Status:
TERMINATED
MDR SureLock All-Suture Anchor
Lead Sponsor:
Zimmer Biomet
Conditions:
Shoulder Pain
Shoulder Injuries
Eligibility:
All Genders
14-45 years
Brief Summary
To report the outcomes of a series of patients with recurrent anterior and/or posterior shoulder instability who underwent surgical repair of the affected labrum using the SureLock all-suture anchor.
Detailed Description
Patient-reported outcomes data have been collected among patients undergoing shoulder labrum repair with SureLock all-suture anchors from January 2014 to June 30, 2020. These patients have completed c...
Eligibility Criteria
Inclusion
- 14 to 45 years of age
- Surgery performed between 1/1/14-12/31/2021
- Recurrent shoulder instability resulting from an isolated anterior and/or posterior glenoid labral tear
- Completed pre-operative data (WOSI, ASES, SF-12)
Exclusion
- Diagnosis of concomitant SLAP tear
- Diagnosis of concomitant full-thickness rotator cuff tear
- Greater than 10% loss of glenoid bone
- Greater than 25% humeral head defect
- Prior surgical intervention for the treatment of shoulder instability (in either the affected shoulder or the contralateral shoulder)
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Key Trial Info
Start Date :
November 5 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 8 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04093700
Start Date
November 5 2019
End Date
November 8 2022
Last Update
August 14 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
MedStar Health Research Institute
Lutherville, Maryland, United States, 21093