Evaluation of Trinity Evolution in Patients Undergoing Ankle Fusion

2014-08-27 03:18:54 | BioPortfolio


The purpose of this study is to utilize Trinity Evolution as a graft source in tibiotalar arthrodesis and to follow the subjects to measure the clinical outcomes and fusion rate. The hypothesis of the study is that Trinity Evolution will result in tibiotalar fusion rates and clinical outcomes similar to those obtained from autograft and other routinely used allograft materials; these include: fusion, improvement in pain, improvement in function, and absence of adverse events related to the use of the graft source.


Symptomatic arthritic conditions of the ankle including osteoarthritis, post-traumatic arthritis, inflammatory arthropathies and others can be painful and disabling conditions that lead to a reduced quality of life. Major symptoms include pain, stiffness, swelling, and difficulty walking. Many patients may be initially treatable with non-invasive measures such as analgesics, ankle-foot orthosis, physical therapy and medications such as steroids; however, over time, surgery becomes necessary to improve quality of life and maintain function. Tibiotalar arthrodesis is a well-known procedure that can reduce pain and result in an ankle that can withstand an active lifestyle.

Bone graft is used to stimulate new bone formation at the operative site by providing osteogenic cells with osteoinductive factors with an osteoconductive matrix. Although autologous bone is often used as the structural graft material for tibiotalar fusion, donor site morbidity (e.g., pain, infection, and fracture), limited supply, and inconsistent osteogenic activity continue to be associated problems. The quality of an autograft is dependent upon the age and medical condition of the patient, as well as the number of viable mesenchymal and osteoprogenitor stem cells that are present in the specimen. This tissue is harvested during the surgical procedure; the process can prolong morbidity at the harvest site. The ideal bone graft would offer osteogenic cells, osteoinductive factors, and an osteoconductive matrix with a consistent supply of viable mesenchymal stem cells (MSCs) and osteoprogenitor cells (OPCs)—but without the morbidity of autograft.

Due to the limitations associated with autograft, researchers are pursuing the use of bone-graft substitutes for the promotion of tibiotalar arthrodesis. Bone-graft substitutes now being used by surgeons include ceramic synthetics, bone morphogenic proteins (BMPs), demineralized bone matrices (DBMs) and other allografts; these may be used alone or in combination. Allografts available as substitutes for autograft offer some of the benefits of autograft without its limitations—but do not contain viable MSCs and OPCs.

Trinity Evolution is an allogeneic cancellous bone matrix containing demineralized cortical bone (DCB) as well as viable osteoprogenitor and mesenchymal stem cells. Adult mesenchymal stem cells and osteoprogenitor cells, such as those in Trinity Evolution, are the precursor cells that differentiate into osteoblasts—the cells responsible for bone growth and repair.

Trinity Evolution is a novel, allogeneic cancellous bone matrix that provides the required osteoconduction, osteogenesis, and osteoinductivity necessary for successful bone grafting. It offers viable osteoprogenitor and mesenchymal stem cells and demineralized cortical bone—all in a single product. Data from preclinical studies with Trinity Evolution have demonstrated in-vitro and in-vivo safety and effectiveness. Trinity Evolution is considered an allograft and as such is a "minimally manipulated" tissue and is labeled for bone repair for all orthopedic and podiatric indications where autograft is used. In this study Trinity Evolution will be used as a substitute for autograft and/or allograft in tibiotalar arthrodesis.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Tibiotalar Arthrodesis With Hind Foot Fusion


Trinity Evolution


San Diego
United States




Orthofix, Inc.

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:18:54-0400

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