MDR SureLock All-Suture Anchor

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

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.

Study Overview

• Status: Terminated
• Conditions: Shoulder Injuries; Shoulder Pain; Labral Tear, Glenoid; Shoulder Disease; Shoulder Syndrome; Shoulder Pain Chronic
• Intervention / Treatment: Device: 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.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Lutherville, Maryland, United States, 21093
      • Medstar Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SureLock All-Suture Anchor; Subjects that have been implanted with the SureLock All-Suture Anchor to repair the glenoid labrum	Device: SureLock All-Suture Anchor; Subjects that have been implanted with the SureLock All-Suture Anchor to repair the glenoid labrum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Kacy Arnold, MBA, RN, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2019
• Primary Completion (Actual): November 8, 2022
• Study Completion (Actual): November 8, 2022

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 18, 2019

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rupture; Tendon Injuries; Arthralgia; Rotator Cuff Injuries; Shoulder Pain; Shoulder Injuries
• Other Study ID Numbers: MDRG2017-89MS-90SM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes