Return to Play Checklist

February 18, 2020 updated by: Rothman Institute Orthopaedics

Safe Return to Play Following Surgery for Labral Repair: Development and Validation of a Return to Play Checklist

This study will try to develop and determine objective and validated criteria for our athletes to safely return to sports after labral repair.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

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
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • Rothman Orthopaedics at Egg Harbor Township

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 and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All athletes undergoing arthroscopic capsulolabral repair surgery will be eligible for participation

Description

Inclusion Criteria:

- Males and non-pregnant females aged 15 years or older with a capsulolabral tear undergoing arthroscopic capsulolabral repair surgery at the Rothman Institute with one of the investigators

Exclusion Criteria:

  • Patients with an labral repair
  • Patients only undergoing debridements with no repair
  • Patients undergoing revision shoulder surgery or those with a history of multiple shoulder surgeries
  • Concomitant severe glenohumeral arthritis or adhesive capsulitis
  • Patients with a worker's compensation claim
  • Patients diagnosed with psychological disorders
  • Patients with a history of alcohol or drug abuse -Patients on preoperative narcotic therapy -

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
Utilization of a safe return to play checklist
Athletes who were treated for a capsulolabral tear who have undergone arthroscopic capsulolabral repair surgery will be evaluated using an objective checklist prior to being allowed to return to their sport. The utilization and outcome of using this checklist will be evaluated
Other: Safe return to play checklist
this objective checklist will be utilized by the physical therapy staff and surgeon to determine whether an athlete is safe to return to their sport

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful completion of the return to play checklist
Time Frame: 1 year post-surgery
This outcome measure will count the number of patients who meet all the criteria in the return to play checklist prior to returning to their sport
1 year post-surgery

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)

May 14, 2018

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

February 18, 2020

First Submitted That Met QC Criteria

February 18, 2020

First Posted (Actual)

February 20, 2020

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020 TJ 04

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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