INTRODUCTION
This document is a protocol for a human research study. This study is to be
conducted according to United States standards of Good Clinical Practice in
accordance with applicable Federal regulations and institutional research policies
and procedures.
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.
BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE
Rotator cuff tears are a frequent cause of shoulder pain and disability in the
elderly population. Typically, when conservative measures fail, surgery is often
advised. A successful clinical outcome is felt to be heavily predicated on healing
of the tendon to the bone. Despite numerous surgical and technical advancements over
the past two decades not all repairs heal, with re-tear, or failure-to-heal,
remaining the number one complication associated with rotator cuff surgery. This in
turn creates a hefty economic burden on society whereupon surgeries are being
performed with poor eventual outcomes and ultimately wasted resources.
While reasons for failure are multifactorial, a strong correlation has been
associated with advancing age. In an observational study on the natural history of
rotator cuff disease, patients younger than 50 years old rarely had rotator cuff
tears whereas those greater than 60 had a statistically significant greater
incidence of unilateral and bilateral tears. Advancing age is believed to alter and
change the intrinsic properties of the tendon leading to stiffness, hypovascularity
and overall impairment of the biology of tendon healing. Furthermore, when repairs
fail, they typically do so within the first four months of surgery. Means,
therefore, to enhance the zone of the repair by increasing the cellularity
immediately following surgery may improve the overall healing and lessen failures.
Recently, nanofiber scaffolds have demonstrated the ability to mimic the
extracellular matrix and help structure, organize, and proliferate cellular
material. They do so by working, in essence, like a sponge when incorporated into
the repair site, helping to bind, organize, and promote cell migration. This in
effect, creates a less haphazard arrangement and induces better organization of
healing tissue at the cellular level. Rotium, is an FDA-approved, nonwoven,
microfiber matrix composed of PLCL (poly L-lactide-co-caprolactone) and PGL
(polyglycolide) that is indicated for use in rotator cuff repair to enhance healing
at the bone tendon interface. The implant is inserted under the rotator cuff tendon
and placed on top of the greater tuberosity at the time of surgery and typically
positioned over a suture. In a recent animal study performed at Colorado State
University, a nearly 75% increased strength of repair was demonstrated at twelve
weeks in those tendons treated with the graft. This will be the first prospective
randomized clinical study in humans assessing for a difference in healing and
strength in a population of patients considered at high risk for postoperative
failure of the repair.