Bioinductive Implant for Rotator Cuff Tears

(IMPACT Trial)

Recruiting at 16 trial locations

Overseen By Alec Howard

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Smith & Nephew, Inc.

Must not be taking: Steroids

Disqualifiers: Osteoarthritis, Inflammatory arthropathy, Shoulder surgery, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

234 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used systemic steroids (like oral or IV steroids) or had a local steroid injection within 3 months before the surgery.

What data supports the effectiveness of the treatment REGENETEN Bioinductive Implant System for rotator cuff tears?

Research shows that the REGENETEN bioinductive implant can increase tendon thickness and improve functional outcomes in rotator cuff repairs, with long-term improvements in clinical scores and no serious adverse events reported. ^{1 2 3 4 5}

Is the REGENETEN Bioinductive Implant safe for humans?

The REGENETEN Bioinductive Implant has been used in rotator cuff repairs and has shown improvements in tendon thickness and function without any serious adverse events reported in studies. ^{1 2 3 4 6}

How is the REGENETEN Bioinductive Implant treatment different from other treatments for rotator cuff tears?

The REGENETEN Bioinductive Implant is unique because it uses a bio-inductive collagen implant to promote new tissue growth and increase tendon thickness, which helps improve healing in rotator cuff repairs. Unlike other treatments that may provide immediate structural support, this implant focuses on enhancing the body's natural healing process over time. ^{1 4 5 6 7}

Research Team

Laura Mills

Principal Investigator

Smith & Nephew, Inc.

Eligibility Criteria

This trial is for adults over 18 with high-grade partial-thickness rotator cuff tears who haven't improved after 3 months of non-surgical treatment. Candidates must be able to attend all study visits and complete questionnaires. Exclusions include prior shoulder surgery, full thickness tears, certain joint conditions, pregnancy, litigation or compensation claims related to the shoulder injury, drug/alcohol abuse, hypersensitivity to bovine materials, and inability to undergo MRI.

Inclusion Criteria

I am older than 18 years.

I can attend all required study visits.

The subject must provide written informed consent

Exclusion Criteria

Subjects who are enrolled, or plan to enroll, in another clinical trial during this study that would affect the outcomes of this study

I have a nerve condition affecting my arms.

Subject who, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, and drug or alcohol abuse

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo surgical treatment of partial-thickness rotator cuff tears using either the REGENETEN Bioinductive Implant system or the standard 'Completion and Repair' technique

Inter-operative time

Initial Recovery

Participants begin initial recovery and rehabilitation post-surgery, including shoulder immobilization and physical therapy

6 weeks

Regular physical therapy visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points

24 months

Follow-up visits at 3, 6, 12, and 24 months

Treatment Details

Interventions

• REGENETEN™ Bioinductive Implant System

Trial Overview The study compares the REGENETEN™ Bioinductive Implant with standard 'Completion and Repair' technique in treating partial-thickness rotator cuff tears. It aims to determine if patients can return faster to daily activities using the implant versus traditional repair methods.

Participant Groups

Group I: Isolated Bioinductive Repair Experimental Treatment 1 Intervention

Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.

Group II: Completion and Repair Active Control 1 Intervention

Surgical treatment of partial-thickness rotator cuff tears using the standard surgical technique 'Completion and Repair'.

REGENETEN™ Bioinductive Implant System is already approved in United States, European Union for the following indications:

Approved in United States as REGENETEN Bioinductive Implant for:

• Partial-thickness rotator cuff tears
• Full-thickness rotator cuff tears

Approved in European Union as REGENETEN Bioinductive Implant for:

• Partial-thickness rotator cuff tears
• Full-thickness rotator cuff tears

Who Is Running the Clinical Trial?

Smith & Nephew, Inc.

Lead Sponsor

Trials

176

Recruited

23,500+

Dr. Maria Berkman

Smith & Nephew, Inc.

Chief Medical Officer since 2023

MD from Harvard Medical School

Dr. Deepak Nath

Smith & Nephew, Inc.

Chief Executive Officer since 2022

PhD in Theoretical Mechanics, University of California, Berkeley

Findings from Research

The recurrence of rotator cuff tears after arthroscopic repair is often due to failure of tendon healing, which can be linked to poor tissue quality.

The use of a resorbable bio-inductive collagen implant (REGENETEN) has been shown to enhance tendon thickness during rotator cuff repair, potentially improving healing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tips and Tricks for Augmenting Rotator Cuff Repair With a Bio-inductive Collagen Implant. Pupa, L., Sheth, M., Goldenberg, N., et al.[2022]

The use of the collagen-based bioinductive implant REGENETEN alongside standard surgical repair of rotator cuff tears (RCTs) resulted in a significantly higher healing rate of 90.7% compared to 72.9% for surgery alone over a one-year period.

From a cost-effectiveness perspective, using REGENETEN led to savings of €4918 per healed tear when considering societal costs, while the incremental cost-effectiveness ratio from the NHS perspective was €17,857 per healed tear, indicating it is a valuable treatment option for RCT management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic Evaluation of a Bioinductive Implant for the Repair of Rotator Cuff Tears Compared with Standard Surgery in Italy. Rognoni, C., Nherera, LM., Garofalo, R., et al.[2023]

The Regeneten bioinductive collagen implant significantly improves functional outcomes and tendon thickness in patients with partial-thickness rotator cuff tears, without requiring formal tendon-bone reattachment, leading to a quicker rehabilitation process.

This procedure has shown to be safe, with no serious adverse events reported at 2 years postoperatively, making it a promising alternative to traditional surgical methods for managing partial-thickness rotator cuff tears.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isolated Bioinductive Arthroscopic Repair of Partial-Thickness Rotator Cuff Tears Using a Resorbable Collagen Implant. Thangarajah, T., Ling, FK., Lo, IK.[2022]

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]

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 64 patients with high-grade partial-thickness rotator cuff tears, those treated with a bioinductive collagen patch experienced significantly higher rates of postoperative stiffness and required more reoperations compared to those who did not receive the patch.

Specifically, 8 out of 32 patients in the patch group developed stiffness within the first 12 weeks, leading to 6 reoperations, while only 1 patient in the control group experienced stiffness, highlighting potential concerns about the use of the bioinductive patch in surgical repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased stiffness and reoperation rate in partial rotator cuff repairs treated with a bovine patch: a propensity-matched trial. Yeazell, S., Lutz, A., Bohon, H., et al.[2022]

In a study of 115 patients with full-thickness rotator cuff tears, the use of a bioinductive bovine collagen implant during repair resulted in a low retear rate of 16.5% at one year, which is favorable compared to existing literature.

Patients showed significant improvement in shoulder function, with 91.7% meeting the minimally clinically important difference in the American Shoulder and Elbow Surgeons (ASES) score at one year, indicating that the collagen implant may enhance recovery outcomes after rotator cuff repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retear rates and clinical outcomes at 1 year after repair of full-thickness rotator cuff tears augmented with a bioinductive collagen implant: a prospective multicenter study. Bushnell, BD., Connor, PM., Harris, HW., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Tips and Tricks for Augmenting Rotator Cuff Repair With a Bio-inductive Collagen Implant. [2022]

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

Economic Evaluation of a Bioinductive Implant for the Repair of Rotator Cuff Tears Compared with Standard Surgery in Italy. [2023]

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

Isolated Bioinductive Arthroscopic Repair of Partial-Thickness Rotator Cuff Tears Using a Resorbable Collagen Implant. [2022]

4. 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]

5. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Increased stiffness and reoperation rate in partial rotator cuff repairs treated with a bovine patch: a propensity-matched trial. [2022]

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

Retear rates and clinical outcomes at 1 year after repair of full-thickness rotator cuff tears augmented with a bioinductive collagen implant: a prospective multicenter study. [2022]