Labral Tear, Glenoid, Shoulder Disease, Shoulder Injuries, Shoulder Pain, Shoulder Pain Chronic, Shoulder Syndrome
Conditions
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 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.
Interventions
DEVICESureLock All-Suture Anchor
Subjects that have been implanted with the SureLock All-Suture Anchor to repair the glenoid labrum
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
14 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Performance and Benefits assessed through improvements in shoulder function | Out to 1 year post-op | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Benefits assessed through improvements of health-related quality of life. | Out to 1 year post-op | 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. |
| Device Safety and Performance assessed through the frequency and incidence of revisions, complications and Adverse Events. | Out to 1 year post-op | 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. |
Countries
United States
Outcome results
None listed