December 13, 2017
Morrisville, VT – Mansfield Orthopaedics is one of the clinical trial sites for the study of GelrinC by Regentis Biomaterial. Regentis Biomaterial is conducting a phase 3 FDA regulated clinical study to evaluate the safety and efficacy of an investigational cartilage implant, GelrinC, compared to the current standard of care, Microfacture.
This is a non-comparative study meaning that all eligible patients enrolled in the SAGE clinical study will receive GelrinC treatment. The pain and function results of patients treated with GelrinC will be compared to people who have previously undergone the standard of care, microfracture surgery.
What is GelrinC
GelrinC is formed from a synthetic material called PEG-DA and denatured protein called fibrinogen. These two materials have been used in other medical products to treat other conditions individually, but combined they represent a novel combination product offering for cartilage repair. In the body, GelrinC is absorbed over time and is replaced by new, functional tissue. GelrinC is approved for sales and marketing in the European community. It has been studied clinically in Europe in more than 50 patients and suggested that GelrinC can provide substantial improvement in pain and function.
Additional information on the study
Because this is an FDA regulated clinical trial, specific criteria must be followed to determine who is eligible for inclusion. A patient must meet all of these criteria to be included and only a surgeon participating as an investigator in the GelrinC study can determine whether a patient is eligible. If you are between the ages of 18 and 50 years old, are suffering from pain in one knee and can provide informed consent then you may be eligible for this study.
From a Regentis Biomaterials release
Regentis Biomaterials announced on November 28, 2017 the start of its phase 3 pivotal clinical trial of GelrinC for the treatment of focal knee cartilage defects with successful surgery on three patients in the U.S. and Denmark. The U.S. procedures were performed by Dr. Jason Scopp at the Peninsula Orthopaedic Clinic in Salisbury, Maryland and by Dr. Bryan Huber at Mansfield Orthopaedics at Copley Hospital in Morrisville, VT while the Denmark procedure was completed by Dr. Martin Lind in Aarhus University Hospital in Aarhus.
Cartilage repair is the largest unmet need in orthopaedic sports medicine today. Articular cartilage is the smooth, white tissue covering the ends of bones where they come together to form joints. Focal defects of the cartilage layer are extremely painful for patients and usually occur due to sudden trauma. Surgical intervention is often required because of the limited capacity for cartilage to repair itself. The current standard of care treatment is microfracture but this only provides short term relief and often requires surgical re-intervention.
About Mansfield Orthopaedics
The expert team at Mansfield Orthopaedics offers a compassionate and efficient system of care, providing comprehensive orthopaedic evaluation, treatment and rehabilitation with clinics in Morrisville and Waterbury Vermont. Mansfield Orthopaedics specializes in pain-relieving treatments, state-of-the art resurfacing procedures, minimally-invasive surgery, and highly advanced custom total joint replacement surgeries. Our orthopaedic surgeons are among the region’s leaders in expertise in joint replacement. Physicians include Nicholas Antell, MD (trauma and sports medicine); Brian Aros, MD (knee, hip, total joint replacement and sports medicine); Bryan Huber, MD (knee, hip, total joint replacement, and sports medicine); John C. Macy, MD (shoulder replacement/reconstruction); Joseph S. McLaughlin, MD (hand, wrist, and upper extremities); Bryan Monier, MD (foot and ankle); and Saul Trevino, MD (non-operative foot and ankle). www.copleyvt.org/orthopaedics.