NCT04278716

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

3 years

First QC Date

February 18, 2020

Last Update Submit

February 18, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Successful completion of the return to play checklist

    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

Study Arms (1)

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

Interventions

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

Utilization of a safe return to play checklist

Eligibility Criteria

Age15 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \- 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

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Orthopaedics at Egg Harbor Township

Egg Harbor, New Jersey, 08234, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 20, 2020

Study Start

May 14, 2018

Primary Completion

May 1, 2021

Study Completion

June 1, 2021

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations