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.
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.
Study Type
OBSERVATIONAL
Enrollment
24
Subjects that have been implanted with the SureLock All-Suture Anchor to repair the glenoid labrum
MedStar Health Research Institute
Lutherville, Maryland, United States
Device Performance and Benefits assessed through improvements in shoulder function
Patients undergoing isolated anterior or posterior glenoid labrum repair using the SureLock All-Suture Anchor will experience statistically significant improvement in shoulder function assessed through the Western Ontario Shoulder Instability Index (WOSI) outcome measure. The WOSI is a 21-item scale used to measure shoulder related quality of life in patients with symptomatic shoulder instability.
Time frame: Out to 1 year post-op
Device Performance and Benefits assessed through improvements in shoulder function
Patients undergoing isolated anterior or posterior glenoid labrum repair using the SureLock All-Suture Anchor will experience statistically significant improvement in shoulder function assessed through the American Shoulder and Elbow Surgeon Score(ASES) outcome measure. The ASES is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder.
Time frame: Out to 1 year post-op
Device Benefits assessed through improvements of health-related quality of life.
Patients undergoing isolated anterior or posterior glenoid labrum repair using the SureLock All-Suture Anchor will experience statistically significant improvement of health-related quality of life through the SF-12. The SF-12 is a short survey that is weighted and summed to provide easily interpretable scaled for physical and mental health. The range is from 0-100, 0 being the lowest level of health and 100 indicates the highest level of health.
Time frame: Out to 1 year post-op
Device Safety and Performance assessed through the frequency and incidence of revisions, complications and Adverse Events.
The assessment of safety and performance will be evaluated by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and Adverse Events. Relation of the events to either implant or instrumentation should be specified.
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Time frame: Out to 1 year post-op