Rotator Cuff Tears of the ShoulderNCT06741527
Integrity Implant System Post Market Clinical Follow-Up Study
A study testing Integrity Implant System in people with Rotator Cuff Tears of the Shoulder, run by Anika Therapeutics, Inc. at 9 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tears of the Shoulder
- What is being tested?
- Integrity Implant System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Feb 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Central Indiana Orthopaedics
Fishers, Indiana, 46037
Brad Crackel, ATC, 317-773-4301, brad_crackel@ciocenter.com
Derek Yocum, PhD, 574-247-9441 ext. 5199, DYocum@sbortho.com
- Recruiting
Campbell Clinic
Germantown, Tennessee, 38138
Lucy Del Mar, MD, 901-759-5495, ldelmar@campbell-foundation.org
Margaret Knack, RN, 901-759-5413, mknack@campbell-foundation.org
- Recruiting
OrthoArizona
Gilbert, Arizona, 85234
Robert Wallace, 800-774-1534, r.wallace@prgresearch.com
Audrey Fierro, 800-774-1534 ext. 716, a.fierro@prgresearch.com
- Recruiting
Steadman Hawkins Clinic of the Carolinas
Greenville, South Carolina, 29615
Allison Nall, MS, 864-454-7458, Allison.nall@hawkinsfoundation.com
Allyson Sandago, 864-454-7458, Allyson.sandago@hawkinsfoundation.com
- Recruiting
Virtua Health
Marlton, New Jersey, 08053
Donna Hoopes, 856-355-1206 ext. 1206, Dhoopes@virtua.org
Kristin Broderick, 856-355-1225, Kbroderick@virtuahealth.org
- Recruiting
Premier Orthopaedic Trauma Specialists, PMC
Pomona, California, 91767
Joseph Liu, 909-596-4346, jliu@premierortho.org
Joseph N Liu, MD
- Recruiting
Harbin Clinic
Rome, Georgia, 30165
Terri Brannon, 762-235-2612, Terri.Brannon@advocatehealth.org
Brandon Bushnell, MD
- Recruiting
Foundation for Orthopaedic Research and Education
Tampa, Florida, 33607
Debbi Warren, RN, 844-944-4263, dwarren@foreonline.org
Peter Simon, PhD, 844-044-4263, psimon@foreonline.org
- Recruiting
Towson Orthopaedic Associates/University of Maryland St. Joseph's Medical Center
Towson, Maryland, 21204
Debbie Codd, 410-218-4499, debbie.codd@comcast.net
Timothy Codd, MD
About this study
Official title: 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).
Read the 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.
- Conditions
- Rotator Cuff Tears of the Shoulder
- Being tested
- Integrity Implant System
- Keywords
- Rotator Cuff Repair, Shoulder repair, Integrity Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrity Implant SystemDevice
Integrity Implant System used for Rotator Cuff Repair
| Study group | Role | What they receive |
|---|---|---|
| Integrity Implant System | Other | Not described Receives: Device: Integrity Implant System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-tear rate after rotator cuff augmentation
Assessed by MRI evaluation at 12 months post-operatively defined using Sugaya classification system.
Measured: 12 months postoperatively
Secondary outcomes (4)
The American Shoulder and Elbow Surgeons (ASES) Score
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.
Measured: Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month Post-operatively
Constant-Murley Score (CMS)
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.
Measured: Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively
EQ-5D-5L (EuroQol)
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).
Measured: Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively
The Single Assessment Numeric Evaluation (SANE) Score
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.
Measured: Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Feb 2025
- Primary completionJun 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Tears of the ShoulderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anika Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741527
- Sponsor's protocol ID
- Protocol 24-01
- Status last verified
- Jun 2026
- First submitted
- 15 Dec 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Confirmatory Interventional Clinical Study of the Integrity Implant System Used for Rotator Cuff Tear Augmentation
- ClinicalTrials.gov ID
- NCT06741527
- Acronym / sponsor ID
- Protocol 24-01
- Conditions
- Rotator Cuff Tears of the Shoulder
- Keywords
- Rotator Cuff Repair, Shoulder repair, Integrity Implant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Anika Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 19 Dec 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 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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrity Implant System | Other | Device: Integrity Implant System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (28 listed)
- 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
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 |
|---|---|---|
| Integrity Implant SystemIntegrity Implant System used for Rotator Cuff Repair | Device | Integrity Implant System |
Primary outcome
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.
4 secondary outcomes
The American Shoulder and Elbow Surgeons (ASES) Score
Time frame: 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
EQ-5D-5L (EuroQol)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrity Implant System in people with Rotator Cuff Tears of the Shoulder, run by Anika Therapeutics, Inc. at 9 sites 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 0 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kara Mezger (781-457-9000, kmezger@anika.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-tear rate after rotator cuff augmentation (time frame: 12 months postoperatively). 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 24 Jun 2026.