Orthofix touts high fusion rates in Trinity Evolution study

Orthofix (NSDQ:OFIX) today announced the publication of a 12-month study which examined the use of its Trinity Evolution cellular bone allograft in patients undergoing vertebral fusions, touting a greater than 90% fusion rate at 12 months

The study was published in the European Spine Journal, Lewisville, Texas-based Orthofix said.

“We are committed to investing in meaningful clinical research to aid physicians in their treatment decisions. These results are important as they further substantiate that Trinity Evolution is effective even in challenging patient populations who might not respond well to traditional allograft and autograft materials,” Orthofix chief scientific officer James Ryaby said in a press release.

The study evaluated the use of the Trinity Evolution, in combination with a PEEK interbody spacer and supplemental anterior fixation, for single level fusions at the vertebral locations between C3/C4 and C6/C7, the company said.

The primary endpoint for the trial was radiographic fusion status based on review of CT scans and radiographic review of angular motion, Orthofix said. Secondary endpoints included neck function as assessed by the Neck Disability Index and neck and arm pain ratings as assessed by Visual Analog Scales.

“To alleviate pain and neurological deficits resulting from nerve compression caused by degenerative disc disease, the most common recourse is surgical decompression through an anterior approach followed by the insertion of a structural interbody spacer filled with bone graft material. This study demonstrated the effectiveness of Trinity Evolution in achieving a solid fusion when used in this manner, indicating that it is a viable option for patients needing anterior cervical discectomy and fusion,” co-author Dr. Timothy Peppers of Scripps Hospital said in a prepared statement.

Orthofix reported significantly improved neck function and neck/arm pain at 6 and 12 months, with no serious adverse events related to the Trinity Evolution. Fusion rates were 78.6% at 6 months and 93.5% after 12 months.

“MTF is committed to research to ensure innovative clinical options exist for all patients. We are pleased these results support the use of a high quality MTF allograft like Trinity Evolution to augment the patients’ recovery,” MTF CEO Bruce Stroeversaid in prepared remarks.

Last September, Orthofix touted results from a study of its Trinity Evolution cellular bone allograft, reporting joint fusion rates above 85% after 1 year. The study was published online in the Foot & Ankle Internationaljournal.

The 92-patient trial is the largest safety and effectiveness trial to date for the graft, according to the Lewisville, Texas-based company.

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