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

  • STATUS
    Recruiting
Updated on 18 May 2022

Summary

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

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.

Details
Condition Orthopedics
Clinical Study IdentifierTX299751
Last Modified on18 May 2022

Eligibility

Yes No Not Sure

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
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