Rotium: Rotator Cuff Healing Using a Nanofiber Scaffold in Patients Greater Than 55 Years

Last updated: May 18, 2022
Sponsor: N/A
Overall Status: Active - Recruiting







Clinical Study ID

  • Ages 55-100
  • All Genders

Study Summary

Randomized controlled trial of patients over the age of 55 treated with and without a nanofiber scaffold during rotator cuff repair.

Eligibility Criteria


Inclusion Criteria:

  • Age 55 and older
  • Able to provide informed consent
  • Primary diagnosis of rotator cuff tear


Exclusion Criteria:

  • Revision rotator cuff surgery
  • Partial thickness rotator cuff tears
  • Massive (greater than 5cm) rotator cuff tears
  • Patients with current tobacco history

Study Design

Study Start date:
Estimated Completion Date:

Study Description

Despite numerous advancements in surgical techniques and over 250,000 procedures currently performed annually in the United States, failure of tendon healing following rotator cuff surgery occurs frequently with reports as high as 94%. Nonhealing can lead to persistent pain, poor outcomes, and a significant economic burden to society when revision surgery is required. Several factors have been associated with poor tendon healing with age greater than 60 years shown to be a significant risk factor due to diminishing vascularity at the bone tendon interface where the tear typically originates. While numerous techniques have been devised to improve fixation over the past several decades, very few have been developed to address or enhance the biology at the repair site. Rotium nanofiber is a recent FDA approved scaffold (FDA 510(K) #K183236) that has been shown to improve tendon healing to bone in animal studies. It works to mimic the extracellular matrix and helps concentrates and bind cells at the repair site providing a better organizational structure of the healing tissue. The purpose of the current study is to assess if use of the scaffold significantly improves rotator cuff healing and enhances strength in patients at higher risk of perioperative failure of the repair.

Connect with a study center

  • Baptist Healthcare System

    Lexington, Kentucky 40503
    United States

    Active - Recruiting

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