LEWISVILLE, Texas--(BUSINESS WIRE)-- Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the presentation of multiple clinical and scientific abstracts during the International Society for the Advancement of Spine Surgery (ISASS) annual meeting in San Francisco June 1-3, 2023.
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Illustration of the Orthofix M6-C artificial cervical disc. (Graphic: Business Wire)
“We are pleased to support a wide range of abstracts and clinical data during the annual ISASS meeting, including the first presentation of the seven-year data from the M6-C artificial cervical disc U.S. IDE study,” said Kevin Kenny, President of Global Spine. “ISASS is an important opportunity for attendees to learn from a distinguished surgeon panel that will provide their insights about cervical disc replacement and long-term outcomes of this therapy. Additionally, we are proud to support presentation of data for our Bone Growth Therapy and Biologic solutions.”
At the ISASS annual meeting, Orthofix is presenting a variety of industry abstracts and posters focused on the company’s M6-C™ artificial cervical disc, CervicalStim™ bone growth stimulator and Trinity Elite™ Allograft with viable cells.
Motion Preservation
“M6-C Artificial Cervical Disc: Seven-Year Outcomes for Single-Level Total Disc Replacement with a Novel Viscoelastic Artificial Cervical Disc” – abstract presentation by Dr. Todd Lanman.
This abstract is the first public presentation of specific seven-year clinical results associated with the use of the M6-C artificial cervical disc for the treatment of single-level symptomatic cervical radiculopathy. The presentation will be on Saturday, June 3 at 10:00 a.m. in Salons 10-12 by Dr. Todd Lanman. Highlighted results include:
- Decreases in disability as measured by NDI and decreases in Neck and Arm Pain Scores that were observed at prior follow-up periods and were retained through seven-years post-op
- Eleven Secondary Surgical Interventions (SSI) were observed among the M6-C disc cohort (6.9%). This rate is comparable to seven-year SSI rates reported for other commercially available artificial cervical discs
- Annual follow-up of this cohort will continue through 10-years post-op
“Cervical Disc Arthroplasty Expert Panel: Osteolysis and Periprosthetic Bone Changes in Cervical Disc Replacement” – academic program session with moderator Dr. Gunnar Andersson and speakers Dr. Josh Jacobs, Dr. Armen Khachatryan, Dr. Todd Lanman, Dr. Steven Kurtz and Dr. Sophia Sangiorgio.
This multidisciplinary panel of clinicians and researchers will discuss the assessment of bone changes around artificial cervical disc implants, leveraging prior research in hip and knee arthroplasty. Panel will be conducted on Friday, June 2 at 1:20 p.m. in Salons 10-12. Topics covered include:
- Categorization and classification of radiographic observations
- Clinical management of observed bone changes post-cervical disc replacement
“Proposed Classification System of Radiographic Bony Changes after Cervical Disc Replacement” – poster by Dr. Armen Khachatryan.
Poster will be located in the Exhibit Hall. Content highlights include:
- Introduction of classification system for post-cervical disc replacement radiographic observations
- Analysis of system reliability
Bone Growth Therapy
“CervicalStim Bone Growth Therapy: Electrical Stimulation Used as an Adjunct to Cervical Spine Fusion in Patients at Risk for Pseudarthrosis” – podium presentation with Dr. Ilyas Aleem.
This presentation will cover the results of a prospective multicenter study that evaluated the adjunct effect of PEMF in subjects undergoing cervical spinal surgery who presented with risk factors for pseudarthrosis (multilevel fusion, prior failed cervical spine fusion, diabetes, osteoporosis, or nicotine use). Presentation will be conducted on Saturday June 3, at 10:32 a.m. in Salons 13-15. Highlights include:
- Out of 160 subjects, 144 (90.0%) were graded as fused (all levels) at the 12-month visit
- Fusion success was 91.7% (n=55/60) for subjects with a single risk factor, 89.0% (n=89/100) for subjects with two or more risk factors, and 90.9% (n=20/22) for subjects with three or more risk factors
- Significant improvements in NDI, VAS (arm and neck), SF-36, and EQ-5D were observed compared to baseline scores (p