What side effects are associated with this type of intervention?

Common treatments for Cuff Tear Arthropathy that promote tissue regeneration and healing include the use of bioinductive implants and platelet-rich plasma (PRP) injections. Bioinductive implants are designed to enhance tissue regeneration and healing, and while specific side effects are not detailed, general risks may include infection, pain, and inflammation at the site of implantation. PRP injections, derived from autologous blood, are generally safe but can cause minor and transient side effects such as pain, bleeding, tenderness, swelling, and bruising at the injection site. Both treatments aim to improve tissue repair but carry typical risks associated with surgical and injection procedures.

What prior FDA approvals exist?

FDA-approved treatments for Cuff Tear Arthropathy that promote tissue regeneration and healing include the use of biologic scaffolds and platelet-rich plasma (PRP). Biologic scaffolds, such as those used in the Bioinductive Implant, are designed to support tissue regeneration by providing a framework for new tissue growth. PRP therapy, which involves injecting a concentration of a patient's own platelets to accelerate healing, has also been explored for its regenerative properties. These treatments aim to enhance the body's natural healing processes and improve the integrity of rotator cuff repairs.

What other types of research exist?

Promising novel alternatives to Bioinductive Implants for Cuff Tear Arthropathy patients in 2024 include Platelet-Rich Plasma (PRP) therapy and autologous blood injections. Both treatments have shown efficacy in promoting tissue regeneration and healing in tendon and muscle injuries, including rotator cuff tendinopathy. These therapies involve using the patient's own blood components to enhance the natural healing process and have been supported by various clinical trials.

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Bioinductive Patch

Bioinductive Patch for Rotator Cuff Tears

Phase 4

Recruiting

Led By Stephanie J Muh, MC

Research Sponsored by Henry Ford Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Indicated and scheduled for arthroscopic rotator cuff repair.

Full-thickness medium (1-3 cm), large (3-5 cm), and massive (>5 cm) rotator cuff tears involving the supraspinatus and/or infraspinatus tendons demonstrated on magnetic resonance or ultrasound imaging.

Must not have

Patient scheduled for open or mini-open rotator cuff repair

Prior surgery of affected shoulder (except diagnostic arthroscopy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years postoperative

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial compares standard rotator cuff surgery with and without a special patch that helps the tendon heal. It targets patients who haven't improved with other treatments. The patch is expected to improve healing by encouraging tendon regrowth.

Who is the study for?

This trial is for adults over 18 who have medium to massive full-thickness rotator cuff tears, confirmed by imaging, and haven't improved after at least 6 weeks of physical therapy. It's not for those with previous shoulder surgeries (other than diagnostic arthroscopy), active infections, planned open shoulder repairs, acute injuries, small or partial tears, subscapularis tendon involvement, or autoimmune conditions.

What is being tested?

The study compares two ways to fix a torn rotator cuff in the shoulder: standard arthroscopic repair versus the same procedure plus a Bioinductive Implant. The main goal is to see if the implant helps maintain the repair after one year using ultrasound checks.

What are the potential side effects?

Possible side effects include discomfort from surgery and risks associated with implants such as inflammation or reaction at the implant site. Ultrasound used for imaging is generally safe but may cause mild discomfort during use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a shoulder surgery to repair the rotator cuff.

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I have a medium to massive tear in my shoulder's rotator cuff, confirmed by imaging.

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I have long-term shoulder tendon tears.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am scheduled for a specific shoulder surgery.

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I have had surgery on my shoulder before, but only for diagnosis.

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I have a partial tear in my shoulder's rotator cuff.

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I have a small tear in my shoulder tendon.

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I have a tear in my shoulder's subscapularis tendon.

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I have a recent and sudden shoulder injury.

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I currently have an infection.

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I have an autoimmune or rheumatologic disorder like rheumatoid arthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years postoperative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years postoperative

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years postoperative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rotator cuff repair integrity

Secondary study objectives

Complications

PROMs scores for depression

PROMs scores for upper extremity function

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Study GroupExperimental Treatment3 Interventions

Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year.

Group II: Control GroupActive Control2 Interventions

Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

arthroscopic rotator cuff repair

2016

N/A

~60

Bioinductive implant

2016

N/A

~640

Ultrasound Imaging

2018

Completed Phase 4

~760

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Cuff Tear Arthropathy include surgical interventions such as arthroscopic rotator cuff repair, often augmented with bioinductive implants, and non-surgical options like physical therapy and injections of platelet-rich plasma (PRP). Bioinductive implants promote tissue regeneration and healing by providing a scaffold that encourages the growth of new tendon-like tissue, which can improve the integrity of the rotator cuff repair. PRP injections work by delivering a high concentration of growth factors that accelerate tissue repair and reduce inflammation. These mechanisms are crucial for Cuff Tear Arthropathy patients as they aim to restore shoulder function, reduce pain, and prevent further degeneration of the shoulder joint.