The Successes of CBA’s in Arthrodesis

Within the next decade, the number of arthrodesis procedures is expected to continue to increase due to aging populations and complex combinations of diseases in individuals. The goals of arthrodesis procedures are to decrease pain, increase mobility, and improve one’s overall quality of life.

Arthrodesis typically focuses on the reversal of disability associated with arthritis, trauma, diabetes, instability, or misalignment in joints, and successful procedures can depend on numerous risk factors. Considerations you should take into account beforehand include levels of tobacco or alcohol abuse, osteoporosis, use of anti-inflammatory drugs, age, and weight.

The quantity of autograft is sometimes limited, and the bone quality can be poor. This is especially common in older patients and those with a combination of physical difficulties. A second surgery may be required to reduce pain and improve mobility in these individuals, though a variety of bone graft substitutes have since been developed. These new developments range from synthetic matrices, to bone marrow aspirates, though, until recently, none of these substitutes consisted of bone-forming cells.

Breaking down cellular bone allografts (CBA’s), they biologically provide three properties that are necessary for proper bone formation. These include osteoconductive scaffolds, osteoinductive growth factors, and osteogenic cells. Orthofix’s Trinity Elite is a cryopreserved CBA that contains at least 500,000 living cells per CC, the donors of which are strictly screened by MTF based on multiple criteria like age and overall health. In the end, less than 3% of donors are accepted, showing how high the standards are for those that wish donate.

In order to measure CBA’s effects in arthrodesis procedures, a clinical trial was performed for 103 patients undergoing foot and/or ankle arthrodesis, of which were enrolled at 10 institutions and at least 18 years of age. The patients varied for their needs to undergo the procedure, ranging from arthritis, to deformities, to degenerative joint disease. 92 of these individuals successfully completed their 6-month follow-ups after the procedures were done, the primary endpoint being successful fusion after this time, following CT scans that confirmed such findings.

 
To simulate real life scenarios, patients considered high-risk were not excluded from the study. The use of CBA’s did not raise any concerns in terms of safety seeing as there were no adverse effects or infections in those that participated either. Statistically significant improvements in pain and function were noted at the end of the study, which notably improved throughout the entire process, thus showing the success CBA’s have in arthrodesis procedures.

For more, visit Benn-Willcox.com!

Advertisements

The Trinity ELITE® Allograft

Orthofix’s impressive line of products is continued with their third generation allograft, the Trinity ELITE. Processed by the Musculoskeletal Transplant Foundation, a nonprofit organization dedicated to providing quality types of tissue, this fully moldable implant with viable cells provides a unique alternative to autografting.

With over 150,000 Trinity Evolution® procedures to date, the Trinity ELITE adds to the already honorable portfolio. This product focuses on the three physiological components of robust bone formation: osteoconductive scaffold (interconnected scaffold meant for bone ingrowth), verified osteoinductive potential (which is demineralized cortical bone), and a reliable number of cells contained within the bone matrix. Osteogenic cells include adult mesenchymal stem cells and osteoprogenitor cells.

Every step taken in the creation of the Trinity ELITE is done so with the intent of maximizing the health and vitality of mesenchymal cells, also called MSCs, and osteoprogenitor cells, or OPCs. Studies show that MSCs have short lifespans, and decline with age. As these cells age, their abilities to regenerate may decline as well. In Trinity ELITE, the health of these cells starts with the quality.

Before these products are created, Orthofix demands a number of requirements. These include strict donor screening processes, time-sensitive processing, controlled rate of freezing for optimal cell vitality, cryopreservation in liquid nitrogen at -185℃, and a passing of the Musculoskeletal Transplant Foundation’s stringent release criteria. The expiration date of Trinity ELITE products must reflect real time testing.

For those in need of surgical repair or improvements of any bone, the Trinity ELITE is the best option available. Because of its fully moldable design, its viable cells, and a minimum of 500,000 cells per cubic centimeter, Orthofix’s revolutionary product provides a potentially much more beneficial alternative to autografting.

For more on this and other products, visit Orthofix.com, and my blog BennWillcox.net!