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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Device: Flexible Suturing System with Anchors (FSSA)

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina Research Institute
  • Texas
    • Bedford, Texas, United States, 76021
      • Texas Orthopedic Specialist
    • The Woodlands, Texas, United States, 77385
      • Houston Methodist The Woodlands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

Inclusion Criteria:

Subjects MUST meet ALL the following criteria to be included in the study:

1. 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.
2. 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.
3. Between 18 and 70 years old at the time of surgery.
4. 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.

Exclusion Criteria:

Subjects will be excluded from the study if they meet ANY of the following criteria:

1. Had a prior rotator cuff surgery on the index shoulder.
2. Has a subscapularis tear with a Lafosse score of 3 or greater, or a teres minor tear requiring repair.
3. 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.
4. SSP and / or ISP tendon ruptures that are considered irreparable or only partially repairable at the time of the intervention.
5. 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.
6. Has a history of chronic opioid use.

7. 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
   • Oral or injected steroid use in the following timeframe: 4 weeks prior to surgery through current date
   • Hamada 3 or greater rotator cuff arthropathy on X-ray
   • Goutallier atrophy > Grade 3
   • Proximal humeral fracture or scapular fracture
   • Avascular necrosis of humeral head or glenoid
   • Immunodeficiency disorders
   • Chronic inflammatory disorders
   • Osteoarthritis >2 (Samilson-Prieto)
8. Has other concurrent medical or other conditions (chronic or acute in nature) that in the opinion of the participating investigator may prevent participation or otherwise render subject ineligible for the study.
9. Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Integrity Orthopaedics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 5, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 10, 2025

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: DN-00808

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.: No