FiberLocker® System for Rotator Cuff Tears

This trial tests a new method called the FiberLocker® System to aid in healing rotator cuff tears, which are painful shoulder injuries. Researchers aim to determine if this system enhances healing, function, and safety after surgery. Participants will undergo an MRI at least six months post-surgery to assess shoulder healing. Individuals planning surgery for a significant rotator cuff tear (at least 2 cm) and who have had an MRI within the last year may qualify for this study.

As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance future treatment options.

The trial information does not specify whether you need to stop taking your current medications. However, if you have had a corticosteroid injection in the operative shoulder within three months before surgery, you would be excluded from the trial.

Research shows that safety information for the FiberLocker® System, used in rotator cuff repairs, is collected from surgery through a 12-month follow-up. This system employs a special patch to aid in the repair. Studies have examined the frequency and types of side effects during this period.

MRI scans have confirmed improved healing in previous patients using this system. These scans, conducted at least six months post-surgery, assess the repair's durability. Although specific side effect numbers aren't available, ongoing testing suggests it is reasonably safe so far.

The FiberLocker® System is unique because it augments traditional rotator cuff repair, potentially enhancing the strength and durability of the repair. While standard treatments for rotator cuff tears typically involve sutures or anchors to reattach the tendon to the bone, the FiberLocker® System adds an extra layer of support. This system could improve healing outcomes and reduce the likelihood of re-tears, offering a promising option for patients with this common shoulder injury. Researchers are excited because it might lead to faster recovery times and better long-term results compared to existing methods.

Research has shown that the FiberLocker® System, used in rotator cuff repairs, can enhance healing. Studies suggest that this system offers a promising approach for managing difficult rotator cuff tears, which often heal poorly. Early results indicate that the system can reduce the risk of re-tearing and improve tendon healing, as observed in MRI scans at least six months post-surgery. In this trial, all participants will have their rotator cuff tears repaired with augmentation using the FiberLocker® System. This treatment aims to support the repaired tendon, potentially improving movement and increasing patient satisfaction.¹²³⁵⁶