Integrity Implant System for Rotator Cuff Tears

Recruiting at 6 trial locations

Overseen By Jennifer Williams

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Anika Therapeutics, Inc.

Must not be taking: Immunosuppressants, Oral steroids

Disqualifiers: Pregnancy, Type I diabetes, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of the Integrity Implant System, a medical device for individuals with rotator cuff tears. Researchers aim to confirm its performance, safety, and benefits for those needing additional support for their shoulder tendons, whether repaired or not. Individuals with a rotator cuff tear requiring management and protection, who have not undergone prior surgery, may qualify. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, allowing researchers to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking immunosuppression medication or have used oral steroids in the last 2 months or injectable steroids in the last 3 months.

What is the safety track record for the Integrity Implant System?

Research has shown that the Integrity Implant System is generally safe for treating rotator cuff tears. Studies have examined device-related problems, but no major safety issues have emerged. The FDA has approved the implant for treating tendon injuries, indicating its safety. Similar treatments, such as collagen implants, have also been well-tolerated. This is a Phase 4 study, meaning the implant has undergone extensive testing and is deemed safe for widespread use, though researchers continue to gather more information to confirm its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The Integrity Implant System is unique because it offers a new way to treat rotator cuff tears by focusing on structural support and tissue integration. Unlike current standard treatments like physical therapy, corticosteroid injections, or surgical repair, this implant system aims to enhance the body's natural healing process by providing a scaffold that supports tissue regrowth. Researchers are excited about this treatment because it could lead to quicker recovery times and more durable repair of the shoulder, potentially reducing the need for repeat surgeries.

What evidence suggests that the Integrity Implant System is effective for rotator cuff tears?

Research has shown that the Integrity Implant System effectively treats rotator cuff tears. One study found a structural failure rate of 15.9% for the implant, which is lower than the usual rates for similar tears treated with standard methods. This suggests the implant is a dependable option for repairing rotator cuff tears. Made from hyaluronic acid, the implant aids in repairing tendons, such as those in the shoulder. Although there is a 10.4% chance of serious complications, including the need for additional surgeries, the implant's overall effectiveness remains promising. This Phase 4 trial aims to confirm its efficacy and safety for patients. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with rotator cuff injuries or tears. Specific details about who can join are not provided, but typically participants should meet certain health standards and be experiencing the condition the study is targeting.

Inclusion Criteria

My shoulder surgery can be done with a small open cut or through a camera-guided procedure.

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

Exclusion Criteria

Poor comprehension of English language

I have a history of autoimmune or immunodeficiency disorders.

My shoulder has a large tear in the rotator cuff tendon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-Operative

Pre-operative assessments and preparation for surgery

1-2 weeks

1 visit (in-person)

Treatment

Surgical procedure for rotator cuff tear augmentation using the Integrity Implant System

1 day

1 visit (in-person)

Post-Operative Follow-up

Participants are monitored for safety and effectiveness, with assessments at 6 weeks, 6 months, 12 months, and 24 months post-operatively

24 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Integrity Implant System

Trial Overview

The Integrity Implant System, a device used to help heal rotator cuff injuries, is being tested. The study observes patients at multiple centers over time to confirm how well it works and its safety when used as an augmentation in repairs.

How Is the Trial Designed?

Group I: Integrity Implant System Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Anika Therapeutics, Inc.

Lead Sponsor

Trials

19

Recruited

3,100+

Published Research Related to This Trial

In a study involving 210 patients undergoing arthroscopic repair of full-thickness rotator cuff tears, the use of a resorbable bioinductive bovine collagen implant led to significant improvements in shoulder function and quality of life measures after one year, regardless of the size of the tear.

The study reported a 10.4% rate of serious complications, including revision surgeries and other issues, indicating that while the implant is effective, there are risks associated with the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Full-Thickness Rotator Cuff Tears Can Be Safely Treated With a Resorbable Bioinductive Bovine Collagen Implant: One-Year Results of a Prospective, Multicenter Registry. McIntyre, LF., McMillan, S., Trenhaile, SW., et al.[2022]

In a study of 22 patients with massive rotator cuff tears, only 41% achieved substantial clinical benefit from biologically enhanced patch augmentation repair, indicating that while some patients improved, many did not experience significant recovery.

The procedure showed a significant increase in shoulder function as measured by the Simple Shoulder Test, but pain score improvements were not statistically significant, suggesting that while the technique may enhance function, it may not effectively reduce pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes Following Biologically Enhanced Patch Augmentation Repair as a Salvage Procedure for Revision Massive Rotator Cuff Tears. Muench, LN., Kia, C., Jerliu, A., et al.[2020]

In a study involving 120 patients undergoing arthroscopic rotator cuff repair, the all-suture anchor demonstrated equivalent clinical performance to the established solid suture anchor, with no significant differences in Constant-Murley scores at the 12-month follow-up.

The retear rates for both anchors were similar, with 5.7% for the all-suture anchor and 1.9% for the solid anchor, indicating that the all-suture anchor is a safe and effective alternative for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An All-Suture Anchor Offers Equivalent Clinical Performance to an Established Solid Suture Anchor in the Arthroscopic Repair of Rotator Cuff Tears: A Prospective, Randomized, Multicenter Trial With 12-Month Follow-Up. Yan, H., Zhao, L., Wang, J., et al.[2023]

The BioBrace™ is a novel bio-inductive scaffold designed for rotator cuff augmentation, combining the benefits of tissue induction and structural strength, which addresses the limitations of existing treatments.

This innovative implant uses a unique composition of type I collagen and bio-resorbable microfilaments, aiming to enhance tissue incorporation while providing immediate support during the healing process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Rotator Cuff Repair Technique Using a Bio-Composite Scaffold for Tissue Augmentation. Cheesman, QT., Szukics, PF., Stark, M., et al.[2022]

In a study of 51 patients with massive, irreparable rotator cuff tears, subacromial balloon placement led to significant improvements in shoulder function, with total Constant-Murley scores increasing from 27 to 77 after an average follow-up of 36 months.

The procedure demonstrated high implant survival rates (87% at 3-4 years) and high patient satisfaction, with 98% of patients exceeding the minimal clinically important difference, indicating that this intervention is effective and well-tolerated for managing such injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subacromial Balloon Spacer for Massive, Irreparable Rotator Cuff Tears Is Associated With Improved Shoulder Function and High Patient Satisfaction. Familiari, F., Nayar, SK., Russo, R., et al.[2021]

The bioinductive collagen implant used for treating partial- and full-thickness rotator cuff tears demonstrated significant safety and efficacy, with patients showing marked improvements in pain and function at 1-year follow-up, as measured by various standardized outcomes.

In the study involving patients with rotator cuff tears, 84% of those with partial tears and 72% of those with full-thickness tears reported clinically meaningful improvements in pain and shoulder function, indicating the implant's effectiveness in promoting healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes After Use of a Bioabsorbable Collagen Implant to Treat Partial and Full-Thickness Rotator Cuff Tears. McIntyre, LF., Bishai, SK., Brown, PB., et al.[2020]

In a study of 1,661 arthroscopic rotator cuff repairs (ARCRs) over 6 months, 18.5% of patients experienced adverse events, with shoulder stiffness being the most common complication at 7.6%.

The risk of adverse events varied by the extent of the rotator cuff tear, with the highest risk (25.6%) observed in patients with three ruptured tendons, indicating that more severe tears may lead to higher complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications Within 6 Months After Arthroscopic Rotator Cuff Repair: Registry-Based Evaluation According to a Core Event Set and Severity Grading. Felsch, Q., Mai, V., Durchholz, H., et al.[2021]

In a retrospective study of 41 shoulders from 40 patients who underwent open surgical treatment for rotator cuff tears, 80% reported satisfactory outcomes after an average follow-up of 5 years.

Factors such as age, sex, activity level, and the size of the tear were identified as predictive parameters for the final satisfaction with the surgery, with younger and more active patients generally reporting lower satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Satisfactory results of surgical reconstruction of rotator cuff ruptures, 1984-1990]. Holtslag, HR., Jaspers, PJ., Marting, LN., et al.[2019]

The biodegradable sub-acromial spacer (InSpace™) implantation in 20 patients with massive irreparable rotator cuff tears showed significant improvement in shoulder function over 3 years, with the Constant score increasing from 33.4 to 65.4 points.

The procedure was found to be low-risk and simple, with sustained pain relief and functional improvements in daily activities and motion, indicating its efficacy as a treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears. Senekovic, V., Poberaj, B., Kovacic, L., et al.[2022]

In a study of 78 patients who underwent rotator cuff repair, significant functional improvements were observed post-surgery, with evaluations showing better pain relief and satisfaction after an average follow-up of 19.6 months.

Interestingly, the study found that functional outcomes did not correlate with the anatomical integrity of the cuff, indicating that factors like age and fatty degeneration of the infraspinatus muscle are more critical in predicting surgical success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic factors affecting anatomic outcome of rotator cuff repair and correlation with functional outcome. Oh, JH., Kim, SH., Ji, HM., et al.[2022]

In a study involving 40 rats, the use of P2 porous titanium-coated implants at the tendon-to-bone interface significantly improved mechanical properties of supraspinatus tendon repairs, showing increased maximum load and stress at 2 and 4 weeks post-surgery.

Histological analysis indicated that the P2 implants did not cause any foreign body reactions and promoted healthy bone growth, supporting their potential for enhancing tendon-to-bone healing in rotator cuff repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

P2 porous titanium implants improve tendon healing in an acute rat supraspinatus repair model. Tucker, JJ., Gordon, JA., Zanes, RC., et al.[2018]

In a study of 52 patients with medium to large rotator cuff tears, the arthroscopic repair technique using triple-loaded anchors and bone marrow vents achieved a 91% healing rate as confirmed by MRI.

Patients with healed repairs reported significantly better clinical outcomes, with a median Western Ontario Rotator Cuff (WORC) score of 96.7, compared to a score of 64.6 for those with re-tears, highlighting the importance of successful repair for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Excellent healing rates and patient satisfaction after arthroscopic repair of medium to large rotator cuff tears with a single-row technique augmented with bone marrow vents. Dierckman, BD., Ni, JJ., Karzel, RP., et al.[2018]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06353893

MRI Evaluation of Integrity Implant for Rotator Cuff Tears

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 ...

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withpower.com

withpower.com/trial/phase-4-rotator-cuff-injuries-11-2024-8510b

Integrity Implant System for Rotator Cuff Tears

The study reported a 10.4% rate of serious complications, including revision surgeries and other issues, indicating that while the implant is effective, there ...

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anika.com

anika.com/medical/products/integrity/

Integrity

The Integrity Implant is a hyaluronic acid-based scaffold intended for rotator cuff repair, Achilles repair, and other tendon repair applications.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9284254/

Clinical outcomes and structural integrity rate of ...

Observed structural failure rate of 15.9% is lower than those reported in the literature for standard rotator cuff repair of medium to massive tears in similar ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2666638320302061

Retear rates and clinical outcomes at 1 year after repair of ...

The purpose of this study was to evaluate healing rates and clinical outcomes of full-thickness rotator cuff repairs augmented with a bioinductive bovine ...

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anika.com

anika.com/patients/resources/integrity-clinical-trial/

Integrity Clinical Study

The study's objective is to confirm the performance, safety and clinical benefit of the Integrity Implant System when used for rotator cuff tear augmentation.

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accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf22/K223538.pdf

August 17, 2023 Anika Therapeutics, Inc. Wei Zhao Executive ...

The Integrity Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2212628725005596

Hyaluronic Acid−Biocompatible Implant System for Rotator ...

This Technical Note aims to describe a surgical technique using a hyaluronic acid−based biocompatible implant for both partial- and full- ...