MDR SureLock All-Suture Anchor

NCT04093700 | Terminated FDA Device

• 1 other identifier: MDRG2017-89MS-90SM
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain; Shoulder Injuries; Shoulder Disease; Shoulder Pain Chronic; Shoulder Syndrome; Labral Tear, Glenoid

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Device Benefits assessed through improvements of health-related quality of life.

  Out to 1 year post-op

• Device Safety and Performance assessed through the frequency and incidence of revisions, complications and Adverse Events.

  Out to 1 year post-op

Study Arms (1)

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

Interventions

SureLock All-Suture Anchor DEVICE

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

SureLock All-Suture Anchor

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

MedStar Health Research Institute

Lutherville, Maryland, 21093, United States

Location

MeSH Terms

Conditions

Shoulder Pain; Shoulder Injuries; Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Rupture; Tendon Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: September 18, 2019
• Study Start: November 5, 2019
• Primary Completion: November 8, 2022
• Study Completion: November 8, 2022
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)