Integrity Implant System Post Market Clinical Follow-Up Study

November 12, 2025 updated by: Anika Therapeutics, Inc.

Post Market Confirmatory Interventional Clinical Study of the Integrity Implant System Used for Rotator Cuff Tear Augmentation

The study design is a prospective, multi-center, single-arm, non-randomized post market clinical follow-up study to confirm the performance, safety and clinical benefit of the Integrity Implant System when used for rotator cuff tear augmentation (with or without repair).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The Study Objective is to confirm the performance, safety and clinical benefit of the Integrity Implant System when used for rotator cuff tear augmentation (with or without repair).

The clinical success will be evaluated by absence of rotator cuff re-tear. Performance and clinical benefits will be evaluated by functional outcomes measured using standard scoring systems such as the American Shoulder and Elbow Surgeons Shoulder Score (ASES), Constant-Murley Score (CMS), Patient Satisfaction, EQ-5D-5L, Single Assessment Numeric Evaluation (SANE), Visual Analogue Scale (VAS) and rotator cuff repair outcomes measured using MRI evaluation for repair integrity, quality, tendon tissue thickness and regeneration.

Safety of the Integrity Implant System will be assessed by monitoring the frequency and incidence of adverse events.

The Primary Endpoint shall confirm the Performance of the Integrity Implant System when used for rotator cuff augmentation (with or without repair). Performance will be evaluated by an adequately powered analysis of retear rates seen by MRI at 12-months after surgery.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Foundation for Orthopaedic Research and Education
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christopher Baker, MD
    • Indiana
      • Fishers, Indiana, United States, 46037
        • Recruiting
        • Central Indiana Orthopaedics
        • Principal Investigator:
          • Brian Badman, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Aaron Baessler, MD
    • Maryland
      • Towson, Maryland, United States, 21204
        • Recruiting
        • Towson Orthopaedic Associates/University of Maryland St. Joseph's Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Timothy Codd, MD
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Recruiting
        • Virtua Health
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sean McMillan, DO
    • South Carolina
    • Tennessee
      • Germantown, Tennessee, United States, 38138

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  1. At least 18 years of age
  2. Able (with assistance from LAR, if necessary) to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures.
  3. Able to complete all Patient Reported Outcome Measure (PROM) questionnaires.
  4. Fully understands study requirements and able to return for all required follow-up visits and assessments.
  5. Able to comply with all post-operative physician prescribed rehabilitation instructions.
  6. Index shoulder rotator cuff tendon tear surgical access may be performed using mini-open, single-portal arthroscopic or multi-portal arthroscopic intervention
  7. Meets all intended use and indications for use defined within the Integrity Implant System IFUs as applied to rotator cuff tendon tears. These include:

Index shoulder rotator cuff tendon tear needs management and protection from injury

Index shoulder has no substantial loss of tendon tissue

Index shoulder rotator cuff tendon tear footprint allows approximation of soft tissue and fixation of the Integrity Implant to tendon tissue using an Integrity Tissue Tack

Index shoulder rotator cuff tendon tear footprint allows fixation of the Integrity Implant to bone using the Integrity Bone Staple

Exclusion Criteria

The subject exclusion criteria are as follows:

  1. Medical condition that in the PI's opinion would place the subject at risk or interfere with the study
  2. Vulnerable population (prisoners, minors, pregnant women, mentally ill persons and the elderly or any person under any undue pressure from others to participate in the study)
  3. Pregnant, breastfeeding, or plans to become pregnant during the study
  4. History of poor compliance with medical treatment of any kind
  5. Deemed contraindicated for MRI by the PI
  6. Previous rotator cuff surgery (any type) on the index shoulder
  7. Current instability of the index shoulder
  8. Rotator cuff tendon tear is a Massive Cofield Classified Full-Thickness Tear (tear length >5cm)
  9. Chondromalacia of index shoulder ≥ Grade 3
  10. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3
  11. Insulin dependent Type I Diabetes
  12. History of heavy smoking (≥ 1 pack per day) within last 6-months
  13. History of auto-immune or immunodeficiency disorders
  14. Currently taking immunosuppression medication for other diseases (e.g., transplants or other inflammatory diseases)
  15. Oral steroid use in the last 2-months or injectable steroid use in the last 3-months
  16. History of cognitive or mental health status that interferes with study participation
  17. Poor comprehension of English language
  18. Meets one or more of the contraindications defined within the Integrity Implant System IFUs as applied to rotator cuff tendon tears. These include:

18.1 Rotator cuff tendon tear is deemed irreparable by the PI

18.2 Rotator cuff tendon tear repair requires replacement of damaged tendon

18.3 Rotator cuff tendon tear repair requires fixation of soft tissue to adjoining soft tissue

18.4 Rotator cuff tendon tear repair requires tendon strength reinforcement

18.5 Presence of infection

18.6 Any condition which would limit the ability or willingness to restrict activities or follow directions during the healing period

18.7 Hypersensitivity to any of the Integrity Implant System components

18.8 Inadequate soft tissue support for Integrity Tissue Tack fixation

18.9 Inadequate quality of bone for Integrity Bone Staple fixation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Integrity Implant System
Device: Integrity Implant System
Integrity Implant System used for Rotator Cuff Repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Re-tear rate after rotator cuff augmentation
Time Frame: 12 months postoperatively
Assessed by MRI evaluation at 12 months post-operatively defined using Sugaya classification system.
12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The American Shoulder and Elbow Surgeons (ASES) Score
Time Frame: Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month Post-operatively
The American Shoulder and Elbow Surgeon's (ASES) Score is a tool used to measure shoulder function. The ASES score is on a scale of 0 to 100, with 0 being the worst possible score and 100 the best. The score consists of two components - pain and activities of daily living.
Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month Post-operatively
Constant-Murley Score (CMS)
Time Frame: Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively
The Constant-Murley Shoulder Score is a scoring method used by clinicians to assess function of the shoulder. The standard score is on a scale of 0 to 100, with 0 being no shoulder function and 100 being excellent function.
Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively
EQ-5D-5L (EuroQol)
Time Frame: Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively
The 5-level EQ-5D (EQ-5D-5L) is a standardized self-assessed, health related quality of life questionnaire. It is composed of five questions with Likert scale response options (descriptive system) and a visual analog scale (EQ-VAS). The EQ-VAS asks patients to rate their own health from 0 to 100 (the worst and best imaginable health, respectively).
Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively
The Single Assessment Numeric Evaluation (SANE) Score
Time Frame: Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively
The Single Assessment Numeric Evaluation (SANE) Score is a tool used to assess the subject's perception of their affected joint. Participants are requested to rate their shoulder function on a scale of 0 to 100, with 0 as the worst option and 100 being normal shoulder function.
Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anika Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

December 15, 2024

First Submitted That Met QC Criteria

December 15, 2024

First Posted (Actual)

December 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 13, 2025

Last Update Submitted That Met QC Criteria

November 12, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol 24-01

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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