WALNUT CREEK, Calif.--(BUSINESS WIRE)--Providence Medical Technology, Inc., an innovator in tissue-sparing cervical fusion technology, today announced that its two-year radiographic and clinical outcomes data of posterior cervical fusion using an expandable implant are being presented at Spine Week 2016 in Singapore.
The prospective, single-arm, multi-center study collected outcomes from 53 out of 60 patients who originally underwent posterior cervical fusion for spondylotic radiculopathy using the DTRAX® system of instruments and implants. The study found that surgical management with the DTRAX® system led to:
- A clinically significant reduction in NDI (32.3 vs. 9.1 (p<0.0001)), VAS Neck Pain (7.4 vs. 2.6 (p<0.0001)), VAS Arm Pain (7.4 vs. 2.6 (p<0.0001), SF-12 PCS (34.6 vs. 43.6 (p<0.0001)), and SF-12 MCS (40.8 vs. 51.4 (p<0.0001))
- No significant changes in overall or segmental lordosis after surgery
- Radiographic fusion rate of 98.1%
- No device failure, implant lucency, or surgical re-interventions
“The two-year results of this study are promising and suggest DTRAX technology is a valuable addition to the armamentarium of options for surgeons treating patients with cervical radiculopathy,” states Dr. Kris Siemionow, University of Illinois at Chicago.
Approximately 500,000 patients worldwide undergo cervical spine surgery each year.
“Providence has been committed to providing clinical evidence since the company’s inception,” commented Jeff Smith, Chief Executive Officer of Providence Medical Technology. “We are encouraged by this evidence supporting the safety and efficacy of decompression and stabilization with DTRAX technology for the treatment of cervical radiculopathy. We believe that DTRAX technology fills critical gaps in the continuum of traditional cervical spine care.”
About Providence Medical Technology, Inc.
Providence Medical Technology, Inc. is a privately-held medical device company developing innovative solutions addressing the $2 billion worldwide cervical spine market. The company is focused on commercializing the DTRAX® platform of single-use, tissue-sparing instruments and implants for cervical fusion, as well as other technologies that improve cervical spine procedures for both physicians and patients. For more information, visit www.providencemt.com.
DTRAX is a registered trademark of Providence Medical Technology, Inc.