Triangle Orthopaedic Associates, Durham, NC, has completed enrollment in an investigational cervical disc replacement study. Triangle Orthopaedic Associates is one of only 23 United States facilities participating in this research study. The goal of the trial is to determine the safety and effectiveness of artificial disc replacement for patients with severe neck pain due to degenerative disc disease.
The Triangle Orthopaedic Associates facility performed successful surgeries on 26 patients in the cervical disc replacement study, placing them in the top four sites for enrollment, nationwide.
I am very proud of our contribution to this national study, says Thomas A. Dimmig, MD, a spine surgeon with Triangle Orthopaedic Associates and principal investigator for the clinical study. In addition, I believe our patients benefit from our commitment to clinical research and our drive to provide solutions to spine disorders.
Additional investigators for the study include David Musante, MD, and Ralph Liebelt, MD, both spine surgeons with Triangle Orthopaedic Associates.
Patients who participated in this trial have reported the benefits of the cervical disc replacement. David Forsythe of Creedmoor is one patient who can attest to his experience of participating in this surgery.
I had no control over the pain, Forsythe explains. My hands and arms would go completely numb after only minutes of physical activity. There was nothing I could do to mitigate the painit had a life of its own.
The 49-year-old executive director for Person County Group Homes dealt with this unrelenting pain for 2 years before undergoing surgery in August 2005. Cortisone injections, various treatment therapies and exercise programs all failed to relieve his chronic pain. Unpredictable levels and duration of pain prevented Forsythe from enjoying his favorite pastimes, such as fixing up group homes on Saturdays. The constant interruption of his daily routine prompted Forsythe to call on his primary doctor, who told Forsythe about Musante and the study at Triangle Orthopaedic Associates.
Meeting with Dr. Musante was the first step in gaining my life back, says Forsythe. He talked through the procedure with me, provided hundreds of pages of literature, and helped me decide that disc replacement was a better choice than fusion. The disc worked so well that I began feeling better after only three days.
Two weeks after surgery, Forsythe was medication-free and on his feet again. The pain and limitations he once experienced were completely gone, and David was finally able to live his life again.
I couldnt have asked for it to work any better, says Forsythe.
The study is evaluating the Kineflex/C cervical disc implant from SpinalMotion, a Mountain View, Calif-based artificial disc developer. Composed of two metal endplates and a metal core, the Kineflex/C disc is implanted into the cervical disc space after removal of the diseased disc. This next-generation technology is designed to maximize the longevity of the implant while preserving motion of the disc, as opposed to traditional fusion procedures, which stop motion.
The SpinalMotion cervical disc replacement study is one of thirteen clinical trials Triangle Orthopaedic Associates has participated in during the past year. Like other investigative trials performed by Triangle Orthopaedic Associates, this cervical disc replacement trial provides hope for patients who feared the drawbacks associated with traditional surgical treatments for severe neck pain.
The 26 surgeries are now complete. As part of the study, patients will receive follow-up treatment for a minimum of 2 years from the specialists at Triangle Orthopaedic Associates.
