TerminatedNot Applicable

MDR SureLock All-Suture Anchor

Stopped: The Sponsor decided that the CE marking would not be renewed, and therefore there was no longer a need to continue the study as the data was no longer necessary.

United States24 participantsStarted 2019-11-05

Plain-language 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.

Who can participate

Age range

14 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Device Performance and Benefits assessed through improvements in shoulder function

Timeframe: Out to 1 year post-op

Device Performance and Benefits assessed through improvements in shoulder function

Timeframe: Out to 1 year post-op

Trial details

NCT IDNCT04093700

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-11-08

View on ClinicalTrials.gov More Shoulder Pain trials

Who can participate

Age range

14 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.