An interventional study of Integrity Implant System in Rotator Cuff Tears of the Shoulder, sponsored by Anika Therapeutics, Inc.. Recruiting at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Anika Therapeutics, Inc. · Not applicable, Interventional, and Treatment
Among 168 studies in Rotator Cuff Injuries with a site in United States — 40 open to participants now, 50 under way, none of them phase 3. Rotator Cuff Injuries · United States.
Among the 168 studies in Rotator Cuff Injuries with a site in United States, this one is the 20th largest by planned enrollment of the 130 interventional ones, is one of 11 that started in 2025, is one of 86 with no phase, reaches primary completion later than 30 of the 49 other live ones, and was the 155th registered.
631 studies on the registry are indexed under Rotator Cuff Injuries; 156 are open to participants now.
This study's planned enrollment of 150 is above the median of 60 across 456 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →40 of the 168 studies in Rotator Cuff Injuries with a site in United States are open now, in 9 countries. Each count lists the studies.
Of the 100 Rotator Cuff Injuries studies recruiting now, 40 (40%) set no upper age limit and 41 (41%) stop at 75 or younger; 9 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →168 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 11 started in 2025.
Median enrollment 60 across the 130 interventional studies, 77 across the 38 observational. Of the 86 that completed or were terminated, 28 (33%) have results posted.
40 of 168 have an industry lead sponsor. The 10 most frequent:
Anika Therapeutics, Inc. is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
Anika Therapeutics, Inc. has 1 study filed under Rotator Cuff Injuries — fewer than ten, so there is no comparison to draw.
29 of the studies in Rotator Cuff Injuries with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06735170University of MinnesotaTuberoplasty Versus Balloon Spacer | 2026-11-26 |
| NCT07851233Rothman Institute OrthopaedicsPatient Education and Sling Use After Shoulder Surgery | 2026-11-30 |
| NCT06039345University of UtahShoulder RFA Pilot Study | 2026-12 |
| NCT05011331Rhode Island HospitalThe Effect of a Custom Pillow on Sleep Quality in Patients With Nonoperative Rotator Cuff Syndrome | 2026-12 |
| NCT06669741Texas Bone and JointClinical Outcomes Related to Arthroscopic Rotator Cuff Repair Recovery Using Incrediwear | 2026-12-01 |
Among the 168 studies in Rotator Cuff Injuries with a site in United States, from their registry updates:
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).
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.
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:
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 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Integrity Implant System
Integrity Implant System used for Rotator Cuff Repair
Re-tear rate after rotator cuff augmentation
Assessed by MRI evaluation at 12 months post-operatively defined using Sugaya classification system.
Time frame: 12 months postoperatively
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively
Started Feb 2025 (actual). Primary completion is estimated for Jun 2027, 28 months after the start.
Of 252 interventional studies with no phase under Rotator Cuff Injuries, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 28 months is above that.
How these figures are worked out, and which studies are left out of them.
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Anika Therapeutics, Inc.