LEWISVILLE, Texas--(BUSINESS WIRE)--
Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical
device company, today announced results from the largest study conducted
to date evaluating the safety and effectiveness of their cellular bone
allograft (CBA), Trinity Evolution®, in foot and ankle
arthrodesis (fusion) procedures. Published online in Foot
& Ankle International, patients treated with Trinity
Evolution demonstrated per joint fusion rates of 86.8 percent at 12
months follow-up. Additionally, successful fusion significantly
correlated with improvements in pain, function, and Quality Of Life
(QOL), even in patients with comorbidities such as obesity, diabetes and
smoking.
"The goal of arthrodesis in foot and ankle fusion procedures is to
decrease pain and improve function and quality of life by reversing
disability associated with arthritis, trauma, diabetes and a variety of
other conditions," said Dr. James Nunley, Professor of Orthopaedic
Surgery and Director of Foot & Ankle Surgery at Duke University Medical
Center and senior author of the journal article. "This study observed
fusion rates using Trinity Evolution that were higher than or comparable
to fusion rates in other published studies of autologous
corticocancellous bone graft (autograft), a traditional gold standard
used in foot and ankle procedures."
In this prospective, multicenter, open-label clinical study, Trinity
Evolution was evaluated in 92 patients undergoing 153 foot and ankle
fusion procedures. Compared with previous studies, this trial used
prospective enrollment and included patients who were at high risk for
bone fusion failure due to age, diabetes or obesity. The primary
endpoint was successful fusion based on high resolution CT scans and
radiographs assessed by an independent lab. Based on radiographic
effectiveness, the study demonstrated a per joint fusion rate of 81.1
percent (124/153) at six months, which increased to 86.8 percent
(112/139) at 12 months. Additionally, comorbid factors known to be
associated with fusion failure (pseudoarthrosis), such as diabetes, age
and obesity, did not have a negative effect in this study. There were no
serious adverse events attributable to Trinity Evolution as determined
by an independent consultant.
"This study is evidence of our commitment to invest in clinical research
to provide physicians the information they need to make the best choices
for their patients," said Orthofix Chief Scientific Officer James Ryaby,
Ph.D. "We designed this study to include diabetic, obese and older
patients often seen by foot and ankle specialists who might not respond
well to traditional allograft and autograft materials. These results
support Trinity Evolution as an important alternative to autograft and
other bone growth materials in this difficult-to-treat patient
population."
Procedures using autograft often require a second surgical site to
harvest the bone. This can cause complications such as pain from the
bone removal site and infection. In addition, the quality of the bone
harvested can be poor, especially in older individuals or patients with
other health issues.
About Trinity Evolution
Trinity Evolution is a cryopreserved CBA from allograft donor bone that
facilitates effective bone formation by providing an osteoconductive
scaffold, osteoinductive growth factors and osteogenic cells. Trinity
Evolution eliminates the need for harvesting autograft from patients,
which reduces operating time and expense as well as discomfort and
potential complications.
Processed by the Musculoskeletal
Transplant Foundation (MTF), a nonprofit organization dedicated to
providing quality tissue, Trinity Evolution is the predecessor of Trinity
Elite®, a moldable bone graft material that enables
physicians to easily control the placement of tissue during procedures.
To date there have been more than 135,000 procedures using Trinity
Evolution and Trinity Elite.
About Orthofix
Orthofix International N.V. is a diversified, global medical device
company focused on improving patients' lives by providing superior
reconstructive and regenerative orthopedic and spine solutions to
physicians worldwide. Headquartered in Lewisville, Texas, the Company
has four strategic business units that include BioStim, Biologics,
Extremity Fixation and Spine Fixation. Orthofix products are widely
distributed via the Company's sales representatives, distributors and
its subsidiaries. In addition, Orthofix is collaborating on research and
development activities with leading clinical organizations such as the
Musculoskeletal Transplant Foundation and the Texas Scottish Rite
Hospital for Children. For more information, please visit www.orthofix.com.
About MTF
The Musculoskeletal Transplant Foundation, a non-profit organization
based in Edison, NJ, is a national consortium comprised of leading organ
procurement organizations, tissue recovery organizations and academic
medical institutions. Since its inception in 1987, MTF has received
tissue from more than 100,000 donors and distributed more than 6 million
grafts for transplantation. For more information, visit www.mtf.org.
Forward-Looking Statements
This communication contains certain forward-looking statements under the
Private Securities Litigation Reform Act of 1995. These forward-looking
statements, which may include, but are not limited to, statements
concerning the projections, financial condition, results of operations
and businesses of Orthofix and its subsidiaries and are based on
management's current expectations and estimates and involve risks and
uncertainties that could cause actual results or outcomes to differ
materially from those contemplated by the forward-looking statements.
The forward-looking statements in this release do not constitute
guarantees or promises of future performance. Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. The
Company undertakes no obligation to update or revise the information
contained in this press release.
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Orthofix, International N.V.
Investor Relations:
Mark Quick,
214-937-2924
markquick@orthofix.com
or
Media
Relations:
Denise Landry, 214-937-2529
deniselandry@orthofix.com
Source: Orthofix International N.V.
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