Clinical trial NCT04093700: MDR SureLock All-Suture Anchor
Official title: Clinical Outcomes of Surgical Repair of the Glenoid Labrum Using an All-Suture Anchor
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Shoulder Pain
Shoulder Injuries
Shoulder Disease
Shoulder Pain Chronic
Shoulder Syndrome
Labral Tear, Glenoid
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2019-09-18
Enrollment: 24
Sex: ALL
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who underwent glenoid labrum repair with the SureLock all-suture anchors between 1/1/2014 and 12/31/2021.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Device Performance and Benefits assessed through improvements in shoulder function
timeFrame: Out to 1 year post-op
measure: Device Performance and Benefits assessed through improvements in shoulder function
timeFrame: Out to 1 year post-op
Secondary outcomes:
measure: Device Benefits assessed through improvements of health-related quality of life.
timeFrame: Out to 1 year post-op
measure: Device Safety and Performance assessed through the frequency and incidence of revisions, complications and Adverse Events.
timeFrame: Out to 1 year post-op
Other outcomes:
Locations:
city: Lutherville
country: United States
facility: MedStar Health Research Institute
state: Maryland
Study officials:
References: