Integrity Clinical Study

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Are you in need of Rotator Cuff Repair?

The Integrity^™ implant may be for you.

Now enrolling the Integrity Clinical Study!

What is Integrity?

The Integrity implant is a naturally derived hyaluronic acid-based scaffold for rotator cuff repair that is designed to support regenerative healing and thickening of your tendon for a strong recovery.

• Natural hyaluronic acid-based scaffold
• Strong scaffold that augments tendon repair¹
• Regenerative biology that supports tendon tissue regeneration¹

Consider enrolling in the 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 (with or without repair).

It is a prospective, multi-center, single-arm, non-randomized post market clinical follow-up study.

You may be eligible if you meet the following criteria:

• You have a rotator cuff tendon tear that needs management and protection from injury
• You do not have substantial loss of tendon tissue in the shoulder with the tendon tear
• You are able to complete study requirements, return for follow-up visits, and comply with all post-operative physician prescribed rehabilitation instructions

For more information, including a complete list of inclusion and exclusion criteria and participating sites that are currently enrolling, click here.

Why enroll in a clinical study?

• Participation contributes to medical research and may help others gain access to the healing benefits of Integrity
• Participation may lead to a better outcome for your own healing
• Please note, participation is voluntary
• Compensation will be provided for follow-up visits and questionnaire completion

Integrity is FDA cleared for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Talk to your doctor to find out whether you’re an appropriate candidate for the Integrity clinical study.