Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
24 participants
OBSERVATIONAL
2019-11-05
2022-11-08
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
OTHER
Study Groups
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SureLock All-Suture Anchor
Subjects that have been implanted with the SureLock All-Suture Anchor to repair the glenoid labrum
SureLock All-Suture Anchor
Subjects that have been implanted with the SureLock All-Suture Anchor to repair the glenoid labrum
Interventions
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SureLock All-Suture Anchor
Subjects that have been implanted with the SureLock All-Suture Anchor to repair the glenoid labrum
Eligibility Criteria
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Inclusion Criteria
* 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 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
14 Years
45 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Locations
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MedStar Health Research Institute
Lutherville, Maryland, United States
Countries
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Other Identifiers
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MDRG2017-89MS-90SM
Identifier Type: -
Identifier Source: org_study_id
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