Rotator Cuff TearsNCT06353893
MRI Evaluation of Integrity Implant for Rotator Cuff Tears
An observational study of Rotator Cuff Tears, run by Foundation for Orthopaedic Research and Education at 1 site in United States.
Trial summary
The goal of this observational study is to evaluate the effectiveness and safety of the Integrity bio-inductive implant in treating partial and full thickness rotator cuff tears. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Anika Integrity Implant System
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 1 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects will be recruited from patients with a history of rotator cuff repair surgery one to 83 days (about 2 and a half months) before the screening.
Who may be able to join
- Rotator cuff tear (both partial and full thickness) treated with Integrity bio-inductive implant augmentation to the superior surface of partial rotator cuff tears or the superior aspect of rotator cuff repairs (both single or double row);
- Subject can read and understand the ICF and has voluntarily provided written informed consent.
Who cannot join
- Conditions which, in the opinion of the Principal Investigator, may limit the subject's ability or willingness to follow post- operative care or study instructions;
- If patient is pregnant;
- Subject conditions which may hinder the healing process;
- Subject is a prisoner or member of another vulnerable population.
Trial locations and contacts
1 site in 1 country.
United States1 site
Foundation for Orthopaedic Research and Education
Tampa, Florida, 33607
About this study
Official title: Postoperative MRI Evaluation of the Integrity Bio-inductive Implant Augmentation of Rotator Cuff Tears of the Shoulder
The goal of this observational study is to evaluate the effectiveness and safety of the Integrity bio-inductive implant in treating partial and full thickness rotator cuff tears. The main questions it aims to answer are:
- How does the application of the Integrity implant affect patient-reported outcome measures (PROMs) such as ASES, SANE, and PROMIS?
- What are the imaging characteristics of the rotator cuff tears at 3 and 6 months postoperatively when using the Integrity implant?
Postoperative MRIs will be obtained from 10 consecutive patients who have undergone rotator cuff repair using the Integrity implant at 3 and 6 months after surgery. Participants include those with partial and full thickness tears treated with different surgical techniques involving the implant. They may receive either isolated onlay use of the graft for partial tears or augmentation of a standard single or double row repair with the graft applied to the superior surface of the repair.
Read the detailed description
The aim of this prospective, non-randomized, open-label, single-arm study is to evaluate the safety and effectiveness of the newly FDA-cleared Integrity graft for various types of rotator cuff repairs. This study incorporates preoperative assessments as well as follow-up assessments at 3 months and 6 months postoperatively. The primary objective is to document the safety profile of the Integrity graft by monitoring device-related adverse events throughout the study duration. Additionally, the study aims to assess the post-market effectiveness of the Integrity implant using patient-reported outcome measures and establish normal or standard findings on MRI to aid surgeons in clinical decision-making.
- Conditions
- Rotator Cuff Tears
- Being tested
- Anika Integrity Implant System
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anika Integrity Implant SystemDevice
The implant is a porous, flexible construct knitted using HYAFF® fibers and designed to support cell infiltration and regenerative healing. HYAFF is Anika's proven and proprietary esterified HA technology that resorbs over time as tissue remodels. Integrity is inherently strong and can be confidently manipulated arthroscopically, which offers a truly unique and differentiated solution for shoulder surgeons to treat rotator cuff tears.
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI Assessment of Adverse Events and Structural Integrity
The primary endpoint of this study is the adverse events rate and structural failure rate of the rotator cuff repair, determined by MRI, at 3 months and 6 months following use of the Anika Integrity implant system.
Measured: 3 and 6 months after index procedure
Secondary outcomes (6)
Effectiveness Evaluation with PROMIS outcome tool
The secondary endpoints of the study include evaluating PROMIS scores (assessing various aspects of quality of life in a questionnaire which is scored)
Measured: 3 months after index procedure
Effectiveness Evaluation with PROMIS tool
The secondary endpoints of the study include evaluating PROMIS scores (assessing various aspects of quality of life)
Measured: 6 months after index procedure
Effectiveness Evaluation with SANE score
The secondary endpoints of the study include evaluating SANE scores: Single assessment numeric rating scale of 0-10 with 0 being NO pain and 10 being worst or severe pain (patients' perceived improvement)
Measured: 3 months after index procedure
Effectiveness Evaluation with SANE score
The secondary endpoints of the study include evaluating SANE scores: Single assessment numeric rating scale of 0-10 with 0 being NO pain and 10 being worst or severe pain (patients' perceived improvement)
Measured: 6 months after index procedure
Effectiveness Evaluation with ASES rating scale
The secondary endpoints of the study include evaluating ASES rating scale (for shoulder function and pain) ASES is a mixed-outcome reporting tool, meaning it consists of a physician-rated and patient-rated questionnaire. The patient-rated questionnaire focuses on joint pain, instability and activities of daily living.
Measured: 3 months after index procedure
Effectiveness Evaluation with ASES rating scale
The secondary endpoints of the study include evaluating ASES rating scale (for shoulder function and pain)ASES is a mixed-outcome reporting tool, meaning it consists of a physician-rated and patient-rated questionnaire. The patient-rated questionnaire focuses on joint pain, instability and activities of daily living.
Measured: 6 months after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Apr 2024
- Primary completion23 Feb 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Orthopaedic Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Anika Therapeutics, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353893
- Sponsor's protocol ID
- Integrity-001
- Status last verified
- Sep 2026
- First submitted
- 13 Mar 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative MRI Evaluation of the Integrity Bio-inductive Implant Augmentation of Rotator Cuff Tears of the Shoulder
- ClinicalTrials.gov ID
- NCT06353893
- Acronym / sponsor ID
- Integrity-001
- Conditions
- Rotator Cuff Tears
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Foundation for Orthopaedic Research and EducationUniversity, hospital or other
- Collaborators
- Anika Therapeutics, Inc.
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to evaluate the effectiveness and safety of the Integrity bio-inductive implant in treating partial and full thickness rotator cuff tears. The main questions it aims to answer are:
- How does the application of the Integrity implant affect patient-reported outcome measures (PROMs) such as ASES, SANE, and PROMIS?
- What are the imaging characteristics of the rotator cuff tears at 3 and 6 months postoperatively when using the Integrity implant?
Postoperative MRIs will be obtained from 10 consecutive patients who have undergone rotator cuff repair using the Integrity implant at 3 and 6 months after surgery. Participants include those with partial and full thickness tears treated with different surgical techniques involving the implant. They may receive either isolated onlay use of the graft for partial tears or augmentation of a standard single or double row repair with the graft applied to the superior surface of the repair.
Detailed description
The aim of this prospective, non-randomized, open-label, single-arm study is to evaluate the safety and effectiveness of the newly FDA-cleared Integrity graft for various types of rotator cuff repairs. This study incorporates preoperative assessments as well as follow-up assessments at 3 months and 6 months postoperatively. The primary objective is to document the safety profile of the Integrity graft by monitoring device-related adverse events throughout the study duration. Additionally, the study aims to assess the post-market effectiveness of the Integrity implant using patient-reported outcome measures and establish normal or standard findings on MRI to aid surgeons in clinical decision-making.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be recruited from patients with a history of rotator cuff repair surgery one to 83 days (about 2 and a half months) before the screening.
Key inclusion criteria (2 listed)
- Rotator cuff tear (both partial and full thickness) treated with Integrity bio-inductive implant augmentation to the superior surface of partial rotator cuff tears or the superior aspect of rotator cuff repairs (both single or double row);
- Subject can read and understand the ICF and has voluntarily provided written informed consent.
Key exclusion criteria (4 listed)
- Conditions which, in the opinion of the Principal Investigator, may limit the subject's ability or willingness to follow post- operative care or study instructions;
- If patient is pregnant;
- Subject conditions which may hinder the healing process;
- Subject is a prisoner or member of another vulnerable population.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anika Integrity Implant SystemThe implant is a porous, flexible construct knitted using HYAFF® fibers and designed to support cell infiltration and regenerative healing. HYAFF is Anika's proven and proprietary esterified HA technology that resorbs over time as tissue remodels. Integrity is inherently strong and can be confidently manipulated arthroscopically, which offers a truly unique and differentiated solution for shoulder surgeons to treat rotator cuff tears. | Device | – |
Primary outcome
MRI Assessment of Adverse Events and Structural Integrity
Time frame: 3 and 6 months after index procedure
The primary endpoint of this study is the adverse events rate and structural failure rate of the rotator cuff repair, determined by MRI, at 3 months and 6 months following use of the Anika Integrity implant system.
6 secondary outcomes
Effectiveness Evaluation with PROMIS outcome tool
Time frame: 3 months after index procedure
Effectiveness Evaluation with PROMIS tool
Time frame: 6 months after index procedure
Effectiveness Evaluation with SANE score
Time frame: 3 months after index procedure
Effectiveness Evaluation with SANE score
Time frame: 6 months after index procedure
Effectiveness Evaluation with ASES rating scale
Time frame: 3 months after index procedure
Effectiveness Evaluation with ASES rating scale
Time frame: 6 months after index procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tears, run by Foundation for Orthopaedic Research and Education at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI Assessment of Adverse Events and Structural Integrity (time frame: 3 and 6 months after index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.