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Clinical Research

Our physicians strive to continuously improve the diagnosis and treatment of musculoskeletal injuries and disorders. They stay updated on the latest developments and findings in academic medicine and conduct clinical research to inform best practices. Embracing research and collaboration is fundamental to our philosophy of care. *

GelrinC Trial Overview

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 GelrinCGelrinC 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. Bryan Huber, MD at Mansfield Orthopaedics is the Principal Investigator assisted by Leah Morse, PA-C.  Learn more at gelrinc.com.

Preventing Intraoperative Blood Loss

Tranexamic acid, TXA, is a synthetic analog of the amino acid lysine. It is used to prevent excess blood lost during surgery. At Copley Hospital, we evaluated 20 patients who received TXA prior to knee replacement surgery and 27 patients who did not receive TXA. We found that TXA had a significant benefit in blood loss. When TXA was used there was a 17.31 and 12.00% improvement with the hemoglobin and hematocrit, the percentage of red blood cells in the patient’s blood. No blood transfusions were required for the 20 patients who received TXA. We have also seen significant decrease in knee swelling and dressing changes in patients receiving TXA. The decrease in knee swelling has significant impact on function and flexion (bending) gains postoperatively. This data supports TXA being routinely used in joint replacement surgery and is consistent with current literature.

Analyzing Outcomes of Bicompartmental Knee Replacement Device

We looked at the ConforMis iDuo G2 knee replacement, a bicompartmental device composed of Femorotibial and Patellar components. [Note: a partial knee replacement is surgery to replace one or two parts of the knee. The Femorotibial refers to the weight bearing joint between the tibia and femur; the Patellar is the kneecap.] Twelve patients who underwent iDuo knee replacement by Dr. Bryan Huber were evaluated.

Normal range of motion at the knee is considered to be 0 degrees of extension (completely straight knee joint) to 135 degrees of flexion (fully bent knee joint). One year after surgery, the average knee flexion was 130 degrees. None of the 12 patients required a blood transfusion. Six weeks after surgery, 81% of patients said their knee felt “sometimes” or “always” normal. At 12 weeks after surgery, 100% of patients said their knee felt “sometimes” or “always” normal. At 12 weeks after surgery, 55% of patients reported no pain. This study showed that patients with a customized bicompartment knee replacement can excel postoperatively.

New Technology Tested to Treat Broken Shoulder (proximal humeral fracture, or PH fracture)

A majority of proximal humeral fractures are preferably treated conservatively. However, surgical management may be beneficial in fractures with significant displacement. Current surgical procedures have complication rates that can be unacceptably high. A new technology, termed the PH Cage, addresses the technical limitations associated with current available technologies. In December 2016, Dr. Macy presented his first experience with the PH Cage for the fixation of a PH fracture, which had previously failed conservative management.

The case presented involved a 70-year-old, right hand dominant, otherwise healthy and active, female presented to our clinic three months after falling onto her left shoulder. Initial treatment was non-operative; sling immobilization and limited physical therapy. She complained of persistent lateral shoulder pain and limited function in her left arm. Using a shared-decision making process, she elected to proceed with surgical management using the PH Cage. There were no intra-operative or post-operative complications. Her most recent follow-up x-rays obtained at 6 month post-op revealed a well-healed fracture with anatomical alignment and no hardware complications or avascular necrosis. The patient exhibited excellent range of motion, strength and function. She had no significant pain at last follow up. This is a retrospective case review of one difficult proximal humerus fracture malunion that went on to anatomic healing and an excellent patient-reported outcome. Dr. Macy is currently performing a prospective study evaluating the radiographic and clinical outcome of the PH Cage technology in comparison to existing technologies for the treatment of broken shoulders.

Analyzing Outcomes of Tri-Compartment Custom Knee Replacement Device

Patient specific customized total knee arthroplasty implants are now available as an alternative to off-the-shelf implants. A goal of this technology is to provide superior clinical outcomes while reducing complications. The ConforMis iTotal CR is a tri-compartment custom knee replacement constructed of cobalt chrome and is designed to conform to the surface of the patient’s femoral condyle (inside of the knee) and proximal tibia (shinbone).
Sixty-seven (67) patients who underwent ConfroMIS iTotal CR knee replacement by Dr. Bryan Huber were evaluated. One year after surgery, 60% of patients said their knee “always” felt normal. Normal range of motion at the knee is considered to be 0 degrees of extension (completely straight knee joint) to 135 degrees of flexion (fully bent knee joint). The average knee flexion was 117 degrees at six weeks after surgery and 125 degrees. Patients reported no pain with walking or climbing stairs one year after surgery. None of these patients required a blood transfusion.
Results from this study support previous findings that patients implanted with the custom total knee arthroplasty (TKA) experience significant improvements in Knee Society Score (KSS), Knee Injury an Osteoarthritis Outcome Score (KOOS) and higher range of motion from baseline.

Analyzing Outcomes of Unicompartmental Knee Replacement Device

This study looked at the Triathlon Partial Knee Replacement (PKR) device. The study was a prospective, post-market evaluation studying 18 patients who underwent PKR surgery with Dr. Bryan Huber.

Reported pain during activities, on a scale of 1 – 10, dropped from 6.7 at two weeks down to 3.3 at three months. Overall, pain dropped from 3.8 at two weeks to 1.2 by three months. Patient satisfaction was 9.4 at one year post operatively. The average flexion of the knee increased from 106 degreees at two weeks to 127 degrees at the 3-month mark. [Normal range of motion at the knee is considered to be 0 degrees of extension (completely straight knee joint) to 135 degrees of flexion (fully bent knee joint).] None of the 18 patients required blood transfusion and most left the hospital the day after surgery. Partial knee replacement can be a very successful operation with excellent outcomes.

Dr. Huber is a paid consultant to Conformis and Dr. Macy is a paid consultant to Conventus Orthopaedics. However, no benefits have been or will be received for the subject of their research.