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 range14 Years – 45 Years

SexALL

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

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