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Return to Play Checklist

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ClinicalTrials.gov Identifier: NCT04278716
Recruitment Status : Enrolling by invitation
First Posted : February 20, 2020
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

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

Condition or disease Intervention/treatment
Labral Tear, Glenoid Other: Safe return to play checklist

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safe Return to Play Following Surgery for Labral Repair: Development and Validation of a Return to Play Checklist
Actual Study Start Date : May 14, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : June 2021

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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All athletes undergoing arthroscopic capsulolabral repair surgery will be eligible for participation
Criteria

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04278716


Locations
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United States, New Jersey
Rothman Orthopaedics at Egg Harbor Township
Egg Harbor Township, New Jersey, United States, 08234
Sponsors and Collaborators
Rothman Institute Orthopaedics
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04278716    
Other Study ID Numbers: 2020 TJ 04
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries