the current status of trial NCT04827264?
This trial is currently completed. The enrollment target is 222 participants. The study started on 2016-02-20. Estimated completion is 2020-02-20.
What interventions are being tested in trial NCT04827264?
The interventions under investigation include: Safe Return to Play Following ACL Reconstruction Checklist (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04827264?
This trial is sponsored by Rothman Institute Orthopaedics, which has 23 total clinical trials registered on ClinicalTrials.gov.
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