NCT06741527

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Feb 2025Oct 2027

First Submitted

Initial submission to the registry

December 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

November 13, 2025

Status Verified

November 1, 2025

Enrollment Period

2.3 years

First QC Date

December 15, 2024

Last Update Submit

November 12, 2025

Conditions

Rotator Cuff Tears of the Shoulder

Keywords

Rotator Cuff RepairShoulder repairIntegrity Implant

Outcome Measures

Primary Outcomes (1)

  • Re-tear rate after rotator cuff augmentation

    Assessed by MRI evaluation at 12 months post-operatively defined using Sugaya classification system.

    12 months postoperatively

Secondary Outcomes (4)

  • The American Shoulder and Elbow Surgeons (ASES) Score

    Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month Post-operatively

  • Constant-Murley Score (CMS)

    Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively

  • EQ-5D-5L (EuroQol)

    Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively

  • The Single Assessment Numeric Evaluation (SANE) Score

    Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively

Study Arms (1)

Integrity Implant System

OTHER
Device: Integrity Implant System

Interventions

Integrity Implant SystemDEVICE

Integrity Implant System used for Rotator Cuff Repair

Integrity Implant System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Medical condition that in the PI's opinion would place the subject at risk or interfere with the study
  • 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)
  • Pregnant, breastfeeding, or plans to become pregnant during the study
  • History of poor compliance with medical treatment of any kind
  • Deemed contraindicated for MRI by the PI
  • Previous rotator cuff surgery (any type) on the index shoulder
  • Current instability of the index shoulder
  • Rotator cuff tendon tear is a Massive Cofield Classified Full-Thickness Tear (tear length \>5cm)
  • Chondromalacia of index shoulder ≥ Grade 3
  • Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3
  • Insulin dependent Type I Diabetes
  • History of heavy smoking (≥ 1 pack per day) within last 6-months
  • History of auto-immune or immunodeficiency disorders
  • Currently taking immunosuppression medication for other diseases (e.g., transplants or other inflammatory diseases)
  • Oral steroid use in the last 2-months or injectable steroid use in the last 3-months
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Foundation for Orthopaedic Research and Education

Tampa, Florida, 33607, United States

RECRUITING

Central Indiana Orthopaedics

Fishers, Indiana, 46037, United States

RECRUITING

Towson Orthopaedic Associates/University of Maryland St. Joseph's Medical Center

Towson, Maryland, 21204, United States

RECRUITING

Virtua Health

Marlton, New Jersey, 08053, United States

RECRUITING

Steadman Hawkins Clinic of the Carolinas

Greenville, South Carolina, 29615, United States

RECRUITING

Campbell Clinic

Germantown, Tennessee, 38138, United States

RECRUITING

Central Study Contacts

Kara Mezger

CONTACT

7657710026kmezger@anika.com

Jennifer Williams

CONTACT

781-457-9000jlwilliams@anika.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2024

First Posted

December 19, 2024

Study Start

February 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

November 13, 2025

Record last verified: 2025-11

Locations

US(6)