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Return to Play Checklist

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04278716
Recruitment Status : Unknown
Verified February 2020 by Rothman Institute Orthopaedics.
Recruitment status was:  Enrolling by invitation
First Posted : February 20, 2020
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Tracking Information
First Submitted Date February 18, 2020
First Posted Date February 20, 2020
Last Update Posted Date February 20, 2020
Actual Study Start Date May 14, 2018
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 18, 2020)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Return to Play Checklist
Official Title Safe Return to Play Following Surgery for Labral Repair: Development and Validation of a Return to Play Checklist
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All athletes undergoing arthroscopic capsulolabral repair surgery will be eligible for participation
Condition Labral Tear, Glenoid
Intervention 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
Study Groups/Cohorts 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
Intervention: Other: Safe return to play checklist
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 18, 2020)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility 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 -
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04278716
Other Study ID Numbers 2020 TJ 04
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Rothman Institute Orthopaedics
Original Responsible Party Same as current
Current Study Sponsor Rothman Institute Orthopaedics
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Rothman Institute Orthopaedics
Verification Date February 2020