Shoulder Pain Clinical Trial
Official title:
Clinical Outcomes of Surgical Repair of the Glenoid Labrum Using an All-Suture Anchor
Verified date | August 2023 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Terminated |
Enrollment | 24 |
Est. completion date | November 8, 2022 |
Est. primary completion date | November 8, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | MedStar Health Research Institute | Lutherville | Maryland |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Out to 1 year post-op | |
Primary | 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. | Out to 1 year post-op | |
Secondary | 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. | Out to 1 year post-op | |
Secondary | 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. | Out to 1 year post-op |
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