NCT04093700

MDR SureLock All-Suture Anchor

Clinical Outcomes of Surgical Repair of the Glenoid Labrum Using an All-Suture Anchor

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 14 Years – 45 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Shoulder Pain
• Shoulder Injuries
• Shoulder Disease
• Shoulder Pain Chronic
• Shoulder Syndrome
• Labral Tear, Glenoid

Interventions

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

Timeline

• Start date: 2019-11-05
• Primary completion: 2022-11-08
• Completion: 2022-11-08
• First posted: 2019-09-18
• Last updated: 2023-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study