Clinical Trial on the Effect of the Flexible Suturing System With Anchors (FSSA) in Full-thickness Rotator Cuff Tendon Tears

NCT06868108 | Enrolling By Invitation FDA Device

• 1 other identifier: DN-00808
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this research study is to evaluate tendon healing when using the Flexible Suturing System with Anchors (FSSA) to surgically repair full-thickness rotator cuff tendon tears.

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• Healing Rate

  The cumulative healing rate of the repaired rotator cuff tendon, confirmed through MRI, studied one year after the intervention and using the Sugaya classification (Sugaya H (2005)), where healing is defined as Sugaya Type I, II, or III.

  One year

Interventions

Flexible Suturing System with Anchors (FSSA) DEVICE

Surgically repaired full-thickness rotator cuff tendon tears with the Flexible Suturing System with Anchors (FSSA).

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

An individual that underwent surgery to repair a torn rotator cuff tear with the Flexible Suturing System with Anchors (FSSA).

You may qualify if:

• Subjects MUST meet ALL the following criteria to be included in the study:
• Underwent surgery to repair a torn rotator cuff tear with the Flexible Suturing System with Anchors (FSSA) and is able to obtain a follow-up MRI within 12 months +4 months / -1 month from the surgery date.
• Tear size of the supraspinatus (SSP) with or without involvement of the infraspinatus (ISP), confirmed intra-operatively or with the pre-procedural MRI, is greater than or equal to 1 cm.
• Between 18 and 70 years old at the time of surgery.
• Able to understand the content of the subject information / Informed Consent Form (ICF) and is willing and able to participate in the prospective data collection protocol and comply with the required data collection.

You may not qualify if:

• Subjects will be excluded from the study if they meet ANY of the following criteria:
• Had a prior rotator cuff surgery on the index shoulder.
• Has a subscapularis tear with a Lafosse score of 3 or greater, or a teres minor tear requiring repair.
• Identified as being repaired in a hybrid approach, where a non-FSSA anchor is used in the case for SSP and/or ISP rotator cuff repair.
• SSP and / or ISP tendon ruptures that are considered irreparable or only partially repairable at the time of the intervention.
• At any time during the previous 18 months was involved in a workers compensation case or litigation related to bodily injury, whether related or unrelated to the index shoulder.
• Has a history of chronic opioid use.
• Subjects with condition(s) that contraindicate or complicate outcomes of ARCR such as:
• Current or prior infection of the ipsilateral shoulder
• Known inflammatory arthropathy or history of inflammatory arthropathy
• Chronic joint disease
• Concomitant labral fixation
• Concomitant os acromial fixation
• Glenohumeral joint instability (multiple dislocations/subluxations)
• Subacromial or intra-articular injection within 3 months prior to surgery

Sponsors & Collaborators

• Integrity Orthopaedics, Inc.: lead

Study Sites (3)

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

Texas Orthopedic Specialist

Bedford, Texas, 76021, United States

Location

Houston Methodist The Woodlands

The Woodlands, Texas, 77385, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 10, 2025
• Study Start: February 20, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)