MDR SureLock All-Suture Anchor

Shoulder Pain Clinical Trial

Official title:

Clinical Outcomes of Surgical Repair of the Glenoid Labrum Using an All-Suture Anchor

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04093700
• Other study ID #: MDRG2017-89MS-90SM
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Labral Tear, Glenoid
• Rotator Cuff Injuries
• Shoulder Disease
• Shoulder Injuries
• Shoulder Pain
• Shoulder Pain Chronic
• Shoulder Syndrome

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