Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04278716
Other study ID # 2020 TJ 04
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 14, 2018
Est. completion date June 2021

Study information

Verified date February 2020
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

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 -

Study Design


Related Conditions & MeSH terms


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

Locations

Country Name City State
United States Rothman Orthopaedics at Egg Harbor Township Egg Harbor Township New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT04094701 - Hip Arthroscopy Postoperative Opioid Demands N/A
Terminated NCT04093700 - MDR SureLock All-Suture Anchor
Enrolling by invitation NCT05974423 - Randomized Trial of Narcotic vs Non-Narcotic Pain Modulation After Labrum Repair Phase 4
Recruiting NCT04113759 - Blood Flow Restriction Following Hip Arthroscopy N/A
Active, not recruiting NCT03985839 - Safety and Performance of MICRORAPTORâ„¢ Suture Anchors in Shoulder and Hip
Not yet recruiting NCT06043791 - Applicability of 3T Shoulder MRI in Detection of Labral Pathology N/A