MDR SureLock All-Suture Anchor

Zimmer Biomet

Status: Terminated

Conditions: Shoulder Syndrome; Shoulder Pain; Shoulder Injuries; Shoulder Pain Chronic; Labral Tear, Glenoid; Shoulder Disease

Treatments: Device: SureLock All-Suture Anchor

Study type: Observational

Funder types: Industry

Identifiers

NCT04093700

MDRG2017-89MS-90SM

Details and patient eligibility

About

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.

Full 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 clinical and quality-of-life outcome instruments pre-operatively, and have been stored securely in the OBERD database. Pre-op scores will be compared to post-op scores and analyzed using a one-way ANOVA test with a post-hoc Scheffe procedure.

Patient identifying information will be removed and de-identified codes will be used. Any new prospective data gathered prospectively for the purposes of this study will be entered and stored securely as above.

Data collection forms will consist of the following Patient-Reported Outcome Surveys: WOSI Index, ASES Shoulder Score, and the SF-12.

Enrollment: 24 patients

Sex: All

Ages: 14 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

24 participants in 1 patient group

SureLock All-Suture Anchor

Description:

Subjects that have been implanted with the SureLock All-Suture Anchor to repair the glenoid labrum

Treatment:

Device: SureLock All-Suture Anchor