The AdventTM Cervical Disc Clinical Trial
Dr. Hugo Benalcazar, of the Spine Center at Sinai Hospital, and his co-investigators, Drs. Zeena Dorai and Neal Naff, are participating in a clinical trial to investigate a new device called the AdventTM Cervical Disc. The AdventTM Cervical Disc is one of the first artificial cervical discs for the treatment of one-level degenerative disc disease to incorporate a flexible elastomer core, which is designed to provide advanced biomechanical properties.
The purpose of the research study is to evaluate the safety and effectiveness of the AdventTM Cervical Disc in patients who have neck problems and require surgery to replace the disc found between the cervical vertebrae following discectomy. Patients who have undergone at least a 6-week course of conservative treatment for nerve root and/or spinal cord compression due a herniated disc and/or osteophyte formation between cervical discs C3 and C7 and still have no alleviation of their symptoms may be eligible for enrollment in the study. Enrollment eligibility will be confirmed by patient history (e.g., neck and/or arm pain), functional and/or neurologic deficit (e.g., numbness, weakness, diminished or pathologic reflexes, gait disturbances), and radiographic studies (e.g., CT, MRI, x-rays).
Caution: The AdventTM Cervical Disc is an investigational device and is limited by Federal Law to investigational use.
For more information, please contact the following research coordinators:
Alan Orpia: 410-601-0960
Chi Tran: 410-601-1915
About Orthofix International N.V.
This clinical trial is sponsored by Orthofix International N.V. (NASDAQ: OFIX), a global diversified orthopedic products company that offers a broad line of minimally invasive surgical and nonsurgical products for the spine, orthopedic, and sports medicine market sectors that address the lifelong bone-and-joint health needs of patients of all ages, helping them to achieve a more active and mobile lifestyle. Orthofix's products are widely distributed around the world to orthopedic surgeons, hospitals, and patients via Orthofix's sales representatives and its subsidiaries, including Breg, Inc., and Blackstone Medical, Inc. For more information about Orthofix, please visit www.orthofix.com.
