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.

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