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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04093700
Other study ID # MDRG2017-89MS-90SM
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 5, 2019
Est. completion date November 8, 2022

Study information

Verified date August 2023
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
SureLock All-Suture Anchor
Subjects that have been implanted with the SureLock All-Suture Anchor to repair the glenoid labrum

Locations

Country Name City State
United States MedStar Health Research Institute Lutherville Maryland

Sponsors (1)

Lead Sponsor Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

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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