Treating Rotator Cuff Tears Using the Regenten Patch

Fotios P. Tjoumakaris, MD June 18th, 2021

A rotator cuff tear is a condition where the group of muscles and tendons that surround the shoulder joint – called the rotator cuff – is torn as the result of an injury. There are different methods of treatment based on the severity of the tear. A high grade tear, meaning more than 50% thickness of the rotator cuff, is to complete the tear, then perform a standard arthroscopic repair surgery.

Introducing the Regenten Patch

One of the challenges of this surgery is proper healing of the tendon to bone afterward. Sometimes healthy rotator cuff tendon is sacrificed in order to get an adequate repair of the whole tendon. More recently, a bio-inductive implant, called the Regeneten patch has been developed to assist with healing of partial thickness rotator cuff tears. 

Recent studies have demonstrated the effectiveness of this implant, which is composed of type 1 collagen. These studies, however, do not directly compare the patch with the more conventional/traditional technique. The Regeneten patch is used to supplement the rotator cuff tendon without compromising integrity, in the hope that healthy tendon will “regenerate” into the matrix of the patch and repair the damaged tissue.

Rothman Orthopaedic Institute Regenten Patch Study

A team at the Rothman Orthopaedic Institute, as part of a multi-center, multinational clinical trial is taking on the challenge of determining the best way of treating high grade partial thickness rotator cuff tears. This clinical trial will directly compare a group of patients that receive conventional treatment (take-down and repair surgery) with a group that receive the Regeneten patch procedure for high-grade partial thickness rotator cuff tears. This trial is actively recruiting at the Rothman Orthopaedic Institute.  

Some potential advantages of the patch include: less tissue trauma, no need to “sacrifice” healthy tendon, quicker rehabilitation, and less post-operative pain. The unknown portion of the study includes whether the patch treatment will result in a more durable repair, and improved post-operative outcomes and healing.  

Patients enrolled in the study will be followed for 2 years after their procedure and have post- operative visits in which routine questionnaires are administered to assess for functional outcomes. Additionally, patients will be sent for MRI’s at various timepoints to confirm healing of the rotator cuff. The trial will be funded by Smith and Nephew, the manufacturers of the Regeneten implant and hopes to answer a very important clinical question. The hope is that we can improve the lives of our patients with the results of this study.

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