Labral Tear, Glenoid Clinical Trial
Official title:
Safe Return to Play Following Surgery for Labral Repair: Development and Validation of a Return to Play Checklist
| Verified date | February 2020 |
| Source | Rothman Institute Orthopaedics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This study will try to develop and determine objective and validated criteria for our athletes to safely return to sports after labral repair.
| Status | Enrolling by invitation |
| Enrollment | 1000 |
| Est. completion date | June 2021 |
| Est. primary completion date | May 2021 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 15 Years and older |
| Eligibility |
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 - |
| Country | Name | City | State |
|---|---|---|---|
| United States | Rothman Orthopaedics at Egg Harbor Township | Egg Harbor Township | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Rothman Institute Orthopaedics |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
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