NCT06741527 · Anika Therapeutics, Inc.
Integrity Implant System Post Market Clinical Follow-Up Study
What this study is about
The study design is a forward-looking, multi-center, single-treatment group$1, non-randomly assigned 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).
View original scientific description
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).
Interventions
DEVICE
Integrity Implant System
Integrity Implant System used for Rotator Cuff Repair
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- At least 18 years of age
- 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.
- Able to complete all Patient Reported Outcome Measure (PROM) questionnaires.
- Fully understands study requirements and able to return for all required follow-up visits and assessments.
- Able to comply with all post-operative physician prescribed rehabilitation instructions.
- Index shoulder rotator cuff tendon tear surgical access may be performed using mini-open, single-portal arthroscopic or multi-portal arthroscopic intervention
- 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:
- 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
- History of cognitive or mental health status that interferes with study participation
- Poor comprehension of English language
- 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
Exclusion criteria
- The subject exclusion criteria are as follows:
- 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
- History of cognitive or mental health status that interferes with study participation
- Poor comprehension of English language
- 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
Where
- Gilbert, Arizona
- Pomona, California
- Tampa, Florida
- Rome, Georgia
- Fishers, Indiana
- Towson, Maryland
- Marlton, New Jersey
- Greenville, South Carolina
- Germantown, Tennessee
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 24, 2026 · Source of record for eligibility and locations