Integrity Implant System for Rotator Cuff Tears

Recruiting at 6 trial locations

Overseen By Supraja Kotharu

Age: 18+

Sex: Any

Trial Phase: Phase 4

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)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the Integrity Implant System treatment for rotator cuff tears?

The research on similar treatments, like the use of a bioabsorbable collagen implant, shows improved healing and safety in rotator cuff tears, suggesting that the Integrity Implant System might also be effective in enhancing shoulder function and patient satisfaction. ^{1 2 3 4 5}

Is the Integrity Implant System safe for humans?

Research on similar treatments, like bioinductive collagen implants and all-suture anchors, shows they are generally safe for treating rotator cuff tears, with studies reporting no major safety concerns. ^{3 6 7 8 9}

How does the Integrity Implant System treatment for rotator cuff tears differ from other treatments?

The Integrity Implant System is unique because it likely uses a porous titanium material that promotes better integration with bone and soft tissue, enhancing the structural integrity of the repair. This differs from other treatments that may focus on bio-inductive properties or immediate structural strength without promoting long-term tissue integration. ^{3 7 10 11 12}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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 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 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 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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Subacromial Balloon Spacer for Massive, Irreparable Rotator Cuff Tears Is Associated With Improved Shoulder Function and High Patient Satisfaction. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical Outcomes Following Biologically Enhanced Patch Augmentation Repair as a Salvage Procedure for Revision Massive Rotator Cuff Tears. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes After Use of a Bioabsorbable Collagen Implant to Treat Partial and Full-Thickness Rotator Cuff Tears. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

[Satisfactory results of surgical reconstruction of rotator cuff ruptures, 1984-1990]. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Prognostic factors affecting anatomic outcome of rotator cuff repair and correlation with functional outcome. [2022]

6. United States 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. [2023]

7. France pubmed.ncbi.nlm.nih.gov

Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears. [2022]

8. United States 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. [2021]

9. United States 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. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

P2 porous titanium implants improve tendon healing in an acute rat supraspinatus repair model. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Arthroscopic Rotator Cuff Repair Technique Using a Bio-Composite Scaffold for Tissue Augmentation. [2022]

12. Germany 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. [2018]